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The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.
FDA has weighed into the escalating abortion policy battle by taking steps to expand patient access to the abortifacient mifepristone from pharmacies and physicians. The agency revised a regulation to enable local pharmacies to dispense the pill directly to individuals with a prescription, instead of requiring patients to visit a certified physician to obtain the drug. A related change also makes permanent its policy of permitting providers to prescribe the medicine via telemedicine visits.
In addition, the Department of Justice (DOJ) clarified that it is not unlawful for the US Postal Service (USPS) to deliver abortion drugs, even in those states with strict limits on pregnancy termination. In a 20-page legal opinion issued Dec. 23, 2022, DOJ affirmed that the mere act of mailing approved drugs does not violate the law. and that there may be circumstances even in states with strict curbs on abortion where the use of such medication is permitted. USPS had asked DOJ for guidance on the issue as efforts expanded to deliver abortion pills through the mail in states with strict abortion curbs following the Supreme Court decision in June 2022 striking down established federal rights to abortion.
FDA revised its dispensing policy for mifepristone by altering certain provisions of its Risk Evaluation and Mitigation Strategy (REMS) for the drug. The change was requested by manufacturers Danco Laboratories and GenBioPro, which produces a generic version. Under the revised REMS, chain and independent pharmacies that become certified in the program may dispense the drug directly to patients presenting a prescription from a certified prescriber, as explained in FDA’s review of the proposed REMS modification.
Danco, which has produced mifepristone for 20 years, praised the FDA policy change, noting the critical importance of its product in providing a “safe and effective option for ending early pregnancy” at a time when people across the country “are struggling to obtain abortion care services.” The manufacturer explains that FDA modified the prescriber and patient agreements in the Mifepristone REMS and added a new pharmacy agreement, noting that it will phase in these changes over several months to avoid disruptions in dispensing mifepristone by current providers in clinics and hospitals.
In addition, FDA aims to make it easier for patients to obtain a prescription for mifepristone by making permanent its temporary health access policy change in 2021. The agency had cancelled the “in-person” requirement that patients physically visit healthcare providers to obtain a prescription for the abortion drug, a restriction originally backed by abortion foes seeking to limit access to the drug.
Despite these FDA policy changes, women in states with strict abortion curbs still will have to travel to other states to obtain mifepristone from a drug store. At the same time, major pharmacy chains may not rush to become certified to dispense abortion pills. And the clarification that it’s legal to mail abortion pills is not expected to facilitate mail delivery in states with highly restrictive policies.
The REMS revision and FDA’s support for telehealth prescribing puts the agency squarely in the center of the escalating debate over access to medicated abortion, which now accounts for half the abortions in the United States. Already, lawsuits have challenged FDA’s original approval of mifepristone for ignoring safety issues, and the new policies are expected to generate a wave of legal actions from anti-abortion groups and state agencies, as well as citizens’ petitions seeking more restrictive FDA labeling on the these products.
Jill Wechsler is Washington reporter for BioPharm International.