S. 830 Still A Major Threat To Public Health PDUFA Reauthorization Still Threatened
The Senate Labor and Human Resources Committee postponed yesterday a mark-up of S. 830, the Food and Drug Administration Modernization and Accountability Act of 1997. Final committee consideration of S. 830 has been rescheduled for Wednesday, June 18, 1997.
Senator James Jeffords (R-VT), Chairman of the Labor Committee, recently introduced a new version of the "reform" bill, but nothing has changed to make it better for consumers and patients. The bill still includes provisions that will:
- Lower the effectiveness standard for new drugs allowing fewer studies to prove medicines safe and effective;
- Allow approvals for new drug indications based solely on anecdotal evidence and not scientific studies;
- Allow marketing approval of new drugs based on findings that show an improvement in physical signs of a disease (like shifts in CD4 or viral load counts) but not necessarily how a patient feels, functions, or survives without any enforceable mechanism to confirm these findings through additional clinical trials;
- Eliminate or weaken most regulatory protections against unsafe medical devices by allowing manufacturers to select and pay for-profit reviewers to certify that their products are safe and effective and let companies make what they consider to be "minor" changes in the manufacturing process without notifying the FDA.
Unfortunately, these "reform" measures are still tied to the reauthorization of the Prescription Drug User Fee Act (PDUFA), a program designed to help speed up the drug approval process by charging fees on new drug applications. It is important that PDUFA be reauthorized without any damaging "reform" measures to
ensure that new drugs make it to market faster while maintaining their safety and effectiveness.
AIDS ACTION : Don't let Congress compromise on safety and effectiveness. Don't let Congress put the public health at risk.
Call and write your Senator on the Labor Committee (see June 5 Alert "Senate Again to Consider FDA 'Reform'" for the target list) and tell them:Advertisement
- Support strong post-market clinical trial requirements for drugs; and
- Oppose lower effectiveness standards for drug approval.
For more information, contact:
(202) 986-1300 Ext. 3062
AIDS Action Council
1875 Connecticut Avenue NW #700
Washington DC 20009
202-986-1300, extension 3053