Article Examines Trends in FDA’s Use of Class-Wide REMS

December 27, 2009

By William T. Koustas

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.  (See our REMS Tracker.)  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 authored by Hyman, Phelps & McNamara’s William T. Koustas, titled “Trends in FDA’s Use of Class-wide REMS,” explores the current state of class-wide REMS through interesting and relevant examples.  Understanding FDA’s current implementation of class-wide REMS may be the best means of preparing for the future use of REMS.  

Categories: Drug Development