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).