On July 11-12, Q1 Productions hosted a conference, Global Risk Management & Regulatory Policy. In some ways, the conference served as an industry-focused prelude for discussion of many of the topics that plan to be discussed at an upcoming FDA meeting on July 25 and 26 on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (“REMS”). The Conference featured presenters from industry, academia, consultants, and law, where controversial topics such as REMS assessments and shared REMS could be discussed by both innovator and generic companies in a collaborative setting.
The Conference started off with two presentations designed to provide a set of tool kits for optimizing REMS for maximum risk management effectiveness (Barbara Troupin, MD, MBA, Vice President, Scientific Communications & Risk Management, Vivus), and streamlining them for efficiency (Charles Tressler, Senior Director of Safety Surveillance & Risk Management). Christopher Milne, DVM, MPH, JD, Director of Research, Tufts Center for the Study of Drug Development, next presented an overview of a REMS report issued by the Office of Inspector General (“OIG”), Department of Health and Human Resources, entitled, “FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety” issued in February 2013. Milne explained that the OIG found that FDA’s experiment of essentially renaming risk management programs from Risk Minimization Action Plans (“RiskMAPs”) to REMS did not appear to be much of an improvement (only 22% thought it was better). The OIG found that sponsors were developing REMS too late in the product development, inconsistently submitting the required assessment reports, and the assessment reports were either incomplete or not useful to determine whether the product’s risks were being appreciably reduced by the REMS.
Milne believes that FDA is holding the upcoming public REMS meeting and has proposed a five-year analysis and integration plan to prevent further Congressional attention to REMS in the next prescription drug user fee act (“PDUFA”), expected in 2017. According to Milne, every year FDA plans to carefully review one REMS with Elements to Assure Safe Use (“ETASU”), e.g., restricted pharmacy settings or specialized training for physicians and pharmacies, registries, to improve its efficiency and risk minimization tools. Milne suggested (and various conference attendees agreed) a REMS 101-type of class is likely needed to make REMS more productive. For instance, it would be useful to collect public information about the pros and cons of all REMS tools, as well as consider ways to make REMS implementation less burdensome for physicians and patients alike. Milne noted that there are now case studies demonstrating that REMS place a large burden on patients and the health system, denying patients access to certain needed drugs with a REMS. And at the same time, sponsors are unsure what elements to include in their REMS, because FDA can at the same time complain that a REMS fails to disclose offlabel use risks, while at the same time allege that the REMS misbrands the product by suggesting the offlabel uses.