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Is Your Medication Made in a Contaminated Factory? The FDA Won’t Tell You.

4 127
yesterday

by Debbie Cenziper and Megan Rose

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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.

(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........

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