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PhRMA Asks FDA to Clarify Warnings

  • July 29, 2010
  • RPh on the Go

The Food and Drug Administration is currently hosting a two day hearing in an attempt to gather responses on the FDA guidance that is currently given on some prescription medications. The meetings deal specifically with the Risk Evaluation and Mitigation Strategies (REMS) that are assigned to specific drugs. The REMS require drug makers to provide addition information and for doctors and pharmacists to take specific precautions when prescribing drugs that the FDA considers high risk.

The Pharmaceutical Research and Manufacturers of America (PhRMA) plans to use the two day hearings to request that the FDA streamline the REMS by providing clearer indications of why the additional precautions are placed on some drugs. The spokesman for PhRMA noted that the warnings and precautions are often confusing and sometimes contradictory. The REMS also require that patients be administered a survey to determine if the additional information provided is helping to communicate the drug risks. PhRMA notes that the surveys add another layer of administration to an already complicated process.
The FDA did no
t comment on the requests prior to the start of the hearings. The purpose of the meeting is to gather the feedback and evaluate if future changes might be needed.


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