Magazine article Drug Topics

Not Good Enough: Some Feel FDA's Easing of Off-Label Rules Still Falls Short

Magazine article Drug Topics

Not Good Enough: Some Feel FDA's Easing of Off-Label Rules Still Falls Short

Article excerpt

Some feel

FDA's easing

of off-label

rules still

falls short

Too little, too late. That's how critics of the Food & Drug Administration view the agency's proposal to ease its restrictions against promoting offlabel uses. Under recently released draft policy guidelines, the FDA would let pharmaceutical manufacturers distribute peer-reviewed journal articles and medical textbooks that contain incidental, nonhighlighted references to off-label uses. But the plan so far has failed to attract enthusiastic support.

"The FDA's action indicates that it continues to believe that doctors cannot be trusted to make appropriate use of truthful medical information," said Richard A. Samp, chief counsel of the Washington Legal Foundation, a probusiness public interest group that previously had sued FDA over the off-label use policy. While commending the agency for "demonstrating greater flexibility," Jeff Trewitt, a spokesman for the Pharmaceutical Research & Manufacturers Association, said the proposal "still falls far short of what is necessary to keep physicians and other health-care professionals adequately informed." Formal comments from PhRMA and other interested parties were scheduled to be filed with FDA after midmonth.

What drugmakers legally can say about non-FDA-approved uses of their products is a key issue in the FDA reform debate, still simmering on Capitol Hill. Since the Republicans seized control of the House and Senate last year, the FDA has taken a number of internal steps aimed at defusing some longstanding objections to its policies. As part of Vice President Albert Gore's "Reinventing Government" initiative, for example, the FDA pledged to scrap thousands of pages of rules, regulate biotechnology drugs the same way it does other medicines, and eliminate special regulations for antibiotics and insulin.

But these and other self-reforms are not mollifying critics. "Reform of the FDA cannot be left up to the FDA," said Rep. Thomas Bliley (R, Va.), last month. Bliley, chairman of the House Commerce Committee, which is drafting sweeping reform legislation, said he was not "interested in 'reinventing' the FDA and neither are my colleagues." He vowed that there would be a "comprehensive package of reforms" ready for a vote in the House later this year and suggested it might include "reorganizing the agency or even splitting it up, if that's what's called for."

As for FDA's off-label use policy, Bliley also was critical. …

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