FDA Rebuffs PhRMA, Weighs Off-Label Use In Deciding If REMS Needed

FDA will consider the extent to which a drug’s intended population is expected to use the product for off-label uses when deciding whether to require a risk mitigation program for certain drugs, a policy the brand industry had alleged may exceed the agency’s statutory authority. The decision is tucked into a final guidance issued Thursday (April 4) that lists six factors FDA will consider when weighing whether a Risk Evaluation and Mitigation Strategy (REMS) is needed to ensure a drug’s...