In remarks made to the FTC on November 8, 2017, FDA Commissioner Scott Gottlieb, M.D. stated, in part: “So my message is this: end the shenanigans. Branded companies’ use of REMS – which FDA adopts as a way to ensure the safe use of certain drugs – is also sometimes being used as a way to frustrate the ability of generic firms to purchase the doses of a branded drug that they need to run their studies. This needs to stop. I believe drug makers also sometimes use restrictive agreements with pharmaceutical supply chain intermediaries – like specialty pharmacies – to frustrate or block the sale of a branded drug to a generic firm. I consider these tactics unfair and exploitative practices, and they’re in direct conflict with our broader public health goals. These practices frustrate the generic drug regulatory system that Congress created, and that Americans depend on FDA to execute. So in coming weeks I plan to take other steps to address this anti-competitive behavior. Among other things, I’m going to contact pharmaceutical supply chain intermediaries to inform them of the FDA’s interest in making sure that generic firms can gain access to the doses they need to run bioequivalence studies. When intermediaries sign on to these restrictive games, I want them to know that they’re challenging a broader public health goal.”
Here’s a link to the speech, corresponding FDA Statement entitled “Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access,” and a link to contact us for help with your complex drug submission.