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They were the sort of disturbing discoveries that anyone taking generic medication would want to know.
At one Indian factory manufacturing drugs for the United States, pigeons infested a storage room and defecated on boxes of sterilized equipment. At another, pathogens contaminated purified water used to produce drugs. At a third, stagnant urine pooled on a bathroom floor not far from where injectable medication was made.
But when the Food and Drug Administration released the grim inspection reports and hundreds of others like them, the agency made a decision that undermined its mission to protect Americans from dangerous drugs.
Instead of sharing the names of the medications coming from the errant foreign factories, the FDA routinely blacked them out, keeping the information secret from the public. That decision prevented doctors, pharmacists and patients from knowing whether the drugs they counted on were tainted by manufacturing failures — and potentially ineffective or unsafe.
“Is there some quality issue? Is there a greater difference in potency than expected? Is there a contaminant? I don’t know,” said Dr. Donna Kirchoff, a pediatrician in Oregon who has spent hours trying to find out where certain drugs were made for patients reporting unexplained reactions.
There’s no specific requirement that the FDA block out drug names on inspection reports about foreign facilities. Still, the agency preemptively kept that information hidden, invoking a cautious interpretation of a law that requires the government to protect trade secrets.
It’s part of a decades-long pattern of discounting the interests of consumers who want to make informed choices about the drugs they take — even as 9 out of 10 prescriptions in the United States are filled with generics, many from India and China.
ProPublica previously disclosed that the FDA allowed some of the most troubled factories in India to ship drugs to U.S. consumers and kept the practice largely hidden from the public and from Congress. The agency did not proactively track whether people were being harmed as complaints poured in about pills with an abnormal taste or residue, or about patients who had experienced sudden and unexplained health concerns, including stomach pain and breathing problems.
The FDA told ProPublica that divulging drug names on its inspection reports would violate federal law that protects confidential commercial information. The agency said it only releases the information with approval from drug companies or in cases where companies have already made the details public.
Current and former officials said the restriction was imposed long ago by FDA lawyers who interpreted the law broadly because they feared being sued by drugmakers. No one could recall who made the initial decision to withhold the information or when it was made. The FDA did not respond to a request to make its general counsel available for an interview, and a half dozen former general counsels contacted by ProPublica declined to comment or did not return calls.
Officials with the generic drug lobbying group told ProPublica they have never weighed in on the redactions. A spokesperson from PhRMA, the trade group for brand-name drugmakers, did not answer a question about whether the organization had advocated for the redactions. She said that while appropriate transparency can promote public health, the FDA must protect sensitive manufacturing information.
Patient safety advocates said that should not include redacting drug names.
Credit:
Myriam Wares for ProPublica
Just two and a half years ago, FDA inspectors visited a factory in western India and discovered that spore-forming organisms had contaminated the sterile manufacturing area. The plant went on to ship its drugs to the United States anyway.
Because the names of medications were redacted on the inspection report, where they ended up, who used them and whether they caused any harm remains a mystery, at least to the public.
“The whole thing is rendered impotent if you take out the most critical piece of information, which is, ‘What drug is it?’” said former FDA Associate Commissioner Dr. Peter Lurie, who left the agency in 2017. “You’re left with this kind of vague accusation on which nobody can act because nobody has enough information to be able to do anything.”
Dr. Janet Woodcock, the longtime head of drug safety at the FDA, said in an interview with ProPublica that she favors releasing drug names but also shrugged off the usefulness of inspection reports for members of the public.
“You guys think you are like citizen scientists and you can figure out what this means and it’s just not the case,” said Woodcock, who spent nearly four decades at the FDA before retiring early last year.
Even if the FDA opted to disclose the drug names in its reports, there’s still a significant hurdle that can prevent patients from knowing if their medicine was made in a deficient factory. Labels on pill bottles often don’t list the name of the manufacturer or include a factory address, a crucial detail.
Drug companies often have multiple plants, each with its own track record. If there are no specifics on the labels, pharmacists, patients and their doctors can’t trace a drug back to the factory or to FDA reports about a plant’s safety and quality practices.
For years, the FDA resisted calls from pharmacists, lawmakers and others to require that manufacturers disclose more details on labels. Woodcock said the agency didn’t want to police thousands of companies to ensure they were providing accurate information.
“What benefit would this give you and is it worth all the effort?” she said. “We didn’t think the juice was worth the squeeze.”
Now the agency has changed course. It has asked Congress to amend the law to clearly require that labels include the names and addresses of manufacturers as well as the companies that produced a drug’s key ingredients. The FDA suggested additional details could be listed on a website.
The FDA could do even more. Current and former officials acknowledge the agency knows where every drug approved for the U.S. market is made, but does not publish that information on its website.
Instead, the agency separates the information into two different lists: one that shows factory addresses without drug names and another that shows drug names without factory addresses. There’s no easy way to connect them.
Last year, ProPublica sued the FDA in federal court to get access to the internal list of drugs and the factories that made them. The agency ultimately provided much of the information but withheld more than 6,000 addresses, saying the companies had hired contractors to make their drugs and that those names and addresses were confidential. ProPublica’s lawsuit is ongoing.
The agency holds back other critical information on drug safety as well.
When a drug is potentially contaminated by bacteria or has other significant quality problems, manufacturers are required to submit a detailed report to the FDA within three days. The reports are meant to provide an early warning about possible safety threats, but the agency doesn’t post them to its website or issue regular alerts. The only way consumers would know about a problem is by requesting a report under the Freedom of Information Act — and getting it could take weeks or longer.
In 2023, the FDA stopped releasing complaints from doctors and others that linked specific cases of harm — including hospitalizations and deaths — to drug quality concerns. The FDA had included those reports in a public database of adverse events used by researchers, doctors and others trying to assess drug safety. The agency did not respond to questions about why it made the change.
“We’ve made it almost impossible for consumers to be their own best advocate,” said Lisa Salberg, founder of a nonprofit for people with hypertrophic cardiomyopathy, a disease that causes the heart muscles to thicken. “We want our food labels to tell us exactly how much carbohydrates are in them but the things we are taking to combat diseases, we literally know nothing about.”
Credit:
Myriam Wares for ProPublica
“Kind of Like a Black Hole” One of the most widely prescribed drugs in the United States is the generic version of Lipitor, a blockbuster statin that lowers cholesterol and prevents heart attacks and strokes.
Lipitor generated billions in sales before Pfizer’s patent expired in 2011, opening the door to a patchwork of more than 20 mostly foreign drugmakers that supply their own generic, called atorvastatin.
But the boon to consumers and insurers clamoring for cheaper drugs had a little-known downside. FDA inspectors have found safety and quality violations over the years at about half of the plants that were approved to make atorvastatin, government records show.
Conditions were so worrisome at one plant in central India last year that the agency banned the factory from shipping its drugs to the United States. The FDA went on to give the plant an exemption that allowed the company to continue shipping atorvastatin here.
The millions of atorvastatin users in the U.S., however, essentially take their pills on faith, trusting the U.S. government to keep bad medicine out of the country.
Manufacturing failures can be life-threatening. Dirty equipment can contaminate drugs with glass, metal or bacteria. Poorly made drugs may not dissolve properly in the body or contain enough key ingredients. In the case of atorvastatin, the wrong dose could leave a patient with uncontrolled blood pressure.
When patients are prescribed generic drugs — typically because they are cheaper than brand names —pharmacies and insurance companies decide which ones they get. Someone taking a cancer drug, for example, could get a bottle of pills from a factory with a record of good inspections and a refill from a factory with mold, dirty water and rusted equipment.
The FDA doesn’t make it easy to know more.
In a statement, the agency said that it is reviewing the redaction process for inspection reports but did not provide specifics. One former FDA manager who dealt with the release of the reports for overseas factories said the redactions were made because revealing both the drug names and the details of what inspectors observed on production lines would give away confidential manufacturing practices.
As a result, the FDA for decades regularly defaulted to taking out all the drug names, said the former official, who did not want to be identified because they weren’t authorized to speak about agency policy by their former employer.
“It’s more important to leave what inspectors saw, so people can understand what was bad at the factory,” they said. “If you left the drug name in, you’d have to take out more of the observations.”
Woodcock and several inspectors, however, said the reports typically don’t include proprietary information about how drugs are made.
“They’re not talking about how much salt they have in there, or which buffer they use in a specific drug,” Woodcock said. “They’re talking about, ‘Did you do the test correctly? … Do you have mold in your dryer?’ That kind of thing.”
Legal experts told ProPublica that the wholesale removal of drug names was improper and that the redactions should have been made on a case-by-case basis.
In interviews, several former FDA officials now say they support releasing drug names. But Woodcock and others acknowledged they did not question the redactions while they held positions of power at the agency.
“If you’ve got lawyers telling you you can’t do this or this is putting the agency at risk or the agency will get sued and we will have our head handed to us on a platter by the courts, no one is going to say, ‘I’m willing to take that risk,’” said Dr. Mac Lumpkin, former deputy commissioner for international programs who spent more than two decades at the agency.
Meanwhile, the information that people already have ready access to — the labels on their pill bottles — can be misleading. Sometimes what appears to be the manufacturer is actually a repackager or distributor. The actual drugmaker and its factory, which is often not listed on the bottle, could be in India, China or another country.
For Kirchoff, the pediatrician in Oregon, knowing who actually makes the drugs that she prescribes would have saved five years of painstaking work. She started looking at labels when she grew worried that children with autism, anxiety and other conditions were too often declining after they switched from a brand name drug to a generic, or from one generic to another.
The labels, however, often directed her to a distributor and not to the drugmaker or factory. To this day, she said, she still doesn’t know where some drugs are coming from or whether the FDA has ever raised concerns about the factories that made them.
She now keeps a list of the drugs that she can trace to a specific manufacturer and relies on it when prescribing medication.
“Kids with neurodevelopmental disabilities can be exquisitely sensitive to little changes in medications,” Kirchoff said. “A different manufacturer can make all the difference.”
It’s not just a matter of knowing more about drug quality and safety. Pharmacists say the lack of information makes it harder for hospitals and pharmacies to keep their shelves stocked when a potential drug shortage looms.
As Hurricane Maria barreled toward Puerto Rico in 2017, ultimately causing widespread flooding and a monthslong blackout, University of Utah Hospital pharmacist Erin Fox raced to figure out which drugs were most at risk of running short. The island was home to dozens of factories that produced generic and brand-name medications.
“We know where the vulnerabilities are and we’re prioritizing,” then-FDA Commissioner Scott Gottlieb promised on Twitter at the time.
But the agency, citing confidentiality, wouldn’t release a list of drugs made in Puerto Rico, which meant Fox and others didn’t know which products to try to source from alternative suppliers.
“Nobody was ever able to get that specific list,” Fox said. “It’s kind of like a black hole.”
Ultimately, about 40 drugs were at risk of shortage after the storm.
Credit:
Myriam Wares for ProPublica
Information Denied For more than a quarter of a century, as drugs from foreign factories flowed into the U.S. market, the FDA resisted calls for transparency.
In the early 2000s, Lumpkin and others tried to persuade the FDA to provide unredacted inspection reports to regulators in Switzerland. The plan was to share information with a trusted partner under a confidentiality agreement and, working with Swiss inspectors, boost the number of investigations at high-risk factories around the world.
But agency lawyers shut that effort down, saying the FDA could not release complete inspection reports, even to other governments.
“They didn’t want to do anything that would make the industry mad,” Lumpkin said. “It was not, ‘What do we need to do for public health?’ It was, ‘What do we need to do to keep the FDA out of court?’ that took precedence.”
The agency would wait until 2017 before launching these international partnerships, which it now has with the European Union, the United Kingdom and Switzerland.
Woodcock had also pushed for change in the early 2000s, instructing her team to start building a database of factory addresses for every drug approved for use in the United States. In some cases, the information had been languishing on paper records in a storage room and the agency had no way to easily determine which facilities were producing drugs for Americans or whether they had been inspected.
“There was no information,” Woodcock said. “It was terrible. It was a mess.”
In the two decades since the agency created that database, making it possible to easily share the information with the public, the FDA chose to release drug names and their manufacturers but not specific factory addresses.
Woodcock called it a “bandwidth issue” and said she believes that releasing the information would be a reasonable step.
Another effort around that time also fell short. As the Obama administration called for transparency in government, the FDA put a searchable database of inspection information online — a move meant to give the public more details about factory practices that could “jeopardize public health.”
But the agency ultimately undermined the gesture of transparency by redacting drug names from the reports.
In 2022, a committee established by the National Academies of Sciences, Engineering, and Medicine called on the FDA to require that manufacturers publicly disclose where drugs are made. Despite that call and the transparency efforts before it, nothing much has changed.
“You can have a medication in your hand and you can literally not know the company that made it and where it was made. That’s the life of a pharmacist,” said Fox, who was on the committee along with academics and industry experts. “It’s like shopping on Amazon and all you have is the price. You really have no other information.”
In July, newly named FDA Commissioner Marty Makary promised “radical transparency” and the agency released more information about why it had denied applications for new drugs and biological products.
Nearly seven months into his tenure, the agency has yet to release detailed information about where generic drugs are being made.
Brandon Roberts of ProPublica contributed data reporting, and Melissa Dai, Isaiah Steinberg and Aidan Johnstone of the Medill Investigative Lab contributed research.
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ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.
Brandon Roberts of ProPublica contributed data reporting, and Melissa Dai, Isaiah Steinberg and Aidan Johnstone of the Medill Investigative Lab contributed research.
Brandon Roberts of ProPublica contributed data reporting, and Melissa Dai, Isaiah Steinberg and Aidan Johnstone of the Medill Investigative Lab contributed research.
