Rosen Quoted on Consent Decree

Washington, D.C. Partner David Rosen was quoted in an Inside Health Reform article on July 17, 2013 titled, “FDA Legal Action Holds N.J. Compounder to Manufacturing Standards.” The article discusses a recent consent decree of permanent injunction against a drug compounder that FDA previously flagged mandates the pharmacy follow drug manufacturer standards. Mr. Rosen was quoted saying, “They’re holding them to drug manufacturer-style GMPs.” He also noted that drug companies involved in consent decrees sometimes enter a plan to rehab some of their products, whether it be active pharmaceutical ingredients or ingredients in process, but this must be approved by FDA and there is often a bond to ensure it is carried out.