Drug User Fee Act must prioritize safety, FDA independence


Monday, Nov. 14, 2005

Drug User Fee Act Must Prioritize Safety, Effectiveness
and Independence as Part of Approval Process, FDA Told

Consumers Union outlines proposals for public hearing on PDUFA

(Washington, D.C.) – Consumers Union today outlined for the FDA major reforms of the Prescription Drug User Fee Act to bring increased emphasis to drug safety, improve the FDA’s independence from the drug industry, and help consumers understand what medical treatments are truly effective.
Bill Vaughan, senior policy analyst, submitted the testimony as part of a public meeting on the reauthorization of PDUFA, the act that requires the pharmaceutical industry to help fund the drug-approval process. Tying industry funding to specific drug-approval goals undermines the agency’s independence, Vaughan said.
“While there are some benefits from the FDA getting increased funds to speed review of new, life-saving drugs, we believe the overall result of this law has been to undercut the independence and objectivity of the agency due to its reliance on industry funding,” Vaughan said.
“To help ensure drug safety and effectiveness are priorities, the industry fees should be transferred to the FDA with no strings attached,” Vaughan said.
Consumers Union supports these primary changes to improve PDUFA:
• The fees collected under PDUFA should not be tied to the overly-restrictive performance goals that rush the approval of potentially unsafe drugs and limit follow-up safety efforts
• If PDUFA continues to be a primary funding mechanism, more money should be collected in order to allow the FDA to fulfill its mission.
• Funds should be used by the agency to improve post-approval monitoring and safety, conduct prior review of advertising and marketing materials, and ensure that safety studies are completed to help consumers fully understand the comparative value of approved drugs.
To read the complete comments and recommendations, click here.
Contact: Bill Vaughan, Susan Herold, 202-462-6262 -30-