Warning! FDA Is Flexing Its PMR Enforcement Muscle

On April 20, 2012, Law360 published an article titled “Warning! FDA Is Flexing Its PMR Enforcement Muscle” written by AGG Partner Alan G. Minsk and Associate Diana Rusk Cohen (subscription required; view full article at link below). A recent Food and Drug Administration (FDA) Warning Letter suggests that the agency will not hesitate, when necessary, to exercise its power to enforce postmarketing requirements (PMRs) for approved drug products. The Warning Letter states that the recipient company failed to submit a required study protocol and final study report, pursuant to the company’s PMRs and, therefore, the drug products are misbranded under the Federal Food, Drug, and Cosmetic Act. The Warning Letter is significant because it represents that the agency will take enforcement action against a company for failure to comply with PMRs. The industry will have to wait and see whether the Warning Letter represents a new wave of enforcement, but it signals that FDA will act and companies should stay focused on complying with PMRs. The article was first published in the March 21, 2012, edition of the AGG Healthcare Authority weekly newsletter and originally titled “Recent FDA Warning Letter Enforces Postmarketing Requirements: A Sign of Things to Come?”