Which act authorized the FDA to require REMS?

• A. The Food and Drug Administration Amendments Act of 2007
• B. The Food, Drug and Cosmetic Act of 1938
• C. The Public Health Service Act
• D. The Prescription Drug Marketing Act of 1987

Answer: (A)

The main concept is which law gave the FDA authority to require Risk Evaluation and Mitigation Strategies (REMS). The correct answer is the FDA Amendments Act of 2007, which amended the Federal Food, Drug, and Cosmetic Act to authorize the FDA to require REMS for certain products to ensure that benefits justify the risks. This legislation expanded the FDA’s safety tools beyond labeling and postmarket surveillance, allowing specific conditions such as restricted distribution, required patient information, or healthcare provider training when needed.

The earlier Food, Drug and Cosmetic Act of 1938 established baseline safety and labeling standards but did not grant REMS authority. The Public Health Service Act and the Prescription Drug Marketing Act focus on other areas—public health protections and drug distribution controls, respectively—and do not provide REMS authority.