Skip Navigation



Journal of the National Cancer Institute Advance Access published online on July 10, 2007
JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djm071
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow All Versions of this Article:
99/14/1072    most recent
djm071v1
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Request Permissions
Google Scholar
Right arrow Articles by Finkelstein, J.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Finkelstein, J.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© Oxford University Press 2007.

NEWS

FDA User Fee Law Poised for Passage in Congress but Not Without Stirring Up Controversy

Joel Finkelstein

The first 150 words of the full text of this article appear below.

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, . . . [Full Text of this Article]

The Means, But Not the Will?

First Speed, Now Safety


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?