Gottlieb Causes Confusion With Drug-Rebate Safe-Harbor Comments

FDA Commissioner Scott Gottlieb caused confusion when he suggested Thursday (May 3) that the federal government reinterpret the treatment of drug rebates in anti-kickback regulations. Many say Gottlieb likely meant that rebates should be considered kickbacks, which would force plans and pharmacy benefit managers to use up-front discounts instead, but drug makers are calling for changes to the interpretation of safe harbor that are much less drastic. Gottlieb discussed rebate anti-kickback safe harbors in the context of the president's upcoming...