USA – FDA seeks comment on plan to increase REMS transparency

The US Food and Drug Administration (FDA) is seeking to be more transparent about its Risk Evaluation and Mitigation Strategy (REMS) program.
 
The agency is seeking public comment on its plan to publish its evaluations of how individual drug and biologics sponsors are doing on the implementation of REMS programs.
 
REMS is a long-standing drug safety program that allows the FDA to require manufacturers to implement specific safety measures that go beyond drug labeling requirements. Currently, drug and biologics manufacturers whose products require a REMS program must submit regular assessments to the FDA. The agency reviews the reports to determine if the REMS is meeting its goals and then files the reviews in its electronic archival record system. In some cases, the FDA’s reviews are shared publicly at the agency’s advisory committee meetings. The reviews can also be requested under the Freedom of Information Act…