FDA's risk evaluation and mitigation strategies (REMS): effective and efficient safety tools or process poltergeist?

Implementation of REMS began in March 2008 and by mid-2011 close to 200 New Molecular Entities (NMEs) and New Drug Applications (NDAs) (i.e., NMEs plus new doses and formulations of drugs) approved by FDA were required to have a REMS. As the REMS program expands, there has been an increasing chorus of stakeholders who have expressed a range of concerns and criticisms about the program's impact on the health care system. Yet, these impacts still remain underexplored by academic study. The authors conducted a series of qualitative interviews with individuals representing the experiences and opinions of five stakeholder groups involved in various aspects of REMS programs. The groups were comprised of representatives of biopharmaceutical companies, payers, health care providers (HCPs), pharmacists, and patient advocacy organizations. Questions were organized around the following themes: REMS implementation and administration; REMS components (i.e., medication guides, communication plans, and elements to assure safe use); effects on patient access and delivery of care; program outcomes; and, issues specific to each stakeholder group. What was most surprising was not that respondent groups with such divergent perspectives and diverse roles within the REMS program disagreed on certain points, but rather that they agreed on so many points. There was general agreement that the program is burdensome and not an improvement over previous risk management programs. Respondents also concurred almost unanimously that the patient information is weighted much too heavily on the risk end of the risk/benefit scale. Similarly, there was general concern from all the responder groups about uncompensated time and resources expended by HCPs and pharmacists. While some positive aspects were noted, these tended to be viewed as opportunities for improvement rather than actual benefits of the REMS program as currently implemented. As PDUFA V draws ever nearer, it's clear that FDA is attempting to address the program's shortcomings but it is clear that more needs to be done.