FDA to allow pharmacies to dispense abortion pills to patients

CNN
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The US Food and Drug Administration is allowing certified pharmacies to dispense the abortion medication mifepristone to people who have a prescription.

Mifepristone can be used along with another medication, misoprostol, to end a pregnancy. Previously, these pills could be ordered, prescribed and dispensed only by a certified health-care provider. During the Covid-19 pandemic, the FDA allowed the pills to be sent through the mail and said it would no longer enforce a rule requiring people to get the first of the two drugs in person at a clinic or hospital.

As of Tuesday, the in-person requirement has been permanently removed, according to Danco Laboratories, which markets the drugs under the brand name Mifeprex. Pharmacies that become certified to do so can dispense the drugs directly to someone who has a prescription from a certified prescriber. The updated information was posted Tuesday on the FDA’s website.

“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 said in a statement.

Laws vary by state, but the medications can be taken up to 11 weeks after the first day of the last menstrual period. Telehealth prescriptions are an option in some states, or a person could travel to a state where abortion is legal to get the pills.

Medication abortion is used in more than half of abortions in the US, outpacing surgical procedures for the first time in 2020, according to the Guttmacher Institute, a research group that supports abortion rights.

Pharmacy chain CVS said in a statement Tuesday that it is reviewing the updated requirements.

“We’re reviewing the FDA’s updated Risk Evaluation and Mitigation Strategy (REMS) drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy.”

Walgreens also said it is reviewing the changes.

The FDA’s move comes days after a new Justice Department legal opinion declared that federal law allows the US Postal Service to deliver the abortion drugs – a move the Biden Administration believes could help protect access to abortion in states that have enacted bans following the Supreme Court decision to overturn Roe v. Wade.

The Office of Legal Counsel opinion dated December 23, 2022, said that the 1873 Comstock Act “does not prohibit the mailing of certain drugs that can be used to perform abortions where the sender lacks the intent that the recipient of the drugs will use them unlawfully.”

“Because there are manifold ways in which recipients in every state may lawfully use such drugs, including to produce an abortion, the mere mailing of such drugs to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully,” the opinion added.

Following the reversal of Roe v. Wade last year, the USPS sought the advice of the OLC on whether federal law prohibits the mailing of mifepristone and misoprostol.

In the wake of the Supreme Court ruling, Attorney General Merrick Garland issued a statement promising to work with the FDA and other federal agencies to protect access to such drugs, which some states have sought to ban.

“States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy,” Garland said in a statement.

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