Dear Dr. Woodcock,
We, the undersigned, respectfully request the U.S. Food and Drug Administration (FDA) reconsider its limitation of the recently released Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency (Docket FDA-2020-D-1106).
The policy waives certain Risk Evaluation and Mitigation Strategies (REMS) requirements – namely laboratory tests and imaging – but not others. The requirements that certain drugs must be dispensed in-person by certain medical professionals provides similar burdens and risks to patients and providers as the waived requirements. Therefore, we request that in-person dispensation requirements, specifically for mifepristone, be included in this policy as temporarily waived.