Gottlieb: FDA Drafting Guidance On OTC E-Cigarettes, Gene Therapy, Genetically Modified Animals

FDA Commissioner Scott Gottlieb, in a wide-ranging speech at the annual Food and Drug Law Institute conference Thursday (May 3), announced a slate of new agency projects, including: making e-cigarettes over-the-counter drug products; reorganizing the FDA drug center; rethinking the regulatory approach toward gene therapy; and developing a framework for regulating genetically modified animals. Gottlieb also provided a sneak peak of the president’s upcoming drug pricing plan , and suggested that HHS look at repealing the anti-kickback safe harbor for...