Despite concluding that a drug research lab’s violations “were so ‘egregious,’ and pervasive that studies conducted there between April 2005 and August 2009 might be worthless,” the FDA didn’t pull the drugs tested there from the market, according to a ProPublica piece by Rob Garver and Charles Seife.
The FDA is refusing to release information about those drugs, saying that “We believe that this did not rise to the level where the public should be notified.”
A statement from the agency said, “The issue is not a lack of transparency but rather the difficulty of explaining why the problems we identified at Cetero, which on their face would appear to be highly significant in terms of patient risk, fortunately were not.”
About 100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston’s tainted tests.
The FDA has required drug makers to re-test, re-analyze or audit many of the tests run by the lab but then failed to enforce the deadlines. “For its part, the FDA has finished its review of just 21 of the 53 submissions it has received, raising the possibility that patients are taking medications today that the agency might pull off the market tomorrow.”
The FDA will not reveal what drugs are being re-assessed, nor would it release the risk assessment or the 21 reviews it has conducted. David Kessler, M.D., former head of the agency, said the FDA’s review should be transparent.
ProPublica was able to use regulatory filings, scientific studies and lawsuitsto identify a few of the drugs.