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Posted on 01.23.02
CERTs PIs Tapped for New FDA Advisory Subcommittee
By Pat French
The U.S. Food and Drug Administration has created a new subcommittee to the Advisory Committee for Pharmaceutical Science: the Drug Safety and Risk Management Subcommittee.
According to a December 18 Talk Paper from the FDA, the subcommittee will include national leaders in risk perception, risk management, pharmacoepidemiology, clinical pharmacology, clinical research, and drug errors. These leaders include two members of the Centers for Education & Research on Therapeutics (CERTs) Steering Committee, Dr. Bill Campbell of UNC and Dr. Brian Strom of the University of Pennsylvania.
The subcommittee will advise FDA on general and product-specific safety issues during the evaluation of new drugs and new uses for existing drugs. This fits in nicely with the mission of the CERTs, for which Duke University is the Coordinating Center.
"The goal of the CERTs is to optimize the risk/benefit ratio of medical products," says Dr. Rob Califf, Director of the CERTs Coordinating Center. "Having CERTs Steering Committee members on this subcommittee is a logical extension of this mission. As the FDA moves more vigorously to implement programs of risk management, I expect that this committee will play an important role in giving both general and specific advice to the FDA."
The subcommittee was created because the FDA recognized the need for expert advice on complex, drug-specific safety issues and on methods of risk assessment, management, and communication. Recent recalls of drugs and devices have raised concern about whether our current system can be improved.
The subcommittee is expected to hold its first public meeting in spring 2002.
For the Talk Paper, visit the FDA site at http://www.fda.gov/bbs/topics/ANSWERS/2001/ans01127.html. For a roster of the subcommittee members, visit the FDA site at http://www.fda.gov/ohrms/dockets/ac/02/roster/3848R1_04_DSaRM.htm.