Was the REMS meant to regulate prescribers and pharmacists?

Posted by cdavenport on Sunday Oct 11, 2009 Under Risk Management

As of 2007, the FDA has the  authority to require a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs and biological products, to ensure that the benefits of such products outweighed the risks.  Although the FDA mandated risk-management plan applies only to prescription drugs and biologicals, the effect of a REMS extends down the supply chain to affect which physicians may prescribe and how pharmacies dispense medication, even though the FDA has no regulatory authority beyond manufacturers.  Ned Milenkovich (Modern Medicine, 8 Oct 2009) poses the question, therefore, whether Congress and the FDA are exceeding their authority by indirectly regulating professions that traditionally have been governed by the various states?  This article gives a good overview of the status and use of REMS by the FDA and Industry and considers the indirect effects.

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2 Responses to “Was the REMS meant to regulate prescribers and pharmacists?”

  1. Michael Swit Says:

    FDA and Congress have been indirectly regulating medicine for years. Every time FDA approves a drug, the approved labeling impacts the practice of medicine by providing hopefully clear guidance on when doctors should or should not use a drug. If the doctor wants to deviate from the approved labeling, he/she can and they do not violate FDA law. However, at that juncture, state law relating to practice of medicine and informed consent remains a check on the doctor’s practice of medicine regardless of FDA’s role. Thus, I don’t understand the relevance of Dr. Milenkovich’s question in his article.

  2. cdavenport Says:

    Thanks for joining the discussion Michael! I concur with your logic. I think the major point of disagreement comes in that the author of the Modern Medicine article felt that the states already had regulation well in hand and did not need the REMS to “fix what was not broken.” However given how relatively easy it is for people to get drugs from less than scrupulous providers under the current system, I personally have no problem with the REMS adding additional oversight as warranted.


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