Is Your Medication Made In A Contaminated Factory?

They were the sort of disturbing discoveries that anyone taking generic medication would want to know.

This article was written by Debbie Cenziper and originally published by ProPublica.

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.

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.”

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