FDA Allows Pharmacies to Sell Abortion Pills—But Requires Unnecessary and Burdensome Certification Process

Abortion rights activists demonstrate in front of the U.S. Supreme Court on Dec. 1, 2021, as the justices hear arguments in Dobbs v. Jackson Women’s Health, a case which ultimately resulted in the overturn of Roe v. Wade in June 2022. (Chip Somodevilla / Getty Images)

On Jan. 3, the U.S. Food and Drug Administration (FDA) announced a new certification process for brick-and-mortar pharmacies to become eligible to sell the abortion pill mifepristone for the first time. Reproductive rights advocates celebrated the change, hoping it will expand access to abortion pills.

“Today’s announcement means that people who live in states that have not banned medication abortion care may soon be able to walk into their neighborhood pharmacy and walk out with their medications in hand,” said Kirsten Moore, director of Expanding Medication Abortion Access (EMAA) Project, a leading advocate for increased access to medication abortion. “By allowing brick-and-mortar pharmacies to dispense medication abortion care, the FDA is treating medication abortion like the safe, effective, time-sensitive care that it is.”

In December 2021, the FDA announced the policy change to allow certified pharmacies to sell abortion pills, and have since then been negotiating with the abortion pill manufacturers Danco and GenBioPro to develop a process to certify pharmacies.

“We applaud the FDA for lifting unnecessary requirements on medication abortion,” said Morgan Hopkins, president of All* Above All. “This brings us one step closer toward a future where people can get the care they need in ways that are comfortable and make sense for them, including at a local pharmacy like any other prescription.”

This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care, rather than waiting for a mail order if that is right for them.

Dr. Iffath Abbasi Hoskins

Before the change, certified providers had to stock and distribute the pills themselves, or rely on mail order pharmacies that distribute the medication, including American Mail Order Pharmacy, Manifest Pharmacy and Honeybee Health. With the new certification process, providers can just write a prescription and have it filled by local brick-and-mortar retail pharmacies, making it more quickly and conveniently available to patients.

“Allowing for brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone for reproductive health indications will further improve access for patients,” said Dr. Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists (ACOG). “ACOG has long advocated that mifepristone be made available in retail pharmacies, just like other prescription drugs, to allow more patients access to abortion care without clinically unnecessary hurdles. This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care, rather than waiting for a mail order if that is right for them.”

Research has shown that pharmacist dispensing of medication abortion is safe, effective and acceptable to patients.

“While long overdue, the FDA’s announcement is a step in the right direction,” said Dr. Ushma Upadhyay, professor at Advancing New Standards in Reproductive Health and an expert on the safety and effectiveness of medication abortion. “The science is clear that medication abortion is safe and effective, whether provided in a clinic or at home via telehealth.”

But the FDA is still blocking mifepristone from being available in pharmacies like any other drug by requiring pharmacies to register with the drug manufacturer in order to distribute the drug, despite the fact that mifepristone is safer than many over-the-counter medications, including Tylenol.

“Even as the FDA drops one onerous restriction, it adds another—a certification requirement for pharmacies, which is not supported by medical evidence and could present a large enough hurdle that will dissuade some from dispensing,” said Upadhyay.“With abortion restricted in large parts of the country, we need our public health policies to follow the science so people can have access to this essential medication.”

Advocates expressed concern about whether busy pharmacies will be willing to take on the extra work to become certified to distribute abortion pills.

“This is just a bunch of paperwork that doesn’t add any value,” says Moore, who said it may be a while before mifepristone is available in pharmacies.

Even as the FDA drops one onerous restriction, it adds another—a certification requirement for pharmacies, which is not supported by medical evidence.

Dr. Ushma Upadhyay

Mifepristone remains within the FDA’s highly restrictive Risk Evaluation and Mitigation Strategies (REMS) drug safety program, which tightly controls medications, despite exhaustive research proving that abortion pills in the first trimester are very safe and effective.

Under the REMS restrictions, healthcare providers also have to register with the drug manufacturer to become certified to prescribe mifepristone, which greatly limits the number of qualified providers and has no medical benefit.

“These certification requirements unfairly limit the pools of prescribers and pharmacies for no good reason,” says Moore.

The American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians have all issued statements opposing the FDA REMS restrictions and certification requirements for mifepristone because they have no basis in medicine and create barriers to time-sensitive abortion and miscarriage treatment.

Moore nevertheless hopes pharmacy distribution will mean more medical providers will be willing to become certified and prescribe abortion pills in the future.

“We are moving this product from what used to be a very niche category with a very small circle of players into the mainstream,” says Moore.

The retail pharmacy chains CVS and Walgreens said they will seek certification to sell abortion pills in states where legally permissible, which will greatly expand access to medication abortion for people in those states.

Moore says pharmacy access is important to normalizing abortion pills and making them more accessible. “Permanently lifting the in-person dispensing requirements and allowing patients to get care by mail after a telehealth visit or at the pharmacy is a step in the right direction,” said Moore. “Today, we celebrate this progress and tomorrow, we’ll continue to work towards a world with no restrictions on medication abortion care.”

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About

Carrie N. Baker, J.D., Ph.D., is the Sylvia Dlugasch Bauman professor in the Program for the Study of Women and Gender at Smith College. She is a contributing editor at Ms. magazine. You can contact Dr. Baker at cbaker@msmagazine.com or follow her on Twitter @CarrieNBaker.