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FDA Seeks More Regulatory Authority

March 1, 2005
The Food and Drug Administration, under fire after a series of agency-approved drugs were later suspected of causing severe health problems, has told Congress it needs more authority to warn the public.

A key FDA regulator says the agency should be allowed to write warning labels on drugs, instead of negotiating the wording with the manufacturer.

In testimony before the Senate Health, Education, Labor and Pensions Committee, Sandra Kweder, deputy director of the FDA Office of New Drugs, pointed to the negotiations with Merck over the warning label on Vioxx.

She said the negotiations took longer than most, lasting a year or more, and that the FDA and Merck had difficulty agreeing on the wording.

It wasn't until 2002 that Merck finally added a warning to Vioxx concerning heart risks. Then, in September last year, Merck abruptly withdrew Vioxx from the market after evidence began to mount that Vioxx poses increased risks of heart attack and stroke.

Kweder said allowing FDA to unilaterally draft a warning label and apply it to a drug would be helpful "under extreme circumstances," but would not be a weapon of choice for regulators.

The FDA is currently deciding whether to allow Vioxx's return to the market, as recommended last month by an advisory panel.

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