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Reporting Highlights
- Hidden Drug Names: For decades, the FDA has blacked out the names of generic drugs on inspection reports for foreign factories that were found to have safety and quality violations.
- Patients in the Dark: The practice has prevented patients, doctors, and pharmacists from knowing whether manufacturing failures have made medications ineffective or unsafe.
- Pill Bottle Mysteries: Consumers are limited in what they can learn about the quality of their drugs because labels on pill bottles often don’t list the manufacturer or the factory’s address.
These highlights were written by the reporters and editors who worked on this story.
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.