MoFo Life Sciences
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and through telemedicine in order to reduce the burden on patient access. This policy change will be effected by the drug’s manufacturers making modifications to their Risk Evaluation and Mitigation Strategy (REMS), a program to restrict distribution of drugs that, in FDA’s judgment, is necessary for the safe and effective administration of such drugs. The FDA announcement stated that it had ordered the drug’s manufacturers to modify their shared-system REMS to remove the requirement that mifepristone be dispensed only in certain certified in-person healthcare settings and allow for certified pharmacies to dispense the drug. While the FDA’s announcement was met with much breathless commentary by proponents and opponents of the new policy, implementation is most likely at least a year away, and conflicts with many state laws may preserve the status quo until resolved by a court, effectively preventing mail order delivery of the drug or telemedicine prescribing of the drug in states that currently prohibit such practices.
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