This is part two of a summary of an FDA public meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (“REMS”) held in FDA’s White Oak campus on July 25-26, 2013. On both days, public speakers offered their views on how to standardize REMS and better evaluate whether individual REMS elements are working to reduce the risks intended. FDA requested speakers to post their slide decks on the docket for this meeting, Docket No. FDA-2013-N-0502, as well as additional comments prior to September 16, 2013 to be considered for the REMS Integration Initiative Report.
While a variety of comments were made by speakers, many of the comments circled back to similar themes. Below is an attempt to capture a flavor of many of the comments, but more details will be made available in the coming month or so in FDA’s Docket. None of the speakers knew who was going to speak or on what topics/viewpoints, and many of the comments reflected company speeches that had been approved in advance of the meeting. Therefore, there was a certain amount of repetition of topics, which I have tried to reduce where possible, which resulted in a somewhat skewed summary leaning towards earlier speakers. For example, multiple speakers, including pharmacy chains such as CVS Caremark, recommended a single REMS portal to process claims in a more efficient workflow rather than multiple websites and portals that put an increased burden on the healthcare system.
- On the first day, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) (Sarah A. Spurgeon) kicked off the public session with a request for using the same REMS elements for the same risks, a “one-stop-shop” for all REMS systems on the Internet with a link to all REMS websites with less paperwork, an FDA logo for REMS-official programs, and templates for risk communication. Another PhRMA speaker on the second day (Sarah A. Spurgeon) supported research to determine the most effective REMS elements and asked FDA to consider selectively removing elements from REMS after proper assessment tools are validated. Also on the second day, FDA asked PhRMA to go its members and try to gather data concerning assessment tools and data whether those REMS tools are working, as well as whether post approval REMS are being streamlined or additional elements are being added in the interest of further risk management that may be increasing the burden on the healthcare system.