Last year's user fee legislation, sponsored by Senators EdwardKennedy, D-Mass., and Orrin Hatch, R-Utah, would provide FDAwith the funds needed to unclog the drug pipeline. By oneestimate, without the legislation, it could have taken up to 13years to process all pending biotech drug applications.

But money is needed to jump-start the program while FDAwaits for user fees to begin to flow. In a hearing last nightbefore a subcommittee of the House Appropriations Committee,Richard Godown, representing the biotechnology tradeorganizations, and Gerald Mossinghoff, head of thePharmaceutical Manufacturers Association, urged committeeChairman Richard Durbin, D-Il., to free $36 million for fiscal1993, an amount that had been contemplated in the Act.

"Our industry had to achieve an effective consensus with theCongress and the FDA on this issue," said Godown. "We areproud of that effort and pleased with the result, whichrepresents what we believe to be an historic public-privatepartnership to enhance public health in this country."

Mossinghoff emphasized that the new drugs would save muchmore than Congress would spend on the user fee program,citing "328 medicines in testing for just eight currently uncureddiseases: osteoporosis, diabetes, stroke, depression, arthritis,Alzheimer's, cancer, and cardiovascular diseases. The cost ofthese eight diseases amounts to over $400 billion a year."

Durbin left little doubt that he would support theappropriation. In fact, part of the purpose of the hearing hadbeen to look into extending the user fee idea to foods andmedical devices -- an idea that was strongly resisted byrepresentatives of those industries.

Earlier, committee members had warmly received AbbeyMeyers, executive director of the National Organization for RareDisorders, who had requested an additional $3 million to fund"academic researchers and small companies" interested indeveloping orphan drugs. This would raise the totalappropriation for orphan drugs to $15 million, of which FDAwould receive 25 percent for user fees.

Durbin assured her that he would go to bat for orphan drugs."The orphan drug program was started by this committee," hetold Meyers. "I'm glad you came to tell us about it."

-- David C. Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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