Outside stakeholders seek more input on REMS

A 2-day meeting on the impact of Risk Evaluation & Mitigation Strategies (REMS) kicked off with feedback from a provider group, which expressed a desire for more input by outside stakeholders on the development of specific REMS.
 
FDA recently wrapped up a 2-day public meeting to review the implementation of its Risk Evaluation & Mitigation Strategy authorities. The hearing involved almost 70 different presentations from a diverse base of stakeholders offering input into how to make sure that REMS best allow drugs to be marketed safely without disrupting the entire health care system.

The meeting also featured an unusually active and engaged panel of FDA officials that fielded questions and comments.

The first presenter was the American Society of Clinical Oncology’s Karen Hagerty. ASCO has expressed concerns with how FDA has been developing REMS, and especially with how the agency and Amgen put together a new program for use of erythropoiesis-stimulating agents (ESAs) in oncology. Not surprisingly, ASCO wants more input in the development of REMS in the future.

The input of outside stakeholders is what prompted FDA to reconsider its REMS implementation-and we’re betting those stakeholders will end up gaining more input into the actually crafting of REMS for products going forward.

However, as FDA officials pointed out, they regulate sponsors and many of the discussions about the potential need for and design of a REMS has to remain confidential. But providers and other stakeholders want in, and they are not likely to give up until they get in.

But one other thing is clear from the 2-day meeting: REMS are here to stay. Providers don’t want them eliminated all together; they just want a seat at the table in helping to shape programs before they are launched. We’re not sure how or when they will get their way, but we bet they will eventually. And then sponsors may pine for the days when the REMS was theirs to control.