What program mitigates known serious safety risks for certain drugs and requires prescriber/patient enrollment, such as isotretinoin?

• A. REMS (Risk Evaluation and Mitigation Strategy)
• B. Risk Management Plan (EU)
• C. PDR System
• D. NDA

Answer: (A)

REMS, or Risk Evaluation and Mitigation Strategy, is a program required by the FDA for certain drugs with known serious safety risks. It ensures that the benefits of the drug outweigh its risks by implementing specific risk-minimization measures and requiring enrollment or certification of prescribers and patients, plus ongoing monitoring as needed. Isotretinoin is a classic example, regulated under the iPLEDGE REMS program, which mandates enrollment of prescribers, patients, and pharmacists, along with mandatory pregnancy testing and contraception to prevent fetal exposure. Other regulatory tools exist in different regions (for example, the EU uses a Risk Management Plan), but this U.S. program specifically targets safe use and access through structured enrollment and monitoring. NDA refers to the drug approval process, not a safety-mitigation program.