Drug Makers Willing to Pay F.D.A. Fees

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Hmmmmm.  Wonder what impact this has on the approval process. - SM

 

http://www.nytimes.com/2002/01/26/business/26DRUG.html

 

January 26, 2002

Drug Makers Willing to Pay F.D.A. Fees

By BLOOMBERG NEWS

 

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WASHINGTON, Jan. 25 (Bloomberg News) — Drug makers signaled a willingness today to help pay for the Food and Drug Administration to expand policing of the industry, an industry official said.

Drug makers are negotiating the renewal of a system, set up in 1992, under which the companies pay fees to the F.D.A. in exchange for improved medicine approval times. That program allows the F.D.A. to use the extra cash only to hire staff members to review drug proposals.

The use of industry fees to monitor reporting of harsh side effects of approved medicines and direct-to- consumer advertising is "on the table for discussion" in talks with the F.D.A., said Russel Bantham, general counsel for the Pharmaceutical Research and Manufacturers of America, a trade group. The group previously contended that Congress should appropriate more tax money for drug-monitoring programs.

The F.D.A. accelerated average review times for new medicines to less than a year in 1999, from almost two years in 1990. The same law required drug makers to submit fees with their applications.

Application reviews slowed in 2000 for the first time in seven years, raising complaints from drug makers.

 

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