FDA moves from whether to how to standardize REMS

At agency’s 2-day meeting, APhA advocates for integration of REMS into existing workflows

APhA has long supported efforts to standardize Risk Evaluation and Mitigation Strategies (REMS). Now FDA says it “has committed to standardizing REMS” on its website. As part of the reauthorization of the Prescription Drug User Fee Act, the agency held a July 25–26 public meeting to learn from stakeholders on how to standardize and assess REMS for drug and biological products.

At the FDA meeting, the Association advocated for ideas such as integration of REMS into existing workflows, an FDA website clearinghouse for all REMS information, a risk-based tier system to organize REMS programs, simplification of REMS patient education materials, and the inclusion of REMS patient education into medication therapy management (MTM) programs when possible and where fair reimbursement is available.

APhA Senior Vice President of Government Affairs Stacie Maass, BSPharm, JD, spoke on the panel for REMS tools in dispensing settings. The Association will submit written comments to FDA by September 16.

Progress clearly has been made on the REMS initiative, with FDA including a lot of what stakeholders have said previously in coming up with its questions listed in the May 22 notice of the meeting and request for comments, according to APhA Director of Regulatory Affairs Jillanne Schulte, JD.

“Now we’re really getting into brass tacks,” Schulte told pharmacist.com. “I think that before, there’s always been this higher level discussion of whether they should standardize. And now that they’ve decided to move forward with standardization, it seems like everyone agrees that’s a good idea. The level and degree of standardization, of course, are going to be up for discussion.”

Added Schulte, “There’s definitely some pushback from manufacturers who want to have a large degree of flexibility in what they’re allowed to do with their REMS programs.”

There’s also the issue of data—and that’s one reason FDA is very interested in MTM, which would provide them with “some really great data that they wouldn’t otherwise get,” Schulte said. Such data could indicate exactly why patients aren’t taking their medication, exactly how REMS are affecting patient use of medication, and what from the REMS protocols works and what doesn’t.

Right now, there’s not really baseline data on the whole universe of REMS programs because it’s just too much and it changes too fast, according to Schulte.

A webcast of the REMS meeting is available on the FDA website.

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