Tuesday, July 29, 2008


New law aims to distance the FDA from the drug industry

Jeanne Lenzer

New York

Legislation aimed at ending the close relationship between the US Food and Drug Administration and the drug industry was introduced last week in the House of Representatives by Congressman Maurice Hinchey (Democrat) of New York.

The Food and Drug Administration Improvement Act 2005 has been endorsed by the Center for Science in the Public Interest in Washington, DC, a non-profit education and advocacy organisation. Merrill Goozner, director of the centre's integrity in science project, said it was "exactly what is needed to restore public confidence in the FDA."

The bill includes several provisions aimed at ending financial conflicts of interest. Drug companies would still be expected to pay fees but they would be paid to a general fund of the US Treasury. The bill prohibits the FDA from negotiating with drug companies about how it uses funds and it "terminates all previous agreements between FDA and such companies."

The bill would also prohibit scientists with financial conflicts of interest from sitting on FDA advisory panels.

Furthermore, it would establish a separate centre for post-market drug safety and effectiveness, so that "different doctors and scientists than the ones who approve a drug will monitor its safety once it hits the market."

If passed, the bill would overturn provisions of the Prescription Drug Users Fee Act (PDUFA), first passed in 1992, which established a schedule of payments by the drug industry to the FDA.

Mr Hinchey said, "[PDUFA] was initiated during the first Bush administration, allegedly to speed up the approval of drugs, but what it did—and what I think they knew it would do—was to establish a close relationship between the regulatory agency and the industry it is supposed to regulate. Right now, almost 50% of the FDA drug budget is funded by the drug industry.

"And the ridiculous part is that the FDA has to negotiate with drug companies about how they use this money. It creates a relationship that is contrary to the whole idea of what the FDA is supposed to be."

The bill would redirect drug company fees to a general fund of the US Treasury and would create mandatory funding levels to support the FDA. It would also prohibit the FDA from negotiating with drug companies and "terminates all previous agreements reached between FDA and such companies."

Other provisions of the bill would empower the FDA to mandate post-marketing studies, demand label changes, and impose penalties of up to $50m (£27m; {euro}39m) against companies that violate FDA drug regulations.

A controversial legal stance at the FDA known as "pre-emption" (bmj.com; 8 Jan 2005, News Extra) that was introduced by the former chief counsel to the FDA, Daniel Troy, would also be reversed under the bill. Mr Troy argued that manufacturers of drugs that were approved by the FDA could not be held liable for adverse outcomes unless the company committed outright fraud.

The FDA does not comment on legislation. The Pharmaceutical Manufacturers and Research Association had not responded to requests for interviews at the time the BMJ went to press.

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