Monday, April 9, 2007

SKAPP on User Fees in the FDA

SKAPP issued an open letter [PDF] a few weeks ago advocating for abandonment or changes in the user fee-based system set up for drug review at the FDA.

“User fees may appear to save the taxpayers money, but at an unacceptable cost to public health,” the letter warns, citing findings of a panel of experts recently convened by the Institute of Medicine (IOM) to address drug safety at the FDA.  Four of the letter’s signers served on that IOM panel, and six signers are former top staff of FDA or the Department of Health and Human Services.

Glancing through the signatories, I recognize at least four or five as having served as plaintiffs' experts in litigation involving the FDA.

(And as a reminder, I do a small amount of work for pharmaceutical companies.)

http://lawprofessors.typepad.com/tortsprof/2007/04/skapp_on_user_f.html

Products Liability | Permalink

TrackBack URL for this entry:

http://www.typepad.com/services/trackback/6a00d8341bfae553ef00d834f4d57153ef

Listed below are links to weblogs that reference SKAPP on User Fees in the FDA:

Comments

"Major support for SKAPP is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation, with additional support from the Alice Hamilton Fund and the Bauman Foundation."

Posted by: Ted | Apr 9, 2007 5:28:37 AM

As near as I can tell, SKAPP is an organization devoted to undermining Daubert gatekeeping. I understand it was created as a by product of the Breast Implant litigation, but who/what is the driving force and who provides the philosophical leadership?

Posted by: Cliff Hutchinson | Jul 6, 2009 3:15:40 PM

Post a comment