Healthy Skepticism Library item: 11280

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

Finkelstein J.
FDA user fee law poised for passage in Congress but not without stirring up controversy.
J Natl Cancer Inst 2007 Jul 18; 99:(14):1072-3
http://jnci.oxfordjournals.org/cgi/content/extract/99/14/1072

Abstract:

The fourth iteration of the 1992 law that allows the U.S. Food and Drug Administration to levy user fees on drug companies contains several reforms that could create a major change in how the agency monitors the safety of new drugs after they enter the market.

Lawmakers are using reauthorization of the Prescription Drug User Fee Act (PDUFA) to overhaul the agency’s authorities and responsibilities for ensuring drug safety. The legislation would allow the FDA to collect $393 million in fees annually from the industry starting in 2008. That is up from $305 million this year and includes another $30 million to fund the agency’s postmarketing drug safety programs. The bill passed the Senate on May 9. A companion bill has been introduced in the House.

“The resources and additional staffing made possible by the fees charged by the FDA have enabled the agency to review new medicines more efficiently, . . .

The Means, But Not the Will?

First Speed, Now Safety

Keywords:
Publication Types: News MeSH Terms: Drug Industry/economics* Drug Industry/legislation & jurisprudence* Federal Government* United States United States Food and Drug Administration/legislation & jurisprudence*