FDA on Tuesday finalized a rule allowing retail pharmacies, including large chains and mail-order companies, to offer abortion medication—potentially expanding access to the drug for patients around the country.

The federal government expands access to abortion medication

Mifepristone is a medication that blocks a hormone necessary for pregnancies to develop and is the first drug in a two-part medication abortion regimen. FDA first approved it in 2000 to be taken in the first 10 weeks of a pregnancy. Originally, the drug could only by dispensed by clinics, medical offices, hospitals, or under the supervision of a certified health provider.

During the pandemic, FDA expanded access to the drug by allowing providers to prescribe it through telehealth and allowing certified mail-order pharmacies to send it to patients. In December 2021, the agency moved to make this change permanent.

On Tuesday, FDA finalized a rule that will allow retail pharmacies, including chains and online pharmacies, to offer abortion medication after going through a certification process. Under the change, patients will still need to obtain a prescription from a certified health provider and complete a consent form, but any pharmacy that becomes certified will be able to offer the drug.

"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," said Danco, the company that manufactures Mifeprex, a branded version of mifepristone.

Separately, the Department of Justice (DOJ) on Tuesday cleared the U.S. Postal Service to deliver abortion medication to states that have strict abortion laws. DOJ also offered limited assurances that a federal law on the issue will not be used to criminally prosecute people who mail the medication.

In a legal opinion, DOJ's Office of Legal Counsel (OLC) concluded that a statute aimed at fighting "vice" through the mail cannot be enforced against the mailing of abortion medication if the sender doesn't know if the drugs will be used illegally.

"There are manifold ways in which recipients in every state may use these drugs, including to produce an abortion, without violating state law," said Chistopher Schroeder, OLC chief. "Therefore, 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."

What does this mean for patients?

Following FDA's regulatory change, access to abortion medication in retail pharmacies will be limited to certain states. Currently, more than a dozen states ban abortion, and pharmacies in those states will not be able to get certified and offer the drug.

Both Walgreens and CVS on Wednesday announced they will begin offering abortion medication following FDA's rule.

"We are working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network in terms of where we normally dispense products that have extra FDA requirements and will dispense these consistent with federal and state laws," a spokesperson for Walgreens said.

Similarly, a spokesperson for CVS said the company plans to seek certification to dispense mifepristone "where legally permissible."

Meanwhile, Rite Aid spokesperson Catherine Carter said the company is reviewing FDA's rule and will comply with federal and state laws.

According to a Danco official, it may be easier for small pharmacies or retail pharmacies on hospital campuses to get certified and implement the necessary privacy requirements to offer the drug. More health care providers may also choose to become prescribers since they would not have to stock the medication themselves.

"For some people, this is going to be a huge improvement on their ability to access the drug and be able to even consider this as a choice for themselves," the Danco official said. "For other people, not necessarily. Maybe they don't want to go into their small mom-and-pop pharmacy. They'd rather receive it from a mail order where there's just no interaction that way."

In a statement, the American College of Obstetricians and Gynecologists said the rule change was an "important step forward."

"Although the FDA's announcement today will not solve access issues for every person seeking abortion care, it will allow more patients who need mifepristone for medication abortion additional options to secure this vital drug," the group said. (Belluck, New York Times, 1/3; Perrone, AP/STAT, 1/3; Gonzalez, Axios, 1/4; Ollstein/Gardner, Politico, 1/3; Gonzalez, Axios, 1/3; Whyte, Wall Street Journal, 1/3; Gerstein/Ollstein, Politico, 1/3; Gonzalez, Axios, 1/4; Schulz, USA Today, 1/4)