Hmmmmm. Wonder what impact this has on the approval process. - SM
http://www.nytimes.com/2002/01/26/business/26DRUG.html
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January 26, 2002 Drug Makers Willing to Pay F.D.A. Fees
By BLOOMBERG NEWS
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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