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Wake Forest Faculty Member Named To Drug Safety Committee

Curt D. Furberg, M.D., Ph.D., who has been campaigning for improved drug safety for the past six years, has been named to a new advisory committee of the U.S. Food and Drug Administration (FDA) on drug safety and risk management.

The announcement came from the FDA, which said the new committee would function as a subcommittee to the standing advisory committee on Pharmaceutical Sciences. Furberg, professor of public health sciences at Wake Forest University School of Medicine, was named to a three-year term.

The FDA said the new subcommittee was comprised of nationally-recognized experts in the areas of risk perception, risk management, pharmacoepidemiology, clinical pharmacology, clinical research and medication errors who will advise FDA on safety issues.

The impetus for the creation of the subcommittee is the need for expert advice on complex drug-specific safety issues as well as methods of risk assessment, management, and communication, the FDA said. These issues play a significant role in FDA''s overall evaluation of the risk/benefit ratio of drugs.

In 1999, Furberg was one of three leading advocates for safer pharmaceuticals calling for a national office of drug safety. One major job of the new office would be to develop Areliable estimates of deaths and serious injuries from prescription drugs. They said the problem is that the FDA focuses on approving new drugs and not on monitoring drugs after they have already entered the marketplace.

"Discovering new dangers of drugs after marketing is common," said Furberg. "Overall, 51 percent of approved drugs have serious adverse effects not detected prior to approval. Merely discovering adverse effects is not by itself sufficient to protect the public.

"Each year, prescription drugs injure 1.5 million people so severely they require hospitalization and 100,000 die, making prescription drugs the fifth ranked cause of death in the United States." The appointment represents a recognition of Furberg''s work in the area of drug safety.


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