The Food and Drug Administration Amendments Act of 2007: Drug safety and health-system pharmacy implications

To describe the drug safety provisions of the Food and Drug Administration Amendments Act (FDAAA) of 2007, including risk evaluation and mitigation strategies (REMS), and the implications for health-system pharmacists. The FDAAA grants FDA new authorities to require postmarketing studies or clinical trials of human drugs and to require REMS. The REMS provisions of the FDAAA represent the evolution of FDA drug safety requirements. Components of REMS include medication guides, patient package inserts, and communication plans for health care providers. For medications with known safety risks, the FDAAA requires the inclusion in the REMS process of elements to ensure safe use. These elements may include special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. Standardization of elements to ensure the safe use of drugs with known serious risks is needed so that REMS are not unduly burdensome for the health care delivery system and do not needlessly limit patient access to the drugs.