Over the past several decades, the Food and Drug Administration (FDA) has employed a number of "risk management" programs designed to detect, evaluate, prevent, and mitigate drug adverse events for drugs with the potential for serious adverse drug reactions. Some of the risk management plans used by the FDA over the years have included the use of patient package inserts, medication guides, restricted access programs, and classification of drugs as controlled substances. These programs were acknowledged by the FDA as Risk Minimization Action Plans (RiskMAPS) in 2005. With these programs, the FDA only had the authority to mandate postmarketing commitments from drug manufacturers before the drug was approved; however, these requirements could not be enforced after the drug was approved.

The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to subject drugs to new risk identification and communication strategies in the postmarketing period. These new strategies, called Risk Evaluation and Mitigation Strategies (REMS), can be required for any drug or drug class that is associated with serious risks. The FDA can require a REMS if it believes that this program is necessary to ensure that the benefits outweigh the potential risks of the drug. The FDA can require a REMS either as part of the drug approval process or during the postmarketing period if new information becomes available regarding potentially harmful effects that are associated with the use of the drug.

Components of the REMS may include a medication guide, a patient package insert, and/or a communication plan. A REMS for New Drug Applications or Biologics License Applications requires a timetable for submission of assessment of the REMS. A variety of elements to ensure safe use of drugs can be required as part of the REMS if it is believed that a medication guide, patient package insert, or communication plan are not adequate to mitigate the serious risks associated with a particular drug. These elements may include the following:

• Health care providers who prescribe the drug are specifically trained and/or certified.
• Pharmacies, practitioners, or health care settings that dispense the drug are specifically trained and/or certified.
• The drug is dispensed to patients only in certain health care settings, such as hospitals.
• The drug is dispensed only to patients with evidence or other documentation of safe-use conditions, such as laboratory test results.
• Patients using the drug are subject to certain monitoring.
• Patients using the drug are enrolled in a registry.

The FDA maintains an updated list of these REMS programs at https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm. A REMS tag has been added at the top of and within the monographs of drugs associated with these programs.