- News Report Headlines2025-06-24
- Threat in your medicine cabinet: The FDA’s gamble on America’s drugs
By Debbie Cenziper, Megan Rose, Brandon Roberts and Irena Hwang, ProPublica
This story was originally published by ProPublica, is a nonprofit newsroom that investigates abuses of power. Sign up to receive its biggest stories as soon as they’re published.
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.
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.
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?”
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.
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 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.
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.”
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 manuf
National Chung Cheng University of Crime Research Center - Education Center for Prevention of Drug Abuse
No.168, Sec. 1, University Rd., Minhsiung, Chiayi 621301, Taiwan 05 - 2724151 deptcrc@ccu.edu.tw