The US Food and Drug Administration (FDA) Tuesday announced that it will allow Mifepristone, a drug used during a medication abortion, to be dispensed by certified retail pharmacies. Mifepristone is used in conjunction with Misoprostol to terminate pregnancies of up to ten weeks’ gestation without the need for surgical intervention. Previously, the drug could only be dispensed in certain health care settings such as clinics, medical offices and hospitals.
Though the new rules alleviate some of the requirements for dispensing the drug, Mifepristone cannot be accessed over-the-counter and must still be prescribed by a healthcare provider. Although patients seeking access to the drug are no longer required to see the prescriber in person, health care providers will still need to be certified under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) Program. REMS certified prescribers will continue to be required to accurately date pregnancies, provide or arrange surgical intervention and ensure patients have access to medical assistance for emergency care.
In a statement, Mifepristone manufacturer Danco Laboratories stated:
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.
It is currently unclear how the new FDA rules will interact with anti-abortion legislation introduced in a number of states following the overturning of Roe v. Wade. The FDA has indicated that it will communicate with the Department of Justice to resolve preemption conflicts between state and federal law.
In an opinion issued last month, the Department of Justice confirmed that the US Postal Service is not prohibited from mailing drugs for medication abortions.