Effective March 25, 2008, the Food and Drug Administration Amendments Act of 2007 (FDAAA) reserved the right for the U.S. Food and Drug Administration (FDA) to order Risk Evaluation & Mitigation Strategies (REMS) for drugs or biologics with significant
toxicity levels and/or demonstrable risk factors. These strategies are meant to ensure that the benefits of particular drugs continue to outweigh the risks that they pose for patients. REMS are currently being mandated to assess adverse risks associated
with specific oncologic drugs, biologics, and supportive care therapies.
A drug's REMS program may not require the provision of all three components, as the specific components a REMS program employs will vary based on the severity of the risks, the population likely to be exposed, and other factors. In fact, the most common
REMS only require the provision of a medication guide.
While REMS components are not uniform, some do and will contain new provisions and requirements for physicians and other certified health care providers. For REMS requiring ETASU, clinicians may be required to:
obtain and dispense drugs through specific distribution channels
possess specific training, education, experience, or certification(s) in order to prescribe these drugs
enroll patients in registry programs
issue mandatory, time-sensitive reports of patient responses to treatment
Your ability to prescribe and dispense certain medications, even some that have been on the market for years, could be contingent upon compliance with these REMS provisions.
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