FDA reform - Congress "comfortably obliged" to Big Pharma

Insider's favourite newspaper The Newark Star-Ledger has examined how, nearly two years after the withdrawal of Merck's COX-2 inhibitor Vioxx due to safety concerns, neither the Senate nor the House has "taken any legislative action on drug safety, and neither is likely to do so any time soon."

At the time of the Vioxx withdrawal, drug safety was the subject of congressional hearings, and FDA faced "harsh criticism," the Star-Ledger reports.

Senate Finance Committee Chair Chuck Grassley (R-Iowa) last year introduced legislation that would create an independent drug safety division within FDA, which would have the power to restrict distribution, require label changes or withdraw agency approval for drugs believed to have safety issues. The bill also would give FDA the authority to require pharmaceutical companies to create a registry of all clinical trials and conduct additional trials when safety concerns arise for FDA-approved drugs.

Rep. Maurice Hinchey (D-N.Y.) introduced a similar bill in the House. In addition, Senate Health, Education, Labor and Pensions Committee Chair Mike Enzi (R-Wyo.) and ranking member Edward Kennedy (D-Mass.) are drafting their own bill that would address FDA oversight.

However, lawmakers and officials from consumer and industry groups "predict the drug safety issue won't come to the front burner until at least a year from now, when Congress must renew the law authorizing payment of pharmaceutical company user fees to the FDA to cover the costs of drug reviews," the Star-Ledger reports.

Hinchey said, "This Congress has refused to consider any of the proposals to reform the FDA, and that refusal comes about because members are comfortably obliged to the pharmaceutical industry."

Insider's view: The fish rots from the head! FDA reform is long overdue, but it wont happen until after the elections.

In the meantime, Big Pharma is making hay whilst the sun shines.