FDA to expand availability of abortion pills

An FDA rule change will allow U.S. retail pharmacies to offer abortion pills directly to patients with a prescription, suspending a longstanding requirement that the pills be dispensed in-person by doctors or clinics. 

GenBioPro and Danco Laboratories, which make the generic abortion pill mifepristone, have said the FDA informed them about the change to its Risk Evaluation and Mitigation Strategy (REMS) for the drug, and the FDA is expected to update its website late Tuesday. 

Pharmacies that are certified in the FDA’s REMS can dispense the mifepristone directly to patients, and the in-person requirement, which was lifted during the COVID-19 pandemic, will now be permanently revoked, Danco Laboratories announced in a release.

Mifepristone, which the FDA approved back in 2000, blocks hormones necessary for pregnancy. In conjunction with misoprostol, which causes contractions, the drug is used to induce miscarriage. 

“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 GenBioPro CEO Evan Masingill in a statement shared with The Hill.

“The FDA determined that removal of the in-person dispensing requirement and the addition of the requirement for certification for pharmacies were necessary to minimize the burden on the healthcare delivery system… while still ensuring that the benefits of mifepristone for medical abortion outweigh the risks,” Masingill said. 

The FDA didn’t respond immediately to request for comment. 

The change will allow big chains to offer the drug, and also allow patients who receive a prescription via telehealth to acquire the pills at certified pharmacies, or to receive the pills through the mail where permitted under the law. 

“Today’s news is a step in the right direction for health equity. Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescription is a game changer for people trying to access basic health care,” said Planned Parenthood president & CEO Alexis McGill Johnson. 

But both Johnson and Masingill noted that the FDA change doesn’t mean abortion pills are equally accessible everywhere, amid ongoing state-level battles over the legality of abortion procedures after the fall of Roe v. Wade at the Supreme Court last summer. 

Pro-life advocates are acting in the wake of the SCOTUS decision to restrict abortions, including pushing for the FDA to revoke its approval of mifepristone.

“While we’re still fighting against bans and restrictions on medication abortion at the state level, it’s critical that people in states where abortion is legal have access to care. Today’s changes will help millions of people have more access to the care they need, when they need it,” Johnson said.

The American Civil Liberties Union’s Reproductive Freedom Project lauded the updates rules as “a major step forward for patient access,” but critiqued the move to require pharmacies to meet certification benchmarks from the Mifepristone REMS program.

“The FDA’s actions — while inching toward progress — fall short of what science and justice demand,” said ACLU staff attorney Julia Kaye. 

As of an FDA tally from 2018, more than 3.7 million women in the U.S. have used mifepristone since its first approval.