Trends in FDA’s Use of Class-Wide REMS

December 23, 2009

As FDA becomes more comfortable with the authority provided to it by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), the frequency of Risk Evaluation and Mitigation Strategies (“REMS”) being applied to an entire class of drugs is increasing. The most notable example of this is the class-wide REMS for extended-release opioid drugs, where FDA may impose onerous new requirements on the manufacturers, prescribers, dispensers and consumers of such products. In light of these developments, a recent article in the December issue of the Regulatory Affairs Professionals Society’s Regulatory Focus publication explores the current state of class-wide REMS through interesting and relevant examples.