Committee weighs bill to fund accelerated drug review

September 23, 1992|By Federal Filings News

WASHINGTON -- The Senate Labor and Human Resources Committee mulled yesterday the approval of a bill levying fees on pharmaceutical companies in order to help fund the acceleration of the Food and Drug Administration's cumbersome prescription drug review process.

The bill would assess more than $350 million in "user fees" on the industry over the next five years. Those fees are earmarked for cutting FDA drug review time in half -- to six months -- for priority applications for breakthrough drugs and 12 months for standard applications.

The extra funding would cover 600 new medical reviewers at the FDA, which, because of the government's attempt to cut the deficit, has been faced with squeezed resources and application backlogs at a time when new biological discoveries are leading to more drug products.

Members of the pharmaceutical and biotechnology industries testified yesterday in favor of the legislation being proposed by Labor Committee Chairman Edward Kennedy, D-Mass., and Republican committee leader Orrin Hatch of Utah. They argued that the added fees would be less detrimental to drug companies than FDA delays.

FDA Commissioner David Kessler said the legislation is important because, "We are on the verge of tremendous new medical breakthroughs." He cited new drugs being developed, including treatments for Alzheimer's disease, diabetes, multiple sclerosis and Parkinson's disease.

Mark Skaletsky, chairman of Cambridge, Mass.-based Enzytech Inc., noted that any application-based fees could drain the financial resources of biotech companies that don't yet have approved products to generate revenue, strangling their research and development efforts.

But he went on to say that his industry has concluded that FDA delays would hurt them more.

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