Both the Institute of Medicine and the five experts would ban consumer
advertising of newly approved classes of drugs until they have been on the
market long enough for any problems to emerge; give the agency new powers to
fine drugmakers that fail to complete required safety studies; and take steps to
limit conflicts of interest and broaden the range of expertise on panels
appointed by the agency to review scientific data on proposed drugs.
But the experts went further by calling for a Center for Drug Safety outside of the CDER and increased FDA funding for safety monitoring, perhaps through a fee of a few cents on every prescription. They also recommend giving "conditional approval"
to some drugs to require drugmakers to demonstrate a drug's safety or else risk
seeing it pulled from the market.
Focus on drug safety stems from such recent problems as Merck's withdrawal of Vioxx from the market. Drug safety legislation is expected to be a hot topic in the next Congress, which convenes in January 2007.