KHN Morning Briefing

Summaries of health policy coverage from major news organizations

PhRMA Asks FDA To Be More Straightforward On Safeguards It Wants To Fight Drug Risks

The pharmaceutical industry trade group PhRMA said Monday that the Food and Drug Administration should do a better job of explaining additional safeguards it mandates against certain drugs when it issues warnings, Reuters reports. "That recommendation is one of dozens expected this week at a public meeting on the FDA's risk evaluation and mitigation strategies, or REMS, a set of tools to protect consumers from drugs with potentially serious side effects." The FDA requires drugmakers to provide consumers information on potential drug risks by publishing medication guides and/or training of physicians who prescribe certain drugs.

"The tools are among new FDA powers included in a 2007 law. Since the law took effect in 2008, the FDA has mandated risk-minimizing strategies for more than 120 drugs. … PhRMA said that the FDA should implement the medication guides outside of the REMS framework, something the agency has done in the past" (Lentz, 7/26).

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