A Risk Evaluation and Mitigation Strategy (REMS) is a safety program the FDA can require for medications that pose serious risks. Under the Food, Drug, and Cosmetic Act, the FDA imposes REMS when it determines that a drug's benefits outweigh its risks only if specific safeguards are in place. These safeguards can include restrictions on who can prescribe the drug, requirements for certified pharmacies, patient monitoring protocols, and mandatory informed consent processes.
REMS programs sit between full market access and outright withdrawal — they allow risky drugs to remain available while limiting how they're distributed. The FDA reviews REMS requirements periodically and can modify them as new safety data emerges. Modifications can tighten or loosen restrictions depending on real-world evidence.
Mifepristone's REMS has become a focal point in abortion policy. The FDA's January 2023 decision to remove the in-person dispensing requirement and allow certified pharmacies to mail the drug changed access nationwide. Legal challenges to those modifications argue the FDA didn't follow proper administrative procedures, turning a drug safety program into the primary legal battleground over medication abortion.
REMS programs determine how millions of patients access medications that carry serious risks. In the abortion context, changes to mifepristone's REMS directly affect whether patients in ban states can receive medication by mail — making what looks like a technical regulatory decision one of the most consequential policy levers in reproductive healthcare.
People often think REMS means a drug is dangerous and should be avoided. It doesn't — REMS means the FDA has determined the drug is safe and effective when used under specific conditions. Many widely used medications have REMS programs, including certain opioids, blood thinners, and cancer drugs.
REMS programs determine how millions of patients access medications that carry serious risks. In the abortion context, changes to mifepristone's REMS directly affect whether patients in ban states can receive medication by mail — making what looks like a technical regulatory decision one of the most consequential policy levers in reproductive healthcare.
People often think REMS means a drug is dangerous and should be avoided. It doesn't — REMS means the FDA has determined the drug is safe and effective when used under specific conditions. Many widely used medications have REMS programs, including certain opioids, blood thinners, and cancer drugs.