Wednesday, May 31, 2006

Institute of Medicine workshop: advising the FDA, improving drug safety

There's currently a two-day workshop convening at the Institute of Medicine (IOM) to gather experts' advice for the Food and Drug Administration (FDA). Highlights of an expert panel on the first day include:
  • "Toning down" drug advertisements to temper patient expectations

  • Providing simpler display strategies (e.g. graphics, charts, tables) for comparing risks and benefits of different therapeutic options to aid patients and clinicians with the decision-making process

  • Continuing efforts to simplify drug labels

(More on this workshop via Reuters, "Less ads, more data urged for drug safety", May 30, 2006)

There is also a pending Institute of Medicine report, expected to be released in July 2006, examining the FDA's practices for assessment of drug safety, focusing particularly on improving the national system for post-marketing surveillance of potential additional adverse effects. The IOM site contains meeting agendas, transcripts, and audio files of open meetings related to this project to date.

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