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Pharmaceuticals pay fda more for speedy approvals { November 22 2006 }

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   http://www.boston.com/business/globe/articles/2006/11/22/drug_makers_reportedly_cut_deal_with_fda_on_fees/

http://www.boston.com/business/globe/articles/2006/11/22/drug_makers_reportedly_cut_deal_with_fda_on_fees/

Drug makers reportedly cut deal with FDA on fees
By Bloomberg News | November 22, 2006

WASHINGTON -- Drug makers agreed to a 29 percent increase in payments to U S regulators to ensure speedy approvals of new medicines and step up safety monitoring, according to a person familiar with the accord.

Representatives of drug makers and their trade associations also agreed for the first time to pay fees to have their consumer television commercials reviewed in advance by the U S Food and Drug Administration, the person said. The terms are spelled out in agreements between the industry and the FDA that are subject to approval by the Bush administration and Congress.

The FDA wants to use some of the extra money to step up safety monitoring of drugs after they go into use. Democrats and Republicans in Congress criticized the agency's performance after antidepressants were linked to increased risk of suicide and painkillers such as Merck & Co.'s withdrawn Vioxx were tied to heart attacks and strokes. The new fees would be part of the renewal of a 14-year-old law that expires next year.

The drug maker payments make it impossible for the FDA to be a "vigilant regulatory agency," said Sidney Wolfe, director of the health research group of the consumer group Public Citizen, an FDA critic . "The whole thing needs to be repealed."

Public interest groups including Public Citizen say the FDA's $1.88 billion budget is inadequate for the agency to provide sufficient oversight of drugs. The FDA also regulates medical devices, food, and cosmetics.

Payments to the FDA for new-medicine applications would increase by at least $87.3 million to $392.8 million in the fiscal year starting next October, the person said. About $30 million of the increase would be spent to upgrade the agency's monitoring of drug safety, according to this source.

The FDA hopes to use some of the funds to improve detection and evaluation of harmful side effects after drugs are on the market, the person familiar with the agreement said.

Copyright 2006 The New York Times Company


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