Lawmakers blast FDA drug safety oversight

WASHINGTON (Reuters) - U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of the antibiotic Ketek (Sanofi-Aventis) and some other prescription drugs on Tuesday.

At a hearing on the FDA's drug safety oversight, lawmakers said the agency stifled dissent about the risks of drugs when top managers disagreed. They cited problems with Ketek, Vioxx (Merck & Co. Inc.'s withdrawn arthritis drug) and antidepressants made by several companies.

"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 (news, bio, voting record), a Michigan Democrat who chairs a subcommittee of the House of Representatives Energy and Commerce.

"One must ask, if the FDA is not protecting its client, the American people, whose interest is being protected?" Stupak said.

Iowa Republican Sen. Charles Grassley (news, bio, voting record), a vocal FDA critic, told the committee that "scientific dissent is discouraged, quashed and sometimes muzzled" inside the agency and "there's widespread fear of retaliation for speaking up about problems."

Congress is considering legislation to strengthen the FDA's oversight of drug side effects.

That's a tough role - the FDA is criticized for over-caution when drugs which might save people's lives are caught up in the testing process for years, and criticized for being lax or for being prey to special interests when they approve a drug later found to have harmful side-effects.

Yes, it is a tough position, but the FDA has been receiving money from the pharmaceutical companies since 1992, and it creates a muddied atmosphere of conflict of interest. Personal financial conflict of interest by the scientists reviewing new drugs has also been an issue, including the former head of the FDA being fined (he also apparently lied in his financial reports and to congress, but that's another story).

Some examples of "issues":

http://medgadget.com/archives/2007/01/former_fda_chie.html
Former FDA Chief To Be Fined for Conflict of Interest

http://www.latimes.com/news/nationworld/nation/la-na-fda19dec19,0,3272586,full.story
Family tie helps win FDA contract

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=42963
Prescription Drugs | Critics Question Proposal To Increase User Fees Paid to FDA by Pharmaceutical Companies

"Provisions in the fiscal year 2008 budget proposal released last week by President Bush that would increase user fees paid to FDA would "give business too much influence" over the agency, according to some critics, USA Today reports (Schmit, USA Today, 2/14). Under the 1992 Prescription Drug User Fee Act, pharmaceutical companies agreed to pay user fees in exchange for reviews of new medications in 12 months or less. Pharmaceutical companies pay user fees when they file applications for new medications based on the number of manufacturing facilities that they operate and the number of products that they market in the U.S. The law will expire this year without reauthorization by Congress (Kaiser Daily Health Policy Report, 1/12)."

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