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Focus on Regulation

Tag Archives: off-label promotion

12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter (OTC) versions of a drug product.  Under FDA’s longstanding interpretation, section 503(b) of the Food, Drug, and Cosmetic Act (FDCA) “does

Finally! FDA Announces Highly-Anticipated and Long-Awaited Public Hearing on “Off-Label” Communications

In a Federal Register notice published September 1, 2016, the U.S. Food and Drug Administration (FDA) announced a public hearing for November 9-10, 2016 on issues related to industry communications about unapproved uses of approved drugs, biological products and approved, cleared and exempt medical devices. FDA seeks input from a broad array of stakeholders, including

A New Landscape of DOJ Sanctions for Pharmaceutical and Medical Device Manufacturers

The U.S. Department of Justice (DOJ) announced another significant settlement with a pharmaceutical company earlier this week.  The settlement with GlaxoSmithKline PLC (GSK) includes:  a criminal plea, through an Information charging the company with two counts of misdemeanor misbranding as well as a single count for failure to report information about the initiation or status