US allows abortion pills to be sold at pharmacies

Retail pharmacies will be able to sell abortion pills in the United States thanks to a regulatory change made by the Food and Drug Administration (FDA), which has updated its policy on its website. The firms GenBioPro and Danco Laboratories, makers of the abortion pill mifepristone, advanced the news in separate statements cited by The New York Times.

More than half of abortions in the United States are performed via abortion pills, which are administered in the first trimester of pregnancy. The FDA’s decision facilitates access after the Supreme Court overturned the constitutional right to abortion, and gave the states the power to establish their own abortion laws.

The FDA, however, has denied that its decision was influenced by the Supreme Court ruling, or the anti-abortion laws passed by several states.

FDA’s previous Risk Evaluation and Mitigation Strategy (REMS) meant that certified prescribers had to dispense mifepristone directly to the patient in a clinic, doctor’s office or hospital. In other words, women had to pick up the medicine in person. This requirement was suspended during the Covid-19 pandemic following a lawsuit. And last year, the Biden administration announced it would no longer enforce the requirement. As a result, patients could receive prescriptions via telehealth consultations. The pills, however, could only be sold by certified physicians and clinics, and could not be dispensed by pharmacies.

Tuesday’s action formally updates the drug’s labeling to allow many more retail pharmacies to dispense the pills, so long as they complete a certification process. As stated by the FDA: “The January 2023 modification to the Mifepristone REMS Program removed the requirement that did not allow mifepristone to be dispensed from retail pharmacies.”

The sale of abortion pills will continue to require a prescription. Pharmacies must also be certified, for which they must comply with certain logistical and regulatory requirements. To obtain certification to dispense mifepristone, pharmacies must be able to receive the appropriate forms from prescribers via email and fax; ship mifepristone using a service that provides tracking information; designate an authorized representative to carry out the certification process on behalf of the pharmacy; and ensure that the authorized representative oversees the implementation of and compliance with the FDA’s REMS.

The cost of meeting these conditions may slow down the rollout of abortion pills in pharmacies, particularly large chains. What’s more, selling abortion pills is illegal under many state laws. Whether pharmacies decide to dispense the medicine or not will also depend on how the decision may be perceived by customers.

“Today’s FDA announcement expands access to medications that are essential for reproductive autonomy and is a step in the right direction that is especially needed to increase access to abortion care,” said Evan Masingill, CEO of GenBioPro, maker of generic mifepristone, said in a statement cited by local media. But she added: “Despite the FDA’s expert judgment, some states have restricted access to medical abortion care, so unfortunately today’s announcement will not provide equal access to all people.”

“At a time when people across the country are struggling to obtain abortion care services, this modification is critically important to expanding access to medication abortion services and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy,” Danco, the manufacturer of Mifeprex, said in a statement.

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