Congress passes FDA Amendments Act, formalizing REMS authority over high-risk drugs

President George W. Bush signs the FDA Amendments Act of 2007, formally codifying the FDA''s authority to impose Risk Evaluation and Mitigation Strategies on drugs with serious safety concerns. Before this law, REMS-style restrictions existed but lacked explicit statutory authorization. The Amendments Act gives the FDA''s mifepristone restrictions firm legal grounding that opponents must attack directly rather than challenging as unauthorized agency action. It also requires the FDA to periodically review whether REMS conditions remain necessary — a provision that advocates later use to argue the in-person dispensing requirement for mifepristone should be lifted as safety data accumulates.