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.
Hellbound and Down 