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Newly-Approved Medicines Are Not Necessarily Safe

Study Criticizes FDA's Post-Approval Monitoring of Medicines

WASHINGTON, DC -- September 29, 2006 -- Medicines that are approved for sale by the Food and Drug Administration (FDA) are not necessarily safe and effective, according to a new study by a committee of the Institute of Medicine (IOM). "It is a widely held misperception that FDA approval of a new drug denotes a guarantee of safety and certainty about its risk-benefit profile," the committee noted. It found that "few high-quality studies are conducted after approval, and the data [is] generally quite limited."

The IOM called for better post-approval monitoring of medicines and made these recommendations:

  • A newly approved drug should carry an alert on its package label for a two-year period to warn consumers that the product is new and that its risks and benefits are uncertain.
  • FDA teams should regularly analyze all postmarket study results. Five years after a medicine is introduced, the FDA should conduct a formal review of all accumulated information about the drug's risk and benefits.
  • There should be no direct-to-consumer advertising during the first two years after a drug is approved. If this is not feasible, the ads should at least note that the drug's safety profile is "less developed than for older drugs."
  • A drug company should register all clinical trials about a medicine, whether conducted prior to or after it has been approved.

The FDA does not demonstrate that it is accountable to the public, nor keep consumers sufficiently informed about health and safety concerns, the report concluded. Currently, the FDA allows individuals with financial ties to the drug industry to serve on its advisory panels. The report did not go as far as recommending that no committee members have industry ties. Instead, the IOM suggested that at least 60% be independent of the drug manufacturers.

The IOM committee also commented on the FDA's dysfunctional culture and organizational structure, making suggestions for improvement. One way to bolster the role of drug safety staff, it noted, would be to give the FDA's Office of Surveillance and Epidemiology (formerly the Office of Drug Safety) joint authority with the Office of New Drugs for reviewing drug safety issues after a drug has been approved. A six-year term for the FDA commissioner would provide greater stability for the agency, the report said.

Finally, the report mentioned that the FDA is not allowed to issue fines and injunctions to drug companies that do not comply with label changes and other requirements. The agency should be given this legal authority, the IOM group concluded. It also acknowledged that the FDA is severely underfunded and needs more staff to ensure post-approval drug safety.

The IOM report comes two years after the arthritis drug, Vioxx®, was removed from the market because it increased the risk of heart attacks and strokes. The FDA had been taken to task for allowing the medication to remain on the market for several years and for not promptly advising the public of its dangers.

Prescription Drug Injuries

Brayton Purcell is currently reviewing cases of individuals who have been injured by harmful prescription drugs. Please feel free to contact us for more information. Our firm has been handling medically-related legal cases for over 20 years, including those involving unsafe or ineffective medications.

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