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The Future of Drug Safety

September 25, 2006

The Institute of Medicine (IOM) of the National Academy of Sciences has released a report on The Future of Drug Safety: Promoting and Protecting with recommendations to strengthen the role of the Food & Drug Administration (FDA) in ensuring the safety of prescription drugs sold in the United States.
The recommendations include:
  • A large increase in FDA funding and staff
  • Clarified authority and additional enforcement tools for the agency
  • Mandatory registration of clinical trial results to allow public access to drug safety information
  • Clarification of FDA's role in gathering and communicating additional information about the risks and benefits of drugs once they are on the market.
  • Labeling requirements and advertising limits for new medications 

"We found an imbalance in the regulatory attention and resources available before and after approval [of  prescription drugs]," said Sheila Burke, chair of the committee that wrote the report. "Staff and resources devoted to pre-approval functions are substantially greater. Regulatory authority that is well-defined and robust before approval diminishes after a drug is introduced to the market.  Few high-quality studies are conducted after approval, and the data are generally quite limited. Many of the report's recommendations are intended to bring the strengths of the pre-approval process to the post-approval process, to ensure ongoing attention to medications' risks and benefits for as long as the products are in use."

Read more about the report from the Institute of Medicine. (opens in a new browser window)