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News & Analysis | REG•WATCH Blog | Press Room
Friday, May 11, 2007
Senate FDA Reform Bill: The Nuts and Bolts
Wednesday, the Senate voted 93-1 to pass S.1082, The Food and Drug Administration Revitalization Act. The two primary aims of the legislation are to renew the Prescription Drug User Fee Act and to generally strengthen the regulatory authority of the FDA.
Renewing PDUFA
The legislation would renew and expand (by about 33 percent) the FDA's user fee program whereby pharmaceutical companies pay for safety reviews of new drugs. The current PDUFA program is set to expire Sept. 30. If PDUFA renewal is not signed into law by July, FDA has said it will begin warning drug-review staff of potential layoffs.
The user fee program is a peculiar process. While the payments are an important source of funding for FDA, the program allows drug companies to negotiate with FDA the process for a drug's approval (particularly the speed of approval). The strings-attached approach gives drug companies far too much influence in safety reviews
Strengthening FDA's Regulatory Authority
If signed into law the bill would:
- Strengthen FDA's authority to require drug companies to perform post-market safety reviews
- Provide FDA the authority to force drug companies to change drug labeling
- Create a new database allowing FDA to collect information on adverse health effects related to drugs already on the market
- Provide FDA the authority to fine drug companies for false or misleading direct-to-consumer advertising
- Expand a program rewarding drug makers who study adverse effects of drugs on pediatric health
- Require FDA to establish labeling standards for pet food and a process by which pet food can be recalled
A number of amendments received close votes on the Senate floor. Stay tuned for a recap of that action later on.
Reg•Watch Update: Senate FDA Reform Bill: Amendment Frenzy
Posted by Matt Madia
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