Healthy Skepticism Library item: 8000

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Tanne JH.
FDA proposes higher fees for drug approvals to cover postmarketing surveillance
BMJ 2007 Jan 27; 334:(7586):177
http://www.bmj.com/cgi/content/full/334/7586/177-b

Abstract:

The US Food and Drug Administration has agreed with pharmaceutical manufacturers on an almost 30% increase in the “user fees” that drug makers pay to the FDA to expedite approval of new drugs. The FDA has also consulted patient advocates, consumer groups, health professionals, and academic researchers about the new rules.

User fees are annual fees paid by pharmaceutical manufacturers. The FDA wants them to increase by $87.4m to $392.8m (£199.0m; 303.7m). The FDA now gets more than half of its funding from user fees.

The agency will hold a public meeting in Washington, DC, on 16 February to hear comments and will then ask Congress to approve the new rules.

The FDA says the largest portion of the new fees-$29.3m-will help it increase postmarketing surveillance of newly approved drugs beyond the current three years. The agency has been criticised for not detecting the cardiovascular risks of COX 2 (cyclo-oxygenase-2) . . .