Critics slam FDA on drug safety

At a House Energy and Commerce subcommittee hearing yesterday, ex-FDA staffers and influential Cleveland Clinic cardiologist Dr. Steven Nissen (photo [1]) criticized the FDA for having improper ties with drug and device makers, which they claim has caused the agency to overlook safety concerns with new drugs. The recent problems with Ketek [2], several antidepressants [2] and, of course, Vioxx [3]has led many to question how well the FDA monitors drug safety both before after approval. "With each of these drugs, it appears that the FDA is not seriously questioning whether the risks outweigh the benefits of the new drug," said Rep. Bart Stupak (D-MI).The witnesses claim that in some cases the agency pressured experts to change their opinions on the safety of drug in order to appease drug makers, and pushed for fast approval of dugs despite safety concerns.

"The FDA...needs an overhaul to make the agency more transparent, more forthcoming, and more independent minded," noted Rep. Charles Grassley (R-IA), a vocal critic [4] of the agency. The FDA was not present to testify but defended itself in a statement. Congress is considering passing legislation that would increase the FDA's oversight of drug side effects.

- check out this Cleveland Plain Dealer report [5] for more on the testimony

ALSO: A case working its way through the legal system may end up forcing the FDA to give super-sick patients the right to buy and use unapproved experimental drugs. Report [6]

Related Articles:
GAO cites FDA on post-market safety failure. Report [7]
Showdown looms in Washington over FDA reforms. Report [8]
FDA offers safety reforms to skeptical lawmakers. Report [9]