FDA and REMS: A Symbolic Start

FDA just wrapped up a two 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.

It also featured an unusually active and engaged panel of FDA officials; these agency meetings are often fairly magisterial in nature, with FDA listening but saying nothing. Not here: questions and comments aplenty.

So there is tons to digest, and we will have plenty of coverage of the meeting in The Pink Sheet, The Pink Sheet DAILY, and The RPM Report.

But we wanted to take note of how the meeting began, since we think that says volumes about where FDA is going with REMS.

The very first presenter was the American Society of Clinical Oncology’s Karen Hagerty. As we have written, ASCO has some 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 in oncology. ASCO wants to make sure that they have more input in the development of REMS in the future.

That, to us, is the key theme of the two day hearing—and it surely says something about FDA’s openness to that theme that it kicked off the two days with a panel of providers, including ASCO, the American Medical Association, specialty pharmacy execs, and Kaiser. Industry (the Pharmaceutical Research & Manufacturers of America, the Biotechnology Industry Organization, Eli Lilly) came second.

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.

It won’t be easy: after all, 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.

Take Kaiser. The non-profit health plan submitted a petition at the end of last year that really kicked off the REMS reappraisal at FDA. And Kaiser is clearly committed to seeing the process through: the non-profit had three different representatives speak during the meeting, making a total of six presentations on each of the six topics identified by FDA for the agenda.

For sponsors, the concerns raised by providers may sound like a blessing. After all, anything that stops FDA from slapping restrictive distribution programs and other post-marketing controls on new products willy nilly has to be a good thing, right?

Sure. But one other thing is clear from the two day meeting: REMS are here to stay. Providers don’t want them eliminated altogether, 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.