by Debbie Cenziper and Megan Rose

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Joe DeMayo always knew his healthy years could end abruptly, bound to the lifespan of a transplanted kidney about the size of a small fist. But as the father of a toddler, he had hoped to have more time.

When he was 33, his wife had donated her kidney to him, a milestone that changed the course of DeMayo’s life. The relentless fatigue, nose bleeds and itchy skin brought on by his own poorly functioning kidneys vanished, and he felt good enough to leave home in Philadelphia for a new beginning in the foothills of northern California.

Over long afternoons, DeMayo would hike in the mountains with his wife and their black-and-white mutt, Fausto. When his son was born, he’d imagined himself coaching baseball games, clad in Phillies gear.

But his donated kidney started to fail in early 2023, much earlier than expected. The decline came as a surprise to DeMayo, who had been faithfully taking his medications, including tacrolimus, an essential immunosuppression drug that helps stave off organ rejection.

Joe DeMayo, his wife and son at Christmas in 2022. About a year later he would have a second kidney transplant. (Courtesy of Joe DeMayo)

DeMayo didn’t know at the time that the capsules he swallowed twice a day precisely 12 hours apart could have left him vulnerable — or that one of the most formidable drug regulators in the world may have failed to protect him.

As he grew weaker, his kidney unable to cleanse his body of excess fluid and waste, investigators from the Food and Drug Administration headed to western India to inspect the factory that manufactured DeMayo’s tacrolimus and other generic drugs for American consumers.

It was at least the eighth time since 2015 that the FDA had been there, and each of those visits had uncovered problems in the way the drugs were made, government records show.

During the inspection in the spring of 2023, investigators discovered the Intas Pharmaceuticals factory had, among other things, manipulated drug-testing records to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company’s drugs.

Unaware of the inspection, DeMayo continued taking his tacrolimus capsules. He fought exhaustion and struggled to hold onto his job behind a deli counter.

“Daddy needs a new kidney,” he recalled telling his 5-year-old son at the time.

DeMayo’s tacrolimus medication (George Etheredge, special to ProPublica)

That November, the FDA barred the Intas factory from exporting drugs to the United States. But under a long-standing practice uncovered by ProPublica, the agency excluded certain medications from the factory-wide ban, including tacrolimus, allowing the drugs to continue flowing to the U.S.

In a statement to ProPublica, Intas, whose U.S. subsidiary is Accord Healthcare, said that the company could not comment on the cases of individual patients but that its tacrolimus is safe and effective. The company said it immediately responded to the FDA’s inspection findings, launching a program focused on quality and investing millions of dollars in upgrades and new hires. Intas also said that some exempted drugs were never shipped to the United States but would not provide details.

“Intas is well on its way towards full remediation of all manufacturing sites,” the company said.

ProPublica’s investigation found the FDA has allowed more than 150 drugs or their ingredients from banned factories into the country over the past dozen years, ostensibly to prevent drug shortages.

The agency did not routinely test the drugs or actively look for signs of sudden or unexplained reactions among patients. And the exemptions were largely kept hidden from Congress and the public, including patients like DeMayo, who counted on his medication to keep him alive.

DeMayo filled another prescription for tacrolimus only days before the FDA exempted it from the Intas import ban and continued taking the capsules until just before his second transplant surgery at Temple University Hospital in January 2024.

“I’m trying to do the right thing, take all my medicine,” said DeMayo, 45, who took Intas tacrolimus for two years. “If I’m doing all that, shouldn’t somebody be doing their due diligence?”

In a statement, the FDA said drugmakers that receive a pass from import bans are required to conduct additional safety and quality testing and hire third-party experts to assess the results before shipping medication to the United States. Current and former FDA officials said those measures are faulty. Many of the companies have been cited before for testing protocols that were ineffective or prone to fraud.

DeMayo, now recovered from his second transplant surgery, gave ProPublica two bottles of his unused Intas tacrolimus capsules. ProPublica had them tested at Valisure, an independent, accredited lab in Connecticut.

The Testing Process

I. Preparation Valisure conducted three separate tests on DeMayo’s medication. For two of the analyses, technicians emptied the material inside the capsules onto a scale so precise that it protects samples from the movement of air. The material was then put into a solution for testing.

II. Assessment for Dosage For the first assessment, technicians used a machine to separate, identify and quantify compounds in the solution.

The liquid was poured into tiny vials and then assessed for physical and chemical properties. The analysis revealed how much of the medication’s key ingredient was present and whether it matched the dosage levels described on the label.

III. Testing for Contaminants Valisure also tested the drug for the presence of toxic elements, including lead, arsenic and mercury. The liquid was put into a machine that breaks down chemicals into atoms using plasma that is 18,000 degrees — hotter than the surface of the sun.

IV. Testing for Dissolution In the third assessment, a technician prepared a liquid that simulates stomach acid.

Then, the technician placed the pills into small metal cages and dropped them into the liquid.

The testing machine measured how fast the drug dissolved and whether the capsules provided the right amount of medication at the right time.

(Photography by George Etheredge, special to ProPublica)

In their first test, the scientists at Valisure found that some of DeMayo’s pills contained an adequate amount of the key ingredient but others contained a lower amount than the minimum level set by U.S. regulation. Pharmacists, doctors and other experts said underdosing can leave patients vulnerable to organ rejection.

Valisure did not find any substantive contamination in DeMayo’s medication.

But the scientists found another potential problem. The capsules dissolved quickly — up to three times faster than the name brand. Rapid dissolution can introduce too much of the drug too quickly, experts said, potentially causing tremors, headaches and kidney failure.

Note: Data was modeled by Valisure using the Weibull model. The chart depicts modeled data for 1 mg capsules. (Lucas Waldron/ProPublica)

ProPublica did not test tacrolimus made by any other manufacturer. In its statement, Intas said that the findings are “unrelated to the [FDA’s] inspections” and that the FDA had determined the drug was equivalent to the brand-name version when it was first approved for the U.S. market.

Valisure previously tested Intas’ tacrolimus for the Department of Defense, which is conducting safety and quality testing on more than three dozen drugs commonly used by U.S. service members and their families. Those tests, too, showed the capsules dissolved too quickly.

“This is an alarming signal of other quality issues that can be affecting patient care,” said retired Army Col. Vic Suarez, who helped launch the Defense Department effort and is assisting on the project.

The FDA conducted its own studies of Intas’ tacrolimus in recent years and reported a similar result on its website. The agency noted there was no apparent risk of organ rejection but said the Intas generic could create toxins in the body, which can cause kidney damage. The FDA said the capsules may not provide the same therapeutic effect as the brand-name version.

The findings were made public in September 2023. Weeks later, the agency went on to excuse the drug from the Intas import ban, allowing the company to continue shipping tacrolimus to the United States.

Janet Woodcock, who for years led the FDA’s Center for Drug Evaluation and Research, said in an interview that the results of the testing are concerning and that the agency should quickly “try to sort them out.”

“This obviously was a quality problem,” she said.

Woodcock did not say why the FDA exempted the drug from the import ban imposed on the Intas factory. Though Woodcock approved exemptions for years, she had left the center and was serving as the FDA’s principal deputy commissioner when the exemptions for tacrolimus and other Intas drugs were made.

DeMayo said he’ll never know whether the medication contributed to the loss of his donated kidney. Organ rejection, which can happen quickly or over years, is among the most common causes of kidney failure in transplant patients, but kidneys can fail for other reasons, too, said Joseph Vassalotti, chief medical officer at the National Kidney Foundation.

In DeMayo’s case, he was hospitalized with a stomach virus and dehydration the same year his kidney function started to decline. Still, he questions the drug that was supposed to protect him and worries that other transplant patients who have taken Intas tacrolimus could be at risk.

One and a half years after the FDA banned the factory from shipping drugs to the United States, tacrolimus is still excluded. A customer service agent for the company said Intas recently stopped distributing the drug, but the company did not respond to a request for comment.

“The people who oversee the pills are failing and the people who are making the pills are failing,” DeMayo said. “How did it get so bad?”

In January, one year after his second kidney transplant, DeMayo went to Temple University Hospital for a follow-up appointment. (First and third photos: Hannah Yoon for ProPublica. Second photo: George Etheredge, special to ProPublica.)

Lucas Waldron contributed graphics and development.

by Eli Hager

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up for Dispatches, a newsletter that spotlights wrongdoing around the country, to receive our stories in your inbox every week.

The New York State Legislature this week passed a bill banning anonymous complaints to the state child abuse hotline. If Gov. Kathy Hochul signs the legislation, New Yorkers will now have to provide their name and contact information if they want to make an allegation that someone might be neglecting a child.

This dramatic change in the law comes a year and a half after a ProPublica investigation showed how the hotline had been weaponized by jealous exes, spiteful landlords and others who endlessly called in baseless allegations. Even if a caller didn’t leave their name or any details, and even if the same allegation had repeatedly been investigated and found to be unsubstantiated, it automatically triggered an invasive search of the accused’s home and often a strip search of the children.

We detailed the case of one Brooklyn mother whose apartment was searched dozens of times — by police officers and child protective services caseworkers who never had a warrant and often showed up at her door after midnight — all because an angry former acquaintance kept anonymously calling the hotline about her. She was never found to have mistreated her children in any way.

According to federal statistics, 96% of anonymous calls to child abuse hotlines are deemed baseless after an investigation. Among all allegations of child abuse or neglect, including non-anonymous calls, 83% are ultimately deemed unfounded.

In New York, more than 4,000 children every year had experienced child protective services investigations as a result of anonymous calls — until now.

The legislation passing is “a win-win for everybody,” said Democratic state Sen. Jabari Brisport, the bill’s sponsor. Not only will it protect victims of domestic violence who may have an abusive current or former partner who has used the anonymous reporting system to harass them or to influence a custody dispute, it will also help caseworkers themselves, Brisport said. “They are stretched so thin already,” he said. “By reducing the number of these false complaints, we can let them do their jobs better.”

“But the fact that false reports make such an effective method of harassment is a symptom of deeper issues in how CPS operates,” Brisport added, referring to how the home searches and investigations that result from these calls often turn families’ lives upside-down. Black parents especially are affected, he said, and they can feel helplessly unable to comfort their children through a terrifying and opaque process that can lead to their separation from their mom and dad.

A committee of the U.S. Commission on Civil Rights last year published a report that cited ProPublica’s journalism on these issues and called on New York to abolish anonymous reporting. ProPublica’s articles were also circulated among lawmakers and legislative staff in Albany both last year and this spring.

California and Texas, too, have passed legislation to curtail anonymous reporting. Several other states are considering similar bills.

New York’s new law will maintain the confidentiality of callers to the child abuse hotline, just not their anonymity. That means that if someone thinks that a family member, neighbor or colleague is harming a child, and they call it in, they can still be assured that the state will not reveal their identity to the alleged abuser or publicly in any way. The caller will just have to provide their name and contact information so that caseworkers can follow up, in part to make sure that they don’t have an ulterior motive for making a malicious accusation and so that caseworkers can gather more details from the caller to conduct a more informed investigation.

If they refuse to identify themselves, hotline staff will decline to pass along the tip to child protective services. But an amendment was added to the bill stating that if a caller doesn’t want to leave their name, they can still speak to a supervisor, who will then explain to them that if they provide their name it will remain confidential; that intentionally making a false report is illegal; and that issues involving children in need can also be addressed through housing, food and other services. Contact information for such services will be provided.

The new law will not affect mandated reporters of child abuse, such as teachers and police officers, who already were not anonymous.

Chris Gottlieb, director of the NYU School of Law Family Defense Clinic, helped to shepherd the legislation to its passage. She said that when she used to bring up this issue in Albany — and talk about how child protective services agents searching families’ homes without a warrant can be deeply traumatizing for both parents and children — she was often met with blank stares. But then ProPublica’s reporting “helped to change the conversation,” she said, and more importantly, parents themselves, many of them Black and Latino and led by the community organizer Joyce McMillan, started holding regular rallies on the steps of the Legislature and testifying at hearings.

In fact, parents have filed a first-of-its-kind class-action lawsuit challenging warrantless child protective services searches of their homes as unconstitutional. New York City is contesting the suit, but the city’s Administration for Children’s Services has said that it is committed to addressing child safety concerns while also respecting families’ rights.

In past statements to ProPublica, ACS has said that it is required by state law to investigate fully and to seek to conduct a home assessment whenever it receives a report of child maltreatment from the state, no matter the original source of that report. But a spokesperson said that the agency supports anonymous reporting reform with the perspective that protections for children who are in danger should also be preserved.

One of the plaintiffs in the class-action suit, Shavona Warmington, praised New York state lawmakers for abolishing anonymous reporting once and for all.

The Queens mother of six alleges that someone called in complaints about her every several months for a decade, knowing that the mere fact of a call would cause caseworkers to pound on her door; threaten that they would call the police if she didn’t let them in; search her refrigerator, cabinets, closets and bed while her kids watched; and then strip search and interrogate them. She said that the content of the reports to the hotline always sounded familiar, clearly from the same person, but that this never mattered.

In the suit, she contended that the person who made the complaints was likely the man who abused her. He could call every day and they would still send somebody out.

Her children have been traumatized by the sound of a knock on the door, she said.

“I have no contact with him otherwise, just through ACS,” Warmington said, referring to her abuser.

by Katherine Dailey and Jessie Nguyen, Medill Investigative Lab

We are still reporting. If you are a current or former FDA employee or someone in the industry with information about the agency, the safety of generic drugs, or the manufacturers that make them, our team wants to hear from you. Megan Rose can be reached on Signal or WhatsApp at 202-805-4865. Debbie Cenziper can be reached on Signal or WhatsApp at 301-222-3133. You can also email us at FDA@propublica.org.

ProPublica has sued the U.S. Food and Drug Administration in federal court in New York, accusing the agency of withholding information about the safety and availability of generic drugs critical to millions of Americans.

For years, Congress, watchdog groups, doctors and others have questioned the quality of generic drugs made in factories overseas. To better understand how the FDA regulates the industry and protects consumers, ProPublica submitted four records requests last year under the Freedom of Information Act.

The FDA declined to quickly release the documents, including records that would identify drugs made at some of the most troubled factories in India. Inspection reports that describe unsafe manufacturing conditions are public, but the FDA redacts the names of the medications made in those factories.

“Americans (including pharmacists, doctors, hospital systems, policy makers) cannot see for themselves which drugs may have been made in unsafe facilities,” the lawsuit said.

ProPublica requested the records as part of an ongoing investigation into the safety of America’s generic drug supply. ProPublica has reported that the FDA allowed some manufacturers to continue shipping their drugs to Americans even after the factories that made them were found in violation of quality standards and banned from the U.S. market. More than 150 drugs or their ingredients were given these little-known exemptions over the past dozen years.

In its response to ProPublica’s initial records request, the FDA said the news organization had not demonstrated “a compelling need” to expedite the release of documents. Since the lawsuit was filed in November, the agency has begun to turn over some of the requested records. The case is still active in federal court in New York.

ProPublica has argued the records will help inform American consumers, who increasingly rely on generic drugs made overseas. Quality concerns have dogged the industry for years: In 2023, four people died after using tainted eye drops made in India, and others had to have their eyeballs surgically removed.

“Every single one of us relies on the FDA to ensure that the medicines we take and give our loved ones are safe,” said ProPublica’s outside counsel, Jack Browning, a partner at Davis Wright Tremaine. “With the increasing prevalence of offshore manufacturing, it is imperative for organizations like ProPublica to ensure that safety violations are not being swept under the rug.”

The Department of Health and Human Services, which oversees the FDA, declined to comment on the case, citing the ongoing litigation.

This is the second time ProPublica has sued the FDA in recent years.

In 2023, the news outlet and the Pittsburgh Post-Gazette filed a lawsuit against the agency for withholding records related to the massive recall of breathing machines made by Philips Respironics. The agency ultimately provided the documents.

Dailey and Nguyen are with Northwestern University’s Medill Investigative Lab in Washington, D.C.

by Annie Waldman

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.

What Happened: A federal judge ruled on Monday that the Trump administration’s termination of hundreds of grants by the National Institutes of Health was “void and illegal,” ordering some of them to be reinstated, including many profiled by ProPublica in recent months.

District Judge William G. Young made the ruling in two lawsuits challenging the Trump administration’s directives and cancellations: One case was brought by more than a dozen states’ attorneys general, and the other was led by the American Public Health Association alongside several other organizations and researchers.

In Monday’s ruling, the judge determined that the directives that led to the grant terminations were “arbitrary and capricious” and said they had “no force and effect.” The judge’s ruling ordered the funding of the grants to be restored. It only covers grants that have been identified by the plaintiffs in the cases.

What the Judge Said: After Young ruled that the agency directives and terminations were illegal, he noted that the government’s practices were discriminatory.

“This represents racial discrimination, and discrimination against America’s LGBTQ community,” he said. “That’s what this is. I would be blind not to call it out. My duty is to call it out, and I do so.”

This year, the Trump administration banned the NIH from funding grants that had a connection to “diversity, equity and inclusion,” alleging that such research may be discriminatory. ProPublica previously found that caught up in mass terminations was research focused on why some populations — including women and sexual, racial or ethnic minorities — may be more at risk of certain disorders or diseases.

“I have never seen a record where racial discrimination was so palpable,” Young said during Monday’s hearing. “I’ve sat on this bench now for 40 years, and I’ve never seen government racial discrimination like this, and I confine my remarks to this record, to health care.”

He also noted the administration’s targeting of LGBTQ+ research. “It is palpably clear these directives and the set of terminated grants here also are designed to frustrate, to stop research that may bear on the health — we are talking about health here — the health of Americans, of our LGBTQ community,” he said. “That’s appalling.”

Background: In recent months, ProPublica has been covering the toll of the grant cancellations by the NIH. More than 150 researchers, scientists and investigators have reached out to ProPublica and shared their experiences, revealing how the terminations are dramatically reshaping the biomedical and scientific enterprise of the nation at large.

They described how years of federally funded research may never be published, how critical treatments may never be developed and how millions of patients could be harmed.

“Two and a half years into a three-year grant, and to all of a sudden stop and not fully be able to answer the original questions, it’s just a waste,” said Brown University associate professor Ethan Moitra, whose grant studying mental health treatment for LGBTQ+ people was terminated.

Response: White House spokesperson Kush Desai said it was “appalling that a federal judge would use court proceedings to express his political views and preferences,” adding that “justice ceases to be administered when a judge clearly rules on the basis of his political ideologies.”

Desai also defended the administration’s policies targeting “diversity, equity and inclusion,” calling it a “flawed and racist logic.” He also said that the administration was committed to “restoring the Gold Standard of Science,” which he claimed involves a recognition of the “biological reality of the male and female sexes.” The NIH, he said, is shifting “research spending to address our chronic disease crisis instead, not to validate ideological activism.”

Andrew G. Nixon, the director of communications for the Department of Health and Human Services, told ProPublica that the agency “stands by its decision to end funding for research that prioritized ideological agendas over scientific rigor and meaningful outcomes for the American people,” and that it was “exploring all legal options, including filing an appeal and moving to stay the order.”

Why It Matters: The mass cancellation of grants in response to political policy shifts has no historical precedent, experts told ProPublica, and marks an extraordinary departure from the agency’s established practices. ProPublica previously revealed that the Department of Government Efficiency — the administration’s cost-cutting initiative —— gave the agency direction on what to cut and why, raising questions about the provenance of the terminations.

The judge's ruling adds to a growing number of legal decisions halting or scaling back the administration’s actions. As of Monday, according to The New York Times, there have been more than 180 rulings that have “at least temporarily paused” the administration’s practices.

Whether the administration follows Monday’s ruling, however, remains an open question. As ProPublica reported, the NIH has previously terminated research grants even after a federal judge blocked such cuts, and the administration has disregarded several other rulings.

“If the vacation of these particular grant terminations, the vacation of these directives, taken as a whole, does not result in forthwith disbursement of funds,” Young said in Monday’s hearing, “the court has ample jurisdiction.”

Were you involved in a clinical trial, participating in research or receiving services that have ended, been paused or been delayed because of canceled federal funding? Our reporters want to hear from you. To share your experience, contact our reporting team at healthfunding@propublica.org.

Asia Fields contributed reporting.

by Debbie Cenziper, Megan Rose, Brandon Roberts and Irena Hwang

We are still reporting. If you are a current or former FDA employee or someone in the industry with information about the agency, the safety of generic drugs, or the manufacturers that make them, our team wants to hear from you. Megan Rose can be reached on Signal or WhatsApp at 202-805-4865. Debbie Cenziper can be reached on Signal or WhatsApp at 301-222-3133. You can also email us at FDA@propublica.org.

On a sweltering morning in western India in 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant surrounded by barricades and barbed wire and demanded to be let inside.

For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers at the tablet presses, mixers and filling machines that produce dozens of generic drugs for Americans.

Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were “blackish” from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown “extraneous matter” were used anyway, mixed into batches of drugs.

Sun Pharma’s transgressions were so egregious that the Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States.

But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America’s drug supply.

A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. Pills and injectable medications that otherwise would have been banned went to unsuspecting patients across the country, including those with cancer and epilepsy.

The FDA didn’t routinely test the medications for quality problems or use its vast repository of drug-related complaints to proactively track whether they were harming the people who relied on them.

And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details.

In the hands of consumers, according to the FDA’s longtime head of drug safety, the information would have caused “some kind of frenzy.”

“We felt we didn’t have to make it a public thing,” said Janet Woodcock, who spent nearly four decades at the agency.

The exemptions for Sun weren’t a one-time concession. A ProPublica investigation found that over a dozen years, the same small cadre at the FDA granted similar exemptions to more than 20 other factories that had violated critical standards in drugmaking, nearly all in India. All told, the group allowed into the United States at least 150 medications or their ingredients from factories with mold, foul water, dirty labs or fraudulent testing protocols.

The FDA inspection report of the Sun Pharma factory in India warned of leaks that could allow dirty water into a sterile area where drugs were made. (Obtained by ProPublica. Highlighted by ProPublica.)

Some of the drugs were recalled — just before or just after they were exempted — because of contaminants or other defects that could cause health problems, government records show. And a ProPublica analysis identified more than 600 complaints in the FDA’s files about exempted drugs at three of those factories alone, each flagging concerns in the months or years after they were excluded from import bans in 2022 and 2023.

The “adverse event” reports about drugs from the Sun plant and two others run by Indian drugmaker Intas Pharmaceuticals described medication with an abnormal taste, odor or residue or patients who had experienced sudden or unexplained health problems.

The reports cite about 70 hospitalizations and nine deaths. And those numbers are conservative. ProPublica limited its count to reports that linked problems to a single drug. However, the total number of complaints to the FDA that mention exempted drugs is in the thousands.

“Abdominal pain … stomach was acting very crazy,” one report said about a woman using a seizure drug from Sun Pharma. The FDA received the complaint in 2023, nine months after it excluded the medication from the import ban.

“Feeling really hot, breaking out with hives, hard to breathe, had confusion, glucose level was high, heart rate went up and head, arms and hands got numb,” noted another report about a patient taking a sedative from Intas. The complaint was sent to the FDA in June 2023, the same month the agency exempted the medication.

The outcomes described in the complaints may have no connection to the drug or could be unexpected side effects. In some cases, the FDA received complaints about the same drugs made by other manufacturers.

Still, the seriousness of the reports involving exempted drugs did not galvanize the agency to investigate, leaving the public and the government with no way of knowing whether people were being harmed and, if so, how many.

Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a “cascade of failure” at one of the Intas plants, finding workers had destroyed testing records, in one case pouring acid on some that had been stuffed in a trash bag. At the second Intas factory, inspectors said in their report that records were “routinely manipulated” to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company’s drugs.

A 2022 FDA inspection report described “a cascade of failure” at one of the Intas plants, noting that employees were observed destroying records “by tearing it into pieces.” (Obtained by ProPublica. Highlighted by ProPublica.)

The FDA barred both plants in 2023 from shipping drugs to the U.S. Then the agency simultaneously granted more than 50 exemptions to those banned factories — the broadest use of exclusions in ProPublica’s analysis.

Intas, whose U.S. subsidiary is Accord Healthcare, said in a statement that the company has invested millions of dollars in upgrades and new hires and launched a companywide program focused on quality. Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing. Intas also said that some exempted drugs were never shipped to the United States because the FDA found other suppliers. The company would not provide details.

“Intas is well on its way towards full remediation of all manufacturing sites,” the company said.

Sun did not respond to multiple requests for comment. When the FDA imposed the ban, the company said it would “undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company’s remedial action. Sun Pharma remains committed to being … compliant and in supplying high-quality products to its customers and patients globally.”

Both companies’ factories are still under import bans.

“We’re supposed to have the best medicine in the world,” said Joe DeMayo, a kidney transplant patient in Philadelphia who took an immunosuppression medication made by Intas until December 2023, unaware that a month earlier the FDA had excused the drug from an import ban. “Why are we buying from people who aren’t making it right?”

Joe DeMayo, a father and grocery store worker, had no idea the capsules he took every day to protect his transplanted kidney were coming from a factory in India that the FDA had banned from the U.S. market. (Hannah Yoon for ProPublica) An excerpt from an FDA inspection of an Intas factory about its manufacturing of sterile drugs (Animation by Lisa Larson-Walker/ProPublica)

Watch video ➜

Game of Chance

How the United States wound up here — playing a game of chance with risky drugs made thousands of miles away — is the story of an agency that has relentlessly pressed to keep the supply of low-cost generics flowing even as its own inspectors warned that some of those drugs posed a potentially lethal threat to the American public.

The vast majority of the prescriptions filled in the country are for generic drugs, from penicillin to blood thinners to emergency contraception, and many of those come from overseas, including India and China. For years, the FDA has vouched for the quality of generics, assuring the public in press releases, speeches and social media campaigns that they are just as safe and effective as brand-name drugs.

That guarantee came under serious question in 2019 when journalist Katherine Eban published a breakthrough book, “Bottle of Lies,” that exposed rampant fraud and manufacturing violations in Indian factories and the FDA’s reluctance to aggressively investigate.

ProPublica identified another alarming level of entrenched failure: Even when the agency did investigate and single out factories that were among the worst in India, it still gave them access to American consumers. All the while, patients took their medicine without question, trusting an agency that has long been considered the gold standard in drug regulation.

While specialized business publications have sometimes reported on exemptions when they happen, they’ve offered little context and few specifics.

The FDA in many ways put itself in this untenable position, forced to decide between not having enough drugs or accepting potentially dangerous ones, interviews and government records show.

For years, the agency gave companies with a history of manufacturing breakdowns approval to produce an increasingly larger share of generic drugs, allowing them to become a dominant force in American medicine with the power to disrupt lives if production lines were shuttered.

“It’s our own fault,” said former FDA inspector Peter Baker, who reported a litany of failures during inspections in India and China from 2012 to 2018. “We allowed all these players into the market who never should have been there in the first place. They grew to be monsters and now we can’t go back.”

The decisions to weaken penalties and allow banned factories to continue sending drugs to the United States were approved by Woodcock, one of the agency’s most powerful administrators. For more than two decades, she led the Center for Drug Evaluation and Research, the arm of the FDA that serves as the country’s gatekeeper for new and generic drugs.

In a series of interviews with ProPublica, Woodcock said she supported the use of exemptions “as a practical approach.”

“We had to kind of deal with the hand we were dealt,” she said.

Janet Woodcock, who served for years as the country’s top drug regulator, said she believed the drugs coming into the United States from banned factories were safe. The FDA did not routinely test the drugs for quality problems. (Jason Andrew for ProPublica)

Woodcock said she didn’t see a need to inform the public because the agency believed the drugs were safe. She said she mentioned the practice periodically in closed-door meetings with congressional staffers, but she did not provide specifics about those conversations.

After Woodcock left her post in 2020 to help lead the agency’s response to the COVID-19 pandemic, the exemptions — including those for Sun and Intas — continued under her successor, Patrizia Cavazzoni. Cavazzoni, who left the agency earlier this year and rejoined Pfizer, declined to comment.

Former FDA Commissioner Robert Califf, who led the agency when Sun and Intas received exemptions, told ProPublica that tough calls had to be made and the practice did not worry him.

The FDA did not respond to questions about who made those decisions or how the drugs were evaluated, and it declined requests for interviews with officials who currently oversee drug regulation. In an email, the agency said the exemptions are “thoroughly evaluated through a multi-disciplinary approach.”

Years after the FDA started granting exemptions, some current and former officials say they wrestle with a lingering fear that bad drugs are circulating in the United States.

“It’s not even a hypothetical,” said one senior FDA employee familiar with the exemptions, who, like others, spoke on the condition of anonymity because they were not authorized to speak publicly. “It’s not a question of if — it’s a question of how much.”

“It Was Rotten Eggs”

Although the FDA has been giving companies a way around import bans since at least 2013, the internal process was so secretive that many current and former FDA officials said they have no idea how many exemptions have been granted or for what drugs. In an email, the agency said it did not maintain a comprehensive list.

Even two high-level FDA staff members who worked on drug shortage challenges for the agency said in interviews they had never heard of the exemptions.

Congress required the FDA in 2012 to provide specific information every year about how and when the agency relaxed its rules for errant drugmakers to prevent shortages. But the FDA did not mention exemptions to import bans until 2024 — and only then in a single footnote of its 25-page report to Congress.

ProPublica uncovered the frequent use of exemptions by searching for the “import alert” list published on the FDA’s website that names factories banned from the U.S. marketplace. Because the agency publishes only a current list and doesn’t make the old ones public, the news organization used internet archives and FDA documents maintained by the data analytics company Redica Systems, ultimately compiling import alerts dating back more than a decade. The lists identify the drugs exempted from bans but provide few other details.

ProPublica reviewed scores of inspection reports and corporate documents for overseas factories and interviewed more than 200 people, including current and former officials of the FDA, to understand the little-known practice and the ongoing threat posed by the agency’s decisions.

The investigation revealed not only how many drugs received exemptions from import bans, but also how long the FDA allowed those exemptions to stay in place — in some cases for years.

The agency has removed exemptions when there is no longer a shortage concern. In those cases, the drugs are then banned along with the others at the factory. Both Sun and Intas have had drugs that lost their exemptions.

Two and a half years after the Sun factory was banned, five drugs are still exempted. Intas, whose factories were banned in 2023, currently has 24 drugs on the list. The bans themselves are removed only after companies fix the problems.

Earlier this month, the FDA went back to the Sun Pharma factory for a surprise inspection and found ongoing problems, according to a Sun filing with the Indian stock exchange and Indian media reports. The concerns focused on the way sterile drugs were made, including some of the exempted drugs still being sent to the United States, according to a person familiar with the situation who did not want to be named because they were not authorized to speak publicly.

The FDA said it put protections in place for exempted drugs: Manufacturers are required to conduct additional quality checks before they are sent to the United States. That has included extra drug-safety testing, in some cases at an independent lab, and bringing on third-party consultants to verify the results.

The agency did not provide ProPublica with the names of the third-party consultants hired by Sun and Intas. Intas declined to name its consultants.

“The odds of these drugs actually not being safe or effective is tiny because of the safeguards,” said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. “Even though the facility sucks, it’s getting tested more often and it’s having independent eyes on it.”

But current and former FDA inspectors said those safety measures require trusting the vigilance of companies that were banned, at least in part, for providing unreliable or deceptive test results to the government or failing to investigate reports about drugs with contaminants or other quality concerns.

The FDA has granted exemptions from import bans to more than 20 foreign factories despite serious quality issues. In this 2019 inspection of a factory in south-central India, inspectors found cross-contamination on drugmaking equipment. (Obtained by ProPublica. Highlighted by ProPublica.)

The FDA could have done its own routine testing of the exempted drugs but chose not to. The agency said in an email that it tests the drugs using a “risk-based approach” but would not provide ProPublica with any information about which drugs have been tested and what the results were.

Woodcock said testing was expensive and budgets were tight. She acknowledged that regularly assessing the exempted drugs for quality or safety concerns “would have enhanced our confidence … and made everyone more comfortable.”

The European Union, by contrast, requires drugs made in India and China to be checked for quality on EU soil. And the U.S. Department of Defense is conducting its own testing of more than three dozen generic medications and has already identified potency and other quality issues.

“If you don’t know about the quality of the product, why are you letting it in?” said Murray Lumpkin, the FDA’s former deputy commissioner for international programs, who left the agency in 2014 before most of the exemptions were granted.

Beyond the lack of testing, the FDA didn’t actively look for patterns of harm among the exempted drugs in its adverse event database, Woodcock and others said.

ProPublica’s analysis of that data found thousands of reports both before and after the factories were given a pass to sidestep import bans. The reports described unexpected cases of cardiac arrest, blurred vision, choking, vertigo and kidney injuries, among other issues — and in some instances identified specific concerns about how the drugs were made.

Photos from an FDA inspection show discarded and shredded records. Drugmakers are supposed to retain records like these for inspectors to review to prove that drugs going to American consumers are safe and effective. (Obtained by ProPublica)

One person who took Intas’ clonazepam, a sedative and epilepsy drug, reported getting “brain zaps” and bright blue teeth from the coating of dye on the drug. The FDA received the complaint the same month the agency exempted the drug from the import ban.

Even before the FDA exempted Intas’ antidepressant bupropion, consumers reported that it made them sick, wasn’t always effective and had an abnormal odor, which pharmacists and others say can happen when an inactive ingredient breaks down.

“It was rotten eggs,” Nari Miller, a geologist in California who took the pills in 2022 and had severe stomach pain, told ProPublica. “I opened it and smelled it when I got home and it was awful.”

Intas said it could not respond to specific complaints and that all drugs have side effects. “Intas and Accord pay attention to each and every adverse event report,” the company said, adding, “Accord and Intas are committed to continuing to bring safe and effective medicines to patients.”

In its statement, the FDA said the database is monitored weekly for new reports in general. Woodcock, however, acknowledged the reports about exempted drugs, ideally, “would be under much more scrutiny.”

Excerpt from an FDA inspection of the Sun Pharma factory that led to an import ban (Animation by Lisa Larson-Walker/ProPublica)

Watch video ➜

Too Big to Fail

Decisions made by the FDA decades ago gave rise to the use of exemptions and the risks that now confront the American public.

When new brand-name drugs come to market, they are protected by patents and exclusive sales rights that make them generally expensive. When patents expire, generic drug companies rush in to make their own versions, which are supposed to be equivalent to the brand. Generics are often far cheaper, and insurance companies typically insist that patients use them.

In the 2000s, as the cost of brand-name drugs soared, the FDA began to approve large numbers of generics. The agency, however, gave hundreds of those approvals to foreign manufacturers that had been in trouble before, companies well known to the inspectors working to stamp out safety and quality breakdowns at overseas factories, ProPublica found.

The FDA granted Sun Pharma alone more than 250 approvals for generic drugs since the late 2000s, when the company started amassing violations, records show. The agency’s decisions helped to transform the company from a local provider in India to one of the leading exporters of medications to the United States, with nearly $2 billion in annual U.S. sales.

The approvals kept coming as inspectors continued to raise concerns about manufacturing practices at the company’s factories in India, government records show.

More problems were found at a factory that Sun had acquired in Detroit, where the diabetes drug metformin was contaminated with metal scrapings. The violations were so significant that federal marshals in 2009 raided the plant and seized drugs. The company eventually shuttered the factory.

The rapid expansion of Sun and other foreign drugmakers set off new alarms among inspectors, their supervisors and advisers to Woodcock.

“In a rational system, you would have said, ‘This company is not producing properly, so let’s not approve any more of their drugs,” said William Hubbard, former FDA deputy commissioner for policy, planning and legislation. “The agency in a sense kind of let this happen.”

Ajaz Hussain, the former deputy director of an FDA office that oversaw pharmaceutical science, said that after leaving the agency and becoming a consultant, he made his concerns known in meetings with Woodcock and others.

“They can’t manufacture it. Why do you keep approving it?” Hussain recalled in an interview with ProPublica. “I said, ‘Wake up.’ … But they didn’t listen.”

Hussain in 2012 went to work for Wockhardt, one of the largest pharmaceutical companies in India, but quit eight months later after he said he told his superiors about manufacturing failures in the company’s factories.

Although FDA inspectors had reported lapses after multiple visits to Wockhardt plants between 2004 and 2012, the agency cleared the way for the company to export sedatives, antibiotics, beta blockers, painkillers and other generics to the United States, records show. Wockhardt received exemptions from import bans in 2013. The company did not respond to repeated requests for comment, but at the time, the company said it was going to quickly address the FDA’s concerns.

The FDA could have denied generic drug applications — nothing in the law prohibits the agency from saying no to companies with spotty track records. In an email, the FDA said it considers a company’s history and conducts inspections in some cases before issuing approvals.

Woodcock said the agency knew which factories were poor performers but feared being sued by companies blocked from introducing new drugs based on past behavior. Instead, she said that she tried to convince drugmakers to invest in equipment and practices that would turn out higher-quality drugs.

“We had many meetings about this, and we agonized about all these problems,” she said.

But little changed.

Shortages vs. Quality

In 2008, dozens of Americans were killed by contaminated blood thinner from China. So when Margaret Hamburg was appointed commissioner of the FDA in the aftermath of the crisis, she pressed the agency to crack down on overseas drugmakers.

Her efforts ran headlong into what would become the worst drug shortage in modern history. By 2010, cancer drugs were scarce. So were the drugs on hospital crash carts. In all, more than 200 critical medications were in short supply.

Razor-thin profit margins had limited the number of companies that were willing to make generic drugs. And the FDA’s enforcement overseas had forced some manufacturing lines to temporarily shut down, which exacerbated the problem.

LeRoy Hubley, whose wife and son died after taking a tainted generic blood thinner from China, testified before Congress in 2008. The crisis helped prompt the FDA, under Commissioner Margaret Hamburg, to ramp up inspections of overseas drugmakers. (Brendan Smialowski/Bloomberg News)

Congress lambasted the FDA for the shortages and started requiring the agency to prove every year how it was combatting the problem.

At the time, the FDA had a small team focused on shortages that operated on the edges of Woodcock’s 4,000-person Center for Drug Evaluation and Research. With the pressure on, Woodcock elevated the team in 2010 to report directly to her deputy, a move that gave those staff members a commanding voice at the highest levels of the agency, several former staffers told ProPublica.

After 16 years in top leadership roles, Woodcock was formidable enough to force a culture change. Standing 5’2” in FDA conference rooms where she had often been disregarded as the lone woman, Woodcock had fought for her status — sometimes, she said, pushed nearly to tears with frustration. The board-certified internist asserted her authority by wielding data, what she called “brute force” and the soft persuasion of an occasional gift of an orchid, picked from her garden in suburban Maryland.

Woodcock, an avid gardener, retired from the FDA last year. (Jason Andrew for ProPublica)

By 2010, Woodcock had marshalled the center into a powerhouse with great independence — in many ways, outside the reach of the political whims of the commissioners who came and went. Those who worked with her over the years said despite her approachable manner, she fiercely guarded her territory.

In the conference room next to Woodcock’s office, the drug shortage staff began to weigh in whenever the FDA’s compliance team moved to penalize wayward drugmakers because of bad inspections, according to several former FDA officials involved in the deliberations.

Sometimes the small group would decide that a factory could no longer ship drugs to the United States and would try to get other manufacturers to make more. And other times, the group determined that exemptions from import bans were the only course.

Discussions could be tense and often lasted for weeks. A former employee on the compliance team told ProPublica that they repeatedly argued to impose a total import ban on a foreign factory because they feared the drugs couldn’t be trusted. They were left feeling uncomfortable about an exemption granted anyway — for a product that they would not use themselves.

Without exemptions, Woodcock told ProPublica, the FDA might have been forced to source the drugs from a “totally unknown manufacturer, say, from China or somewhere.”

Current and former FDA officials said the concessions became a yearslong practice rather than a stopgap measure and that the protections put in place by the agency were not sufficient. They question why Woodcock and her successor didn’t do more to raise alarms with Congress or the public about the decision to rely on inadequate factories for critical drugs.

Woodcock said she thought the exemptions were a symptom of larger issues involving the drug supply that the FDA had no control over — the agency, for example, can’t force companies concerned about slim profit margins to produce generic drugs.

Two former FDA commissioners told ProPublica they knew about the practice but were not included in the decision-making.

Hamburg, who spent six years at the agency under the Obama administration, said the extent of the practice surprised her. “Had I known that it was sort of an open-ended policy, I would have been disturbed,” she said.

One of her successors, Stephen Hahn, appointed during President Donald Trump’s first term, said more people should have been involved in the decisions.

“You’re talking about a drug of questionable quality being brought into the country,” he said.

Woodcock said she did not believe she needed their input. “I didn’t think in the individual circumstances it was necessary to elevate,” she said, “because what could they do?”

Excerpt from an FDA inspection of the Sun Pharma factory that led to an import ban (Animation by Lisa Larson-Walker/ProPublica)

Watch video ➜

“We Know What Was Found”

In 2020, the billionaire founder of Sun Pharma joined a pivotal conference call with FDA compliance and investigative staff.

Dilip Shanghvi, whose father had run a wholesale drug business in Kolkata, India, started the company in the 1980s and ultimately turned Sun Pharma into one of the largest suppliers of generic drugs in the United States. On the call, Shanghvi spoke about improvements at Sun’s enormous plant in the Indian city of Halol, according to an FDA official who attended the meeting.

Among other drugs, the plant produced at least 16 sterile injectables for the U.S. market, according to a Sun email to the FDA obtained by ProPublica. Injectables are particularly dangerous if contaminated because the medication is injected directly into the body, unlike a pill that goes through the filtering of the digestive tract.

In 2018 and 2019, inspectors had reported a series of violations at the factory, and Sun had received more than 700 complaints about what appeared to be crystals or spider webs forming in one of its injectable medications, records show.

The company also had to recall more than 135,000 vials of vecuronium bromide, a muscle relaxer used during surgery, after reports that the medication contained glass particles. Sun said the defect could cause life-threatening blood clots.

On the call with the FDA, according to the agency official, Shanghvi assured the government that the Halol plant was turning out high-quality products.

Yet, when the three investigators went back to the factory that scorching morning in 2022 for the surprise inspection, it was clear within days that the FDA would have to take swift action.

Splitting up to check different parts of the plant, the inspectors quizzed workers about cleaning procedures and looked at disassembled equipment to see if it was contaminated with residue from old drugs. At one point, they spotted water leaking near areas where sterile drugs were made, an alarming observation because water can introduce contaminants capable of causing infections or even death.

Digging through company records and test results, they found more evidence of quality problems, including how managers hadn’t properly investigated a series of complaints about foreign material, specks, spots and stains in tablets.

The 2022 FDA inspection report of Sun’s Halol plant described metal particles in vials of injectable medication. (Obtained by ProPublica. Highlighted by ProPublica.)

Several FDA employees familiar with the inspection report — 23 pages of detailed violations — said they had no idea why the agency went on to exclude so many of Sun’s drugs from the subsequent import ban.

“We know what was found,” said the FDA official who attended the meeting with Shanghvi. “How could you trust [those] drugs?”

Sun did not respond to questions about the recalls or its regulatory history with the FDA. In its 2023-24 annual report, the company said, “We have a relentless focus on 24x7 compliance to ensure continuity of supplies to our customers and patients worldwide.”

The specific findings of the FDA’s latest inspection of the Sun plant conducted this month have not yet been made public, and the company did not respond to a request for comment.

To some current and former FDA officials and other experts, plugging a supply shortage with drugs that may be contaminated or ineffective is no solution at all.

“That might be helping a shortage but might be creating a new problem,” said Lumpkin, the former deputy commissioner.

Last summer, a pair of FDA investigators arrived at another manufacturing plant in India that had a bustling production line. After more than a week at the Viatris factory, they left with a familiar list of safety and quality violations.

The inspectors found that equipment wasn’t clean and managers failed to thoroughly investigate unexplained discrepancies in test results.

In a statement to ProPublica, Viatris said it immediately worked to resolve the FDA’s concerns. “Patient safety remains our primary and unwavering focus,” the company said.

Just before Christmas, the FDA banned the facility from exporting drugs.

Then the agency gave the factory a pass, and four of its drugs are still bound for the United States.

Patricia Callahan and Vidya Krishnan contributed reporting, and Alice Crites contributed research.

Medill Investigative Lab students Haajrah Gilani, Emma McNamee, Julian Andreone, Isabela Lisco, Aidan Johnstone, Megija Medne, Yiqing Wang, Phillip Powell, Gideon Pardo, Casey He, Lindsey Byman, Josh Sukoff, Kunjal Bastola, Shae Lake, Alyce Brown, Zhiyu Solstice Luo, Jessie Nguyen, Sinyi Au, Kate McQuarrie and Katherine Dailey contributed reporting.

by Brandon Roberts, Debbie Cenziper, Megan Rose and Irena Hwang

We are still reporting. If you are a current or former FDA employee or someone in the industry with information about the agency, the safety of generic drugs, or the manufacturers that make them, our team wants to hear from you. Megan Rose can be reached on Signal or WhatsApp at 202-805-4865. Debbie Cenziper can be reached on Signal or WhatsApp at 301-222-3133. You can also email us at FDA@propublica.org.

It’s been 17 years since tainted blood thinner from China injured or killed hundreds of people in the United States, and since then, contaminants and other defects have appeared in a cross section of America’s generic drugs.

To understand how risky drugs could end up in our medicine cabinets, ProPublica spent more than a year investigating the U.S. Food and Drug Administration’s oversight of foreign factories accused of violating critical quality standards. Reporters focused largely on factories in India, a key supplier of the world’s generic drugs.

The investigation exposed how the FDA, without warning the public, allowed more than 150 drugs or their ingredients into the United States over the past dozen years even though they were made at factories banned from shipping products here. The agency did not routinely test the drugs as they were circulating in the United States or actively track whether consumers had been harmed.

The FDA and several former agency officials told ProPublica they believed the medications that were exempted from import bans were safe. They said the agency required generic drugmakers to conduct additional quality checks before the drugs were sent to the United States, including extra drug-safety testing and bringing on third-party consultants to verify the results.

To conduct its analysis, Propublica used Redica Systems, a quality and regulatory intelligence company with a vast collection of agency documents, as well as the Internet Archive’s Wayback Machine, to find hundreds of “import alert” lists published by the FDA over more than 15 years. The lists identified factories barred from shipping drugs to the United States because the FDA found manufacturing violations.

In examining those lists, reporters discovered references to drugs or raw ingredients that the FDA had excluded from the bans. The exemptions were mentioned with almost no explanation, scattered throughout the often lengthy alerts.

Because the FDA does not keep a comprehensive list of drugs that have been exempted from bans over the years, ProPublica had to build one. Reporters employed two distinct methods to do this. First, ProPublica wrote code that used keyword search and pattern matching to pull drug names and manufacturing locations from the FDA alerts. Second, ProPublica used artificial intelligence to extract the same information. Results from each analysis were cross-checked, and reporters verified each of the results.

In finalizing its analysis, ProPublica counted all drugs that were exempted from each banned factory. Sometimes, the same drug was exempted from multiple factories and was added to each factory’s total. In a handful of cases, the FDA exempted different formulations of the same drug, such as a tablet, capsule or injectable. ProPublica counted those different forms as distinct drugs.

ProPublica’s list of drugs exempted from import bans could be an undercount; there is no way to know for sure without a full accounting from the FDA.

The reporting team interviewed more than 200 people, including former FDA inspectors who repeatedly reported breakdowns in drugmaking overseas and top administrators directly involved in drug safety. ProPublica also obtained troves of government and corporate documents in the United States and India and filed suit against the FDA in November after the agency said it would take as long as two years to turn over public records related to drug safety. The FDA has since begun to provide some of the requested records; the case is active in federal court in New York.

ProPublica paid Redica for access to FDA inspection records and ultimately reviewed reports spanning more than two decades.

To gauge what the FDA knew about the drugs before and after they were exempted from import bans, ProPublica drew on reports from the agency’s Adverse Event Reporting System. The reports are submitted to the FDA by consumers, health care professionals, drug companies and others and used by the agency to detect safety concerns and potential patterns of harm. Each contains information about conditions or reactions linked to drugs and, in some cases, complaints about product quality.

ProPublica identified more than 8,000 reports about the drugs excused from factorywide import bans both before and after the bans were put in place. ProPublica’s analysis included reports from 2010 to early 2025.

The FDA has cautioned that information in the reports is not verified and there may be no “causal relationship” between the drug and the adverse event. Multiple drugs are sometimes listed in a single adverse event report. ProPublica limited its analysis to cases that listed only one primary suspect drug.

Some reports don’t list specific concerns but instead reference academic studies; ProPublica excluded those reports.

To examine the FDA’s role in the growth of foreign drugmakers, ProPublica used the agency’s Orange Book, a register of drugs considered safe and effective by the FDA. The list includes approvals for both brand name and generic drugs, the dates the drugs were approved and the names of the companies that submitted the applications. ProPublica’s analysis showed that companies with troubled regulatory histories received scores of approvals to introduce generic drugs in the United States — and some went on to receive exemptions from import bans.

Journalists have been uncovering problems with generic drugs for years. Katherine Eban’s bestselling 2019 book, “Bottle of Lies,” exposed how Indian drugmakers failed to follow basic quality and safety standards and often knowingly sent shoddy drugs abroad. In 2023, a Bloomberg investigation revealed, among other things, how poisoned cough syrup made in India spread around the world. And the independent watchdog The People’s Pharmacy has raised repeated concerns about the quality of some generic drugs.

ProPublica collaborated with journalism students from Northwestern University’s Medill Investigative Lab in Washington, D.C. Haajrah Gilani, Emma McNamee, Julian Andreone, Isabela Lisco, Aidan Johnstone, Megija Medne, Yiqing Wang, Phillip Powell, Gideon Pardo, Casey He, Lindsey Byman, Josh Sukoff, Kunjal Bastola, Shae Lake, Alyce Brown, Zhiyu Solstice Luo, Jessie Nguyen, Sinyi Au, Kate McQuarrie and Katherine Dailey contributed to this report.

by Eric Umansky

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.

What Happened: A monitor appointed by a federal court has found that a New York City Police Department unit has been unjustly stopping and searching New Yorkers, almost all of them Black and Hispanic men. The report on the NYPD’s Community Response Team echoes a recent ProPublica investigation that found the unit, championed by Mayor Eric Adams, has been ridden with abuses.

The federal monitor found that while the CRT was initially created in the early days of the Adams’ administration to focus on so-called quality-of-life issues such as illegal motorbikes, its officers have more recently been “stopping, frisking, and searching unconstitutionally.”

What They Said: In a sample of body-worn camera footage, the monitor found that 41% of stops, searches, and frisks by CRT officers were unlawful, a far higher percentage than with other NYPD units. What’s more, while officers are required to document such stops, which the department then releases as public data, the report found that officers often failed to do so, and even when they did there was a “lack of meaningful review” by supervisors.

As ProPublica previously reported, that behavior goes back to at least 2023, when an NYPD audit found officers were wrongfully stopping New Yorkers and failing to log the incidents. Soon after the audit, the mayor took to Instagram. “Turning out with the team,” he wrote, showing a photo of him wearing the CRT’s signature khaki pants.

The federal monitor had other striking findings. For instance, it found that “97% of the individuals stopped, frisked, and searched were Black or Hispanic men.”

It also found, as ProPublica previously reported, that the NYPD had not been straightforward about the CRT with the monitor itself. Department officials had initially told the monitor that the CRT was just a “pilot program” that already ended, only for the monitor to later learn the team was here to stay and actually expanding.

Background: Our March investigation detailed a wide range of troubling behavior by CRT officers that alarmed NYPD leaders. In the fall of 2022, department lawyers and others warned that highlight videos of the CRT that the team posted on social media showed problematic conduct. Other incidents included a CRT commander who punched a driver, another commander who shoved a pedestrian into a car window and a third officer who drove into a motorbiker, ultimately killing him.

Over the past two years, New Yorkers have filed at least 200 complaints alleging improper use of force by CRT members, according to Civilian Complaint Review Board records. Another NYPD team with a similar size and mandate has had about half as many complaints.

Adams’ connection to CRT has been so close, former officials said, that the mayor was given private access to a live feed of the unit’s body-worn cameras. This year, he chose one of the team’s leaders, Kaz Daughtry, to be deputy mayor of public safety.

Why It Matters: The federal monitor for the NYPD was created a dozen years ago after a court found that the department had been engaging in widespread unconstitutional stop-and-frisks, a practice overwhelmingly focused on Black and Hispanic men. The seminal ruling imposed court oversight — the creation of the monitor’s office — of the country’s largest police department. The monitor in turn files regular progress reports.

The monitor’s latest report was filed with Judge Analisa Torres, who oversees the case and has the power to impose fixes. But whatever Torres does, the monitor’s findings make clear that the problems identified by the court all those years ago still persist.

Former NYPD Chief Matthew Pontillo, who wrote the 2023 audit of the CRT, said that the conduct of the team may actually be worse than what’s described in the monitor’s report, noting that the recent investigation relied on body-worn camera footage to examine officers’ conduct. In his own review, Pontillo had found that CRT officers were often not turning on their cameras to fully capture incidents.

Lawmakers and civil rights advocates have called for the CRT to be disbanded.

Response: The mayor’s office declined to answer ProPublica’s questions and instead suggested contacting the NYPD. The department has not replied to our questions.

Adams has previously defended the CRT. Asked about the unit at a mayoral press conference this spring, Adams said: “CRT is here. I support all my units. And if they don’t all stand up and do the job the way they’re supposed to do, those who don’t will be held accountable.”

The NYPD has also defended the CRT’s work and touted the unit’s confiscation of illegal motorbikes and ATVs.

by Tony Schick, Oregon Public Broadcasting

This article was produced for ProPublica’s Local Reporting Network in partnership with Oregon Public Broadcasting. Sign up for Dispatches to get our stories in your inbox every week.

Less than two years ago, the administration of President Joe Biden announced what tribal leaders hailed as an unprecedented commitment to the Native tribes whose ways of life had been devastated by federal dam-building along the Columbia River in the Pacific Northwest.

The deal, which took two years to negotiate, halted decades of lawsuits over the harm federal dams had caused to the salmon that had sustained those tribes culturally and economically for thousands of years. To enable the removal of four hydroelectric dams considered especially harmful to salmon, the government promised to invest billions of dollars in alternative energy sources to be created by the tribes.

It was a remarkable step following repeated failures by the government to uphold the tribal fishing rights it swore in treaties to preserve.

The agreement is now just another of those broken promises.

President Donald Trump signed a memorandum on Thursday pulling the federal government out of the deal. Trump’s decision halted a government-wide initiative to restore abundant salmon runs in the Columbia and Snake rivers and signaled an end to the government’s willingness to consider removing dams that blocked their free flow.

Thursday’s move drew immediate condemnation from tribes and from environmental groups that have fought to protect salmon.

“The Administration’s decision to terminate these commitments echoes the federal government’s historic pattern of broken promises to tribes,” Yakama Nation Tribal Council Chair Gerald Lewis said in a statement. “This termination will severely disrupt vital fisheries restoration efforts, eliminate certainty for hydro operations, and likely result in increased energy costs and regional instability.”

The government’s commitment to tribes, however, had been unraveling since almost when the deal was inked.

Key provisions were already languishing under Biden. After Trump won the presidency, his administration spiked most of the studies called for in the agreement, held up millions of dollars in funding and cut most of the staff working to implement salmon recovery. Biden’s promise to seriously consider the removal of dams gained little traction before it was replaced by what Trump’s energy secretary, Chris Wright, called “passionate support” for keeping them in place.

The chair of the White House task force to implement the agreement quit in April because of what he saw as Trump’s efforts to eliminate nearly everything he was working on.

“Federal agencies who were on the hook to do the work were being destroyed through untargeted, inefficient and costly purges of federal employees,” Nik Blosser, the former Columbia River Task Force chair, told ProPublica and OPB. “When I left, most things were on hold or paused — even signed contracts were on hold, which is a disgrace.”

Trump’s White House announcement called the Biden administration’s commitments “onerous” and said the president “continues to deliver on his promise to end the previous administration’s misplaced priorities and protect the livelihoods of the American people.”

“President Trump is committed to unleashing American energy dominance, reversing all executive actions that impose undue burdens on energy production and use,” the announcement read.

But the decision could also have some unintended consequences, experts say.

Trump signed an executive order in April to “restore American seafood competitiveness” but in revoking the Columbia River agreement has canceled millions of dollars to support the programs that seed the ocean with fish to catch. He signed a separate executive order on his first day in office to “unleash American energy dominance” but has now reversed a commitment, made under the Biden salmon deal, to build new sources of domestic energy. This week’s action has sent federal agencies back to court, where judges have repeatedly shackled power production at hydroelectric dams because of its impact on the endangered fish.

“It’s tempting to comment at length on the absurdity of the President’s order, including the fact that what he says he wants — stability for power generation — is in fact put more at risk by this action,” Blosser wrote in a post on LinkedIn. “Instead, I’ll look for inspiration to the mighty salmon, who don’t stop swimming upstream when they get to a waterfall.”

Back to Court

Before they began negotiating the Columbia River Basin agreement in 2021, federal agencies had been losing in court over the hydropower system for more than 20 years. Judge after judge ordered the federal government to use less water for making electricity and instead let more of the river spill through the dams’ floodgates so that fish could more safely ride the current past them.

The accord with states and tribes guaranteed up to a decade without those lawsuits. Trump canceled that.

The Bonneville Power Administration, which sells the hydroelectricity from federal dams, had more at stake than the rest of the agencies in the deal. When the government signed it, Bonneville Administrator John Hairston said it provided “operational certainty and reliability while avoiding costly, unpredictable litigation in support of our mission to provide a reliable, affordable power supply to the Pacific Northwest.”

In its most recent annual report, Bonneville credited the agreement for giving it the flexibility to increase hydropower production during times of high electricity demand, which helped stem the losses in an otherwise difficult financial year.

A major component of the agreement was the acknowledgment of the region’s dependence on hydropower and the need to build new sources of energy before removing the dams. It offered no guarantee of dam removal.

The Biden White House had pledged to help tribes develop enough renewable energy sources to replace the output of four dams on the Snake River, which salmon advocates have long wanted to remove. The administration also planned an analysis of how to meet the region’s energy needs without sacrificing salmon.

The Biden administration never followed through. Even tribally backed energy projects that were already in progress ran into bureaucratic quagmires. When Trump took office and slashed thousands of jobs from the Department of Energy, the commitment for new energy sources died too.

Proponents of Columbia River dams, including the publicly owned utilities that buy federal hydroelectricity, criticized the Biden administration for leaving them out of the negotiations that led to the agreement.

“I want to thank the President (Trump) for his decisive action to protect our dams,” Rep. Dan Newhouse, a Republican from Central Washington, said in a statement on Thursday. He said the Biden administration and “extreme environmental activists” would have threatened the reliability of the power grid and raised energy prices with dam removal.

Even critics of the Biden deal, however, acknowledge they do not want the issue to return to court, where judges’ orders have driven up electricity rates. When Bonneville can’t generate as much hydropower to sell, but still has to pay for hatcheries and habitat fixes for salmon, it has to charge utilities more for its electricity.

“I’m hoping that we avoid dam operations by injunction, because that doesn’t help anybody in the region,” said Scott Simms, executive director of the Public Power Council, a nonprofit representing utilities that purchase federal hydropower.

Earthjustice attorney Amanda Goodin, who represents the environmental advocates who signed the agreement, said the Trump administration’s actions would force a return to courts.

“The agreement formed the basis for the stay of litigation,” Goodin said, “so without the agreement there is no longer any basis for a stay.”

More Fish Will Die

The White House said that Trump’s revoking of the Columbia River deal shows that he “continues to prioritize our Nation’s energy infrastructure and use of natural resources to lower the cost of living for all Americans over speculative climate change concerns.”

Shannon Wheeler, chair of the Nez Perce Tribe, said the damage on the Columbia River is anything but speculative.

“This action tries to hide from the truth,” Wheeler said in a statement. “The Nez Perce Tribe holds a duty to speak the truth for the salmon, and the truth is that extinction of salmon populations is happening now.”

Wild salmon populations on the Columbia and its largest tributary, the Snake River, have been so sparse for decades that commercial, recreational and tribal subsistence fishing are only possible because of fish hatcheries, which raise millions of baby salmon in pens and release them into the wild when they’re old enough to swim to the ocean.

In some years, an estimated half of all the Chinook salmon commercial fishermen catch in Southeast Alaska are from Columbia River hatcheries, making them critical for “restoring American seafood competitiveness” as Trump aimed to do.

But some Columbia River hatcheries are nearly a century old. Others have been so badly underfunded that equipment failures have killed thousands of baby fish.

As ProPublica and OPB previously reported, the number of hatchery salmon surviving to adulthood is now so low that hatcheries have struggled to collect enough fish for breeding, putting future fishing seasons in jeopardy.

The Biden administration promised roughly $500 million to improve hatcheries across the Northwest. His administration never delivered it, and Trump halted all the funds before eventually canceling them with this week’s order.

Mary Lou Soscia, former Columbia River coordinator at the Environmental Protection Agency, said the administration’s dismantling of salmon recovery programs amounts to “cutting off your nose to spite your face.”

“We’re losing decades of accomplishments,” said Soscia, who spent more than 30 years at the agency.

“When the fish managers aren’t there to make real time river decisions, more fish will die,” she said. “Or the watershed restoration work will take a lot longer to happen because you won’t have funding and more fish will die.”

by Mila Koumpilova, Chalkbeat, and Jennifer Smith Richards, ProPublica

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up for Dispatches, a newsletter that spotlights wrongdoing around the country, to receive our stories in your inbox every week. To keep up with the latest education news, sign up for Chalkbeat Chicago’s free daily newsletter.

More than 4,000 students once crowded DuSable High School, then an all-Black academic powerhouse on Chicago’s South Side. Its three-story Art Deco building drew students with a full lineup of honors classes, a nationally known music program and standout sports teams.

Nat King Cole played the piano in his classroom as a DuSable student. Harold Washington, Chicago’s first Black mayor, studied there. On Friday nights, teenagers zipped through its hallways on roller skates and danced in the gymnasium.

But at the turn of the millennium, enrollment plunged as Chicago closed a massive public housing complex nearby and a growing number of Black families left the city. Amid a national infatuation with smaller high schools 20 years ago, Chicago Public Schools conducted a grant-funded experiment to chop DuSable into three separate schools sharing a campus. What remains today, after that grant money ran out, is an enormous building and, inside, two tiny schools clinging to life.

One has about 115 students and claims the north corridors. The other, with only 70 students, takes the south wings. The inoperable pool is off-limits.

Hundreds of unneeded hallway lockers hide behind decorative paper and student posters of Pakistani activist Malala Yousafzai, Supreme Court Justice Sonia Sotomayor and former first lady Michelle Obama, whose father attended in the 1950s.

The two little high schools in Bronzeville share the same entrance and sports teams, but other things are doubled: two main offices, two principals, two assistant principals, two school counselors. Even though there’s a teacher for roughly every five students, the course offerings are limited.

Chicago Public Schools operates more than 500 schools and spends about $18,700 per student to run buildings that it considers well-utilized. At the DuSable schools, the cost is closer to $50,000 a student.

The DuSable schools are emblematic of an unyielding predicament facing the district. Enrollment has shrunk. Three of every 10 of its schools sit at least half-empty, and they are costly to run.

More critically, there are 47 schools, including those inside DuSable, operating at less than one-third capacity, by the district’s measure. That’s almost twice as many severely underenrolled buildings as Chicago had in 2013, when it carried out the largest mass school closings in the country’s history, Chalkbeat and ProPublica found. The most extreme example is Frederick Douglass Academy High School, which has 28 students this year and a per-student cost of $93,000.

Many of those schools are in historic buildings that need millions of dollars in repairs.

The costs are not only financial. Students in the city’s smallest schools have fewer courses to choose from and often miss out on clubs, extracurricular activities and sports. Chicago’s underenrolled high schools are more likely to have lower graduation and college enrollment rates. They tend to struggle with chronic truancy and higher dropout rates, a ProPublica and Chalkbeat analysis found.

But officials in Chicago have chosen not to confront the problem of the city’s tiny schools. The teachers union and Chicago Mayor Brandon Johnson, who used to be an organizer and legislative liaison for the union, are quick to shut down discussion of downsizing. Widespread anger over the 2013 closures helped fuel the union’s rise to political power over the past decade; the union has also wielded the radioactive closure issue to undermine opponents, notably outgoing district CEO Pedro Martinez.

Union leaders, many community activists and some researchers say closures disrupt displaced students’ learning and harm the city’s predominantly Black and Latino neighborhoods, which were disproportionately affected by that earlier wave of closures. They argue the district needs to do much more to try revitalizing these campuses before it considers shuttering or merging them.

Helping to delay a reckoning: Since 2013, the district has operated under a series of moratoriums on closing schools, including one state lawmakers enacted with strong support from the teachers union. And a statewide school finance overhaul under former Republican Gov. Bruce Rauner increases or at least holds funding steady for districts even if enrollment declines.

Chicago has too many schools for the number of students it serves today, Martinez said in an interview with ProPublica and Chalkbeat. The district is spending too much on aging buildings, and it’s not providing a rich experience for students in many of its tiny schools, he said, adding: “They’re not having joy in that environment.”

But he said he inherited a closure moratorium and worked with school boards that had no appetite for closing or merging schools. “Our footprint is too large,” said Martinez, who leaves the district this month. “Every time somebody wants to address this issue, you see at all levels of politics, nobody wants to do it.”

He said he hopes a fully elected school board that will take over in 2027 will tackle the issue head-on, working closely with the communities it serves.

In a statement, the district noted its building utilization formula is “just one measure,” and it could overestimate available space.

The mayor’s office did not respond to requests for comment.

With public school enrollment declining across the country, a growing number of cities — Milwaukee; Denver; Flint, Michigan; Boston; San Francisco; Philadelphia — are grappling with the issue of underenrollment. Some plan to close schools.

But Chicago, the country’s fourth-largest district, operates on a larger scale: It has more students and more buildings than most other cities. The city’s school-age population, meanwhile, is on a downward trajectory, federal COVID-19 aid ran out this year and the district faces a budget deficit of more than $500 million.

And yet, Chicago “doesn’t seem to be having an honest conversation about the challenges it’s facing,” said Carrie Hahnel, a school finance researcher with the nonprofit Bellwether.

The DuSable High School building houses two smaller schools, the Bronzeville Scholastic Institute and Daniel Hale Williams Preparatory School of Medicine. Unused lockers are covered with posters and decorative crafts. (Akilah Townsend for ProPublica) “A Lack of Political Courage”

The 2013 closings of 49 Chicago elementary schools and one small high school were more than controversial. Families there felt that their communities were being torn apart as the city moved to shutter schools with long and rich histories. After protests and angry meetings, students were displaced to schools that were farther away from home. Neighborhood hubs were mothballed.

Deep distrust of Chicago Public Schools after the mass closures lingers, especially in Black neighborhoods like DuSable’s Bronzeville. University of Chicago research showed those closures set students back academically, though a small number who moved to high-performing campuses fared better. Some community groups and the teachers union in Chicago see schools as a public good; shuttering them is another mark of disinvestment.

That was the backdrop when a group of DuSable High School alumni grew concerned about dwindling enrollment at their beloved school and worried the district might target the building for closure. They approached CPS just before the pandemic with an alternative idea: Consolidate the two tiny schools at DuSable and focus classes on STEM careers.

The Bronzeville Scholastic Institute and the Daniel Hale Williams Preparatory School of Medicine would unite and revert to the name DuSable.

The alumni had no illusions that they could fully restore DuSable to what it once was. Compared to the school’s heyday, a much smaller number of school-age children live in Bronzeville today. But the alumni wanted more for the school.

The group met repeatedly with school and district leaders in DuSable’s wood-paneled social room, where trophies mark decades of athletic and musical excellence.

Officials told the group to get more input from current families at both schools — a daunting task given that the district would not provide their names or contact information. The plan fizzled out.

Hal Woods, now a policy director with the parent advocacy nonprofit Kids First Chicago, worked as the district’s school development director at the time and sat in on those meetings. He said the bottom line was that the plan smacked too much of a closure.

“We didn’t want to be seen with our fingerprints on this,” he said.

The Robert Taylor Homes — at one time the largest public housing project in the United States — once loomed over DuSable High School, as seen in these images from 1966. The complex was demolished by 2007, and DuSable High School never recovered from the loss of that student population. (Chicago Sun-Times Collection/Chicago History Museum)

Former school board President Jianan Shi, a Johnson appointee who served from 2023 to 2024, said rebuilding trust and planning for schools’ future with local communities at the helm takes time; it must begin now.

But, he said, “There’s a lack of political courage to have this conversation, and yet it’s often weaponized.”

Amid the uproar over the 2013 closings, Chicago’s then-mayor, Rahm Emanuel, vowed that his appointed school board would not close schools for five years. The state legislature then imposed a 2021 moratorium on closing Chicago schools until January of this year, part of a bill that changed the Chicago Board of Education to an elected, rather than mayor-appointed, body.

Today, Chicago has 634 schools, including 119 charter and contract schools run by outside entities, and a teachers union ally holds the mayor’s office. Last September, amid a power struggle between Johnson and Martinez, the Chicago Teachers Union publicized a facilities analysis that the district had done in late 2023, which included hypothetical scenarios for consolidating 75 schools, including Williams and Bronzeville. The union argued that even entertaining that idea was cause to fire Martinez immediately.

As the CTU pounced, Martinez pushed back, saying the district had concluded that no school would be closed while he was in charge — which he now says was really the school board’s decision. At the next school board meeting, he presented a new resolution that got unanimous support: CPS would not close any schools until 2027.

But the city’s demographic realities are not on hold. About 325,000 students enrolled this year, a drop of more than 70,000 from a decade ago. District officials project that three school years from now, there could be as few as 300,000 or, in a best-case scenario, as many as 334,000 students. Those estimates are based in part on the city’s sharply falling birth rates. Citywide, from 2011 to 2021, the number of births dropped by more than 43%.

Still, CTU leaders insist that the city is actually poised for a population turnaround. During President Donald Trump’s second administration, Chicago under Johnson can bill itself as a progressive refuge — a place that protects immigrants, abortion care, LGBTQ+ rights and access to gender-affirming care for transgender youth and adults, said Jackson Potter, vice president of the CTU.

“We are going to need to be a citadel of protection,” he said, adding that the last thing the city wants is to shutter some of its schools, then see families arriving in these neighborhoods en masse only to find limited classroom seats.

The union’s real issue with school closures, Potter said, is that Chicago has done them without enough educator and community input and has rushed them, destabilizing other nearby schools.

An influx of immigrant families allowed CPS to stabilize its enrollment and the city to notch modest population increases in the past two years after a lengthy decline. But some demographers think the Trump administration’s immigration crackdown might mean these gains are short-lived.

Jim Lewis, a senior researcher at the Great Cities Institute, a research hub at the University of Illinois Chicago, is skeptical about the possibility of an influx of school-age children in areas with shrinking schools. Some gentrifying Chicago neighborhoods have drawn new residents, but they tend to be higher earners who generally have fewer kids.

Lewis cautions that people tend to overestimate the power of schools to attract residents. Studies have shown that crumbling schools can deter families, he said. But research also suggests new programs and attractive campuses can only do so much to draw them — unless those schools come with a complete package of job opportunities, safe neighborhoods, affordable housing and more.

“I’m all for beautiful new schools,” Lewis said. “Do I think by itself it changes the demography of a place? I don’t think so.”

What to do about underenrolled schools and Chicago’s diminished school-age population is a decision for Chicago’s school board. Currently, 10 members are elected and 11 are appointed by the mayor. Next year, all will be up for election.

Some members, who said they could only speak candidly if they aren’t named, said the board must discuss solutions for tiny schools, including consolidation. But being branded “school closers” is a concern ahead of elections. Others said they’re open to discussing alternatives to school closings, including bringing health clinics or other family services into vacant parts of underenrolled schools.

“I think we have to talk about small schools as a result of historic racism, underfunding, neglect and inequity,” said member Debby Pope, a former CTU employee. A conversation is going to be essential, she said, but with a moratorium on closings in place and the possibility that the board could extend it, “I don’t think this is the moment for that conversation.”

Dozens of Chicago schools are operating at less than one-third capacity. (Taylor Glascock for ProPublica) Small Enrollment, Limited Opportunities

About 5 miles southeast of DuSable is Hirsch High School, which was one of the district’s largest school building projects when it opened in the 1920s and once dealt with severe overcrowding. It’s gotten so small now that M’Kya Craig had taken all the electives the school offered by her junior year.

She was one of roughly 100 students at Hirsch, which could enroll 1,000. She browsed the school’s limited courses and decided to take yearbook for a second time. She was bracing to take the course a third time her senior year, but Hirsch added an African American literature class.

Craig appreciated that staff at the small school got to know her well, including a counselor who helped her get into Chicago State University. But she often felt frustrated by the school’s slim course offerings and scarce extracurriculars over the years.

“We lost a lot over the years due to being a small school,” she said.

Most of the district’s underenrolled schools serve students who do not participate in Chicago’s expansive system of school choice, where high-performing students test into selective schools ranked the best in the state, and other students find their way to magnets, charters or strong neighborhood schools, often in wealthier parts of Chicago.

Many of the district’s small schools serve Chicago’s highest-needs students.

Hirsch High School on Chicago’s South Side opened in 1926 and has the capacity for 1,000 students. It currently has around 100. (Taylor Glascock for ProPublica)

At the Daniel Hale Williams Preparatory School of Medicine, one of the schools inside DuSable, junior Georgia Deaye was drawn to the school’s medical career program and loves the close-knit feel.

“The connection with teachers is way deeper than if I was at another school,” she said.

She participated in a summer internship program that Williams accesses through one of the larger district high schools and recently got her CPR certification. The most recent graduation rate at Williams was 93%, among the highest in the district. The graduating class was 14 students. There are a total of 70 students enrolled there, at a cost of $54,000 per student.

“Small schools are not always painted in a positive light,” said Williams Principal Leonetta Sanders, but the smaller environment is ideal for some students. In part because of its size, the campus hasn’t had to deal with gang problems or violence, she said.

“Safety,” she said, “is always money well spent.”

Some research has suggested that students tend to do better in smaller schools, notes Bruce Fuller, an expert at the University of California, Berkeley. But those findings apply to small-by-design campuses with healthy enrollments, not schools that have shrunk dramatically as families have moved away.

Fuller doesn’t think that student outcomes at those underenrolled schools have been studied rigorously because it would be too hard to control for factors such as the high needs of the students they tend to serve. “There’s consistent evidence that smaller can be better,” Fuller said. “But small in this lifecycle of decline is a totally different story.”

In Chicago’s tiny schools, the limitations, even at a high per-student cost, are substantial. Bronzeville Scholastic Institute, the other school inside DuSable, used to be able to teach Spanish and French but now offers Spanish only. The school once offered Advanced Placement and International Baccalaureate courses but realized it could not continue to offer both; it kept the IB program.

The schools have tried to make up for the limited course offerings by encouraging students to take online courses and dual-enrollment classes that local community colleges offer to high school students.

“You’ve got 12 kids in a class. The board is not going to pay for a calculus teacher,” Grace Dawson, who leads DuSable’s robust alumni group, said of the school district. Students are being “robbed” of opportunity, said Dawson, a former Chicago school principal.

Flush with federal COVID aid, the district added more than 7,500 new positions over the past four years even as enrollment kept declining. It also recently started guaranteeing a certain number of staff, including 10 teachers, at each school regardless of enrollment. Williams and Bronzeville, which used to share an assistant principal and a gym teacher, each hired their own. Douglass High School on the city’s West Side now has 27 employees for 28 students.

That includes six regular education teachers, six special education teachers, a school counselor, a college and career coach, a conflict resolution specialist, a restorative justice coordinator, and an assistant principal and principal. The cost to run the school is $93,000 per student.

“Is a Douglass student getting a $93,000-a-year experience? No,” said Woods of Kids First Chicago. “We can confidently say that. CPS pumps extra dollars into these schools so they can offer the bare minimum."

The district, which handles requests for comment about individual schools, did not dispute the high per-pupil price tag at Douglass. It has said its new budgeting approach gives all schools a fiscal boost regardless of size.

David Narain, who was principal at Hirsch until 2023, said the school’s smaller size allowed his staff to focus intensely on a highly mobile student body, where many students came in reading at the third or fourth grade level. But it was challenging to build a school culture on a campus with so few students.

“You try to have a homecoming, but there’s no football team,” he said. “There’s nothing to come home to.”

And Narain understands the financial tension the district faces. “The writing is on the wall,” he said. “You can’t continue to run these schools and give them all of these resources.”

Williams Preparatory School, one of the schools inside DuSable, offers students a medical career program. (Akilah Townsend for ProPublica) Old Buildings, Big Expenses

In a district with a $10 billion budget, the overall spending on staff and programs at small schools can seem negligible. But keeping aging campuses running is costly no matter how many students are there. The average Chicago school building is 85 years old; dozens of them were built before 1900.

Analysis of capital spending data by ProPublica and Chalkbeat found that since 2017, the district’s 47 severely underenrolled schools — ones that sit more than two-thirds empty — have cost more than $213 million to maintain and renovate.

The emptiest buildings account for $400 million of the district’s estimated $3.1 billion in needed critical repairs. The DuSable building alone needs $21 million in urgent repairs.

Adding to the financial uncertainty at CPS is the Trump administration’s threat to withhold federal funding from districts such as Chicago that have maintained their diversity, equity and inclusion efforts.

Education policy researcher Chad Aldeman, the former policy director of the Edunomics Lab at Georgetown University, said some closures or consolidations seem inevitable on the heels of Chicago’s massive enrollment losses. If the district doesn’t make a plan now — with community input and help to ease the transition for students — it could find itself scrambling later to reorganize in crisis mode.

“A lot of places that are closing schools are in financial distress,” Aldeman said. “They are trying to save money rather than thinking holistically.”

Closing schools can also carry steep costs. In 2013, the district spent big to add staff at schools that took in students, spruce up those schools and move furniture out of the closed buildings.

Then there’s what to do with vacant buildings. The district is still trying to sell 20 vacant schools from the 2013 closures, which it pays to maintain.

CTU leaders, who pushed to add thousands of new school staff positions in recent contract talks, have long advocated spending more to breathe new life into underenrolled schools — an invest-and-they’ll-come theory.

Potter, the CTU vice president, holds up Dyett High School — which the district closed but later reopened after a CTU-supported hunger strike in protest — as an example of a “phoenix rising from the ashes.” Its basketball team won a state title this year. Though the school is still at 58% capacity, enrollment has stabilized at roughly 500 students, a benchmark CPS has used to weigh whether a high school is big enough.

“Why would you start with a question about consolidations when you can start with a question about support?” he said.

But recent years have tested the power of added investments to boost enrollment.

In 2018, the district and teachers union jointly launched an initiative to target 20 high-poverty campuses, including Dyett, with an additional $500,000 a year. They’ve used the money to partner with a local nonprofit to offer more services for students and families.

Some of these schools have since reported parent and student engagement gains. But with a few exceptions, they have steadily lost enrollment since then, in some cases dramatically.

by ProPublica

ProPublica announced on Thursday that Adriana Pera has been hired as an engagement and tips coordinator, where she’ll work to ensure that the tips that flow into our newsroom remain secure and are routed to the appropriate reporters.

Pera was most recently an engagement producer at KPCC/LAist, where she worked on projects related to civics, democracy and education.

“Reader tips are the lifeblood of our newsroom, and we’re fortunate to have a journalist as seasoned and thoughtful as Adriana at the helm,” said Tyson Evans, chief product and brand officer.

“I’m a firm believer that journalism is better when we hear from sources and community members with direct knowledge of what’s happening,” Pera said. “I am beyond ecstatic to join ProPublica’s impressive engagement team and to uphold the accessibility, security and impact of their tips line.”