Which act authorized Risk Evaluation Mitigation Strategies (REMS) as part of its provisions?

• A. FDA Modernization Act of 1997
• B. FDA Amendments Act of 2007
• C. Family Smoking Prevention and Tobacco Control Act of 2009
• D. Patient Protection and Affordable Care Act of 2010

Answer: (B)

REMS authorization was established by the FDA Amendments Act of 2007, which gave FDA the authority to require risk evaluation and mitigation strategies for certain drugs to ensure that their benefits outweigh their risks. This act expanded FDA’s tools beyond labeling to include structured measures like restricted distribution, required patient education, provider certification, and monitoring systems when necessary for safety. An example you might recognize is the isotretinoin program, iPLEDGE, which is a REMS. The other acts set different regulatory goals—modernizing approvals and labeling, extending FDA authority over tobacco products, or broad health reform—without establishing REMS.