REMS Evaluations Not Perfect, FDA Questions Assessment Methods

The FDA is questioning surveys and other assessment methods drugmakers are using to evaluate whether risk evaluation and mitigation strategies (REMS) work. An initial review shows several shortcomings. Assessments are a key part of REMS, which were dictated by the 2007 FDA Amendments Act. One of REMS’ goals is to educate patients and physicians about a drug’s risk versus benefit and safe use. In an issue paper out this week, the FDA analyzed 144 REMS assessments with surveys for 105 individual drugs. Most would not meet social science research standards, the agency said.
Washington Drug Letter