FDA Commissioner promises action on REMS misuse

US Food and Drug Administration Commissioner Scott Gottlieb has announced new draft guidance for the pharmaceutical industry affecting Risk Evaluation and Mitigation Strategies (REMS) submissions.

Dr Gottlieb said the US FDA was exploring a “two-pronged approach” to reforming the scheme, which was set up in 2007, by law, to manage any known or potential risks associated with a drug or biological product.

A REMS submission from a pharmaceutical company is required if the FDA thinks it is necessary to ensure that the benefits of the product outweigh the risks.