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FDA finalizes rule change expanding access to abortion pills across U.S. pharmacies

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  • Staff Report 

The Food and Drug Administration has finalized a rule change that will allow many more pharmacies, including mail-order companies and large chains, to dispense abortion pills. The change, which was partially implemented last year by the Biden administration, updates the drug’s labeling to permit retail pharmacies to dispense the pills after completing a certification process. Women can get a prescription via telehealth consultation with a healthcare professional and then receive the pills through the mail where permitted by law.

While the change could expand access to abortion pills at physical stores and online pharmacies, it has been dampened by numerous state laws that limit abortion and access to the pills. Legal experts predict that there will be years of court battles over access to the pills as abortion rights advocates bring test cases to challenge state restrictions. More than half of abortions in the US are now done with pills rather than surgery, according to the Guttmacher Institute, a research group that supports abortion rights.

For over 20 years, the FDA labeling had limited dispensing to a subset of specialty offices and clinics due to safety concerns. During the COVID-19 pandemic, the FDA temporarily suspended the in-person requirement. The agency later said that a new scientific review by agency staff supported easing access, concurring with numerous medical societies that had long said the restriction wasn’t necessary.

Two drugmakers that make brand-name and generic versions of abortion pills requested the latest FDA label update. Agency rules require a company to file an application before modifying dispensing restrictions on drugs. Danco Laboratories, which sells branded Mifeprex, said in a statement that the change “is critically important to expanding access to medication abortion services and will provide healthcare providers” with another option for prescribing the drug. The American College of Obstetricians and Gynecologists called the update an “important step” forward.