The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
The REMS is part of a multi-agency Federal effort to address the growing problem of prescription drug abuse and misuse. The REMS introduces new safety measures to reduce risks and improve safe use ofdrugs while continuing to provide access to these medications for patients.
REMS are required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks.
REMS : Key Points
• FDA can require a REMS if the agency determines that safety measures are needed beyond the professional labeling to ensure that a drug’s benefits outweigh its risks
• Drug sponsors develop REMS programs, FDA reviews and approves them
• FDA can require a REMS before or after a drug is approved
• REMS can be required for a single drug or a class of drugs
• Healthcare professionals and distributors may need to follow specific safety procedures prior to prescribing, shipping, or dispensing the drug
• Each REMS has specific safety measures unique to the safety risks associated with a particular drug or class of drugs (i.e., no two REMS are exactly alike)
Determining when a REMS is needed
• FDA may require a REMS:
– Before approval: If FDA determines REMS is necessary to ensure that the benefits of the drug outweigh the risk
– Post-approval: If FDA becomes aware of new safety information* and determines REMS is necessary to ensure that the benefits of the drug outweigh the risks
• The risk must be a serious risk that is documented in the drug’s label