An FDA whistleblower says there is a “culture of approval” that allows dangerous drugs to make it to the market far too quickly.
Doctor David Ross, a former drug reviewer at the FDA, told a panel that they push to “find ways” to quickly get new drugs to the market without concern for the consumer.
Ross says the FDA approved Ketek (an antibiotic) although they knew it could potentially kill people from liver damage and that the drug maker had submitted fabricated data.
Panel chairman Bart Stupak expressed concern about the Prescription Drug User Fee Act, which requires that new drugs be made available to consumers quickly. He says it’s “greatly compromised” the F-D-A’s ability to assure drug safety.