December 1, 2008
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“Mother of All” F.D.A. Reauthorization Bills Passes House

Date: 09-20-2007
Type: public policy
Category: Health & Wellness
Source: The New York Times

The House passed legislation that is expected to give federal drug regulators significantly more money and power to ensure the safety of the nation’s drug supply.

Senate passage is expected, and President Bush will probably sign the measure quickly—all part of a race to forestall dismissal notices Friday for some 2,000 employees of the Food and Drug Administration.

The legislation was welcomed by both industry and consumer groups, who all found something to trumpet in the mammoth bill.

The bill combined several pieces of legislation governing drug industry user fees, new rules involving the disclosure of clinical trial results, money for studies of older medicines, incentives for tests in children, and even the conflicts of interest of drug agency advisers.

“It is the mother of all F.D.A. reauthorization bills,” said Dan Troy, a former general counsel for the drug agency who represents drug makers.

Even with all of these provisions, however, the bill does not address every controversial issue involving the agency. Cancer patients marched outside F.D.A. offices to protest the agency’s decision not to approve Provenge, a drug for prostate cancer. The legislation passed does nothing to address calls by some patient advocacy groups for the agency to allow the sale of some drugs while they are still being researched. Nor does the bill do much about concern over the safety of imported foods beyond creating a registry of adulterated foods and a statement that Congress “should work to develop a comprehensive response to the issue of food safety.”

Organization:
The New York Times
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