FDA Gets Some Recommendations

October 2006

Prompted by the dangers associated with Vioxx in 2004, the Food and Drug Administration (FDA) asked the Institute of Medicine to review their drug safety system. With the results in, the institute is recommending several changes.

Recommended changes that need approval by Congress include:

• Newly approved drugs should have a black triangle on their label for the first two years that warns consumers the safety of the drug is uncertain since it is new.
• Advertisements for drugs will not be allowed until after they’ve been on the market for two years.
• The FDA should have the right to issue fines and withdrawals when drug manufacturers do not cooperate with safety regulations.
• Once every five years, approved drugs should be re-evaluated for safety.
• All human drug trials should be publicly available.

The FDA is considering the recommendations and how to proceed.

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