Public Citizen Challenges FDA to Justify REMS Decisions

FDA decisions to require a risk mitigation plan or to discontinue one already in use often rely on a small amount of data that fails to justify the move, Public Citizen’s senior health advisor says. Speaking during the second day of a two-day public meeting hosted by the agency to discuss ways to standardize and evaluate the effectiveness of Risk Evaluation and Mitigation Strategies (REMS), Public Citizen’s Sidney Wolfe challenged the FDA to define the criteria used to deem a high-risk drug worthy of a REMS.
Drug Industry Daily