Some major pharmacies are planning to dispense abortion pills, but not in every state

Health
Mifepristone and Misoprostol

By Jacqueline Howard, CNN

After a change to US Food and Drug Administration rules, major pharmacy chains CVS and Walgreens say they plan to seek certification to distribute abortion pills where legally allowed.

The FDA said on its website Tuesday that pharmacies that become certified to dispense mifepristone, which may be used in a medication abortion, can do so directly to someone who has a prescription from a certified prescriber.

For the first time, this allows outpatient pharmacies to dispense mifepristone, said Lewis Grossman, a professor of law at the American University Washington College of Law.

But that doesn’t mean all pharmacies will dispense the medication.

“In terms of whether or not that is going to have any impact in states where abortion is banned, I think the answer is probably not,” Grossman said. “I don’t see any real effect there.”

It’s not clear which other pharmacies will seek certification or what impact it will have on abortion access in places where it’s banned or restricted.

“It’s not at all clear that many or all or most pharmacies, or pharmacies in more rural areas, or pharmacies in red states will do so in ways that meaningfully increases access to medication abortion,” Leah Litman, a professor of law at the University of Michigan, said in an email Wednesday.

Also, “mail order pharmacies have already been dispensing pills with the FDA’s permission,” she wrote. “So the possibility of getting medication abortion existed before this latest decision.”

A different standard

In a medication abortion, mifepristone is used with another drug called misoprostol to end a pregnancy. Mifepristone blocks a hormone called progesterone that is needed for a pregnancy to continue. Misoprostol can already be distributed by pharmacies.

In a statement Wednesday, Walgreens said it is “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.”

CVS said in a statement, “We plan to seek certification to dispense mifepristone where legally permissible.”

Honeybee Health, an online pharmacy company that had been supplying and shipping abortion medications, posted on its verified Facebook page Tuesday that it “officially became the first pharmacy certified to dispense medication abortion.”

The online pharmacy can distribute the pills only in states where it’s allowed.

“At the onset of the pandemic, Honeybee Health quickly became the first digital pharmacy to supply and ship medication abortion. We are proud to partner with the majority of telemedicine abortion providers in the US and to work closely with our manufacturer to help set the high standards required for certification in response to the FDA’s adjustment to the REMS program,” the Facebook post says. REMS refers to the Risk Evaluation and Mitigation Strategy program for mifepristone.

But for many pharmacies, it will take some time to review and decide whether to undergo the certification process — and the certification process may be complicated.

“Mifepristone is not the kind of drug for which any kind of pharmacy certification is normally required,” Grossman said. “And this particular pharmacy certification regime seems much more onerous than one would expect for a random drug with a similar safety profile.”

The American Society of Health-System Pharmacists said in a statement that “FDA’s change does not mandate that pharmacies must stock or dispense mifepristone, nor does it supersede any state laws that restrict prescribing or dispensing of the medication.”

Affect on abortion access

There are questions remaining about how the changes might affect the abortion access landscape, Litman said.

“It’s not clear that the latest FDA move means that states couldn’t enforce different abortion restrictions against doctors who prescribe medication abortion, or pharmacists who fulfill prescriptions, or people who take medication abortion to induce an abortion,” she said. Additionally, it’s not clear whether someone living in a state with abortion restrictions can use telehealth services to get a prescription for mifepristone and have it delivered through the mail.

In places where abortion was banned or heavily restricted before the FDA update, it remains banned or restricted, said Elizabeth Nash, a principal policy associate of state issues at the Guttmacher Institute, a reproductive-health nonprofit.

“The FDA’s change in allowing dispensing at pharmacies means that there are more options for access for people in states where abortion is not heavily regulated and abortion rights are protected. Where abortion has been banned, abortion remains banned,” Nash said.

“What we are seeing now is that if a state has banned abortion, then medication abortion is unavailable. And I think we’re going to see how this tension plays out between the FDA’s authority over drugs and devices and the state laws,” she said. “We may see some court cases around this very issue as to FDA’s authority and state law.”

Andrea Miller, president of the advocacy group National Institute for Reproductive Health, praised the FDA’s changes, calling them an “important step forward” in terms of increasing access to abortion medication — but she said there is “an unfortunate reality.”

“The unfortunate reality is that there are more than a dozen states right now where abortion is illegal or close to fully illegal, it is banned. And unfortunately, just like people are forced to do now, it is likely that some people in states where abortion is banned may choose to travel to another state to seek medication abortion,” Miller said.

“We don’t believe that anyone should be forced to travel in that way, and certainly, as this moves forward, there are a lot of very smart lawyers who are looking at the question of how they’ll be incorporated into drugstores and pharmacy chains, and where that can happen — and how these different federal and state provisions interplay,” she said.

The FDA’s pharmacy certification for mifepristone requires pharmacies to track shipments and to keep records of prescribers, recipients and lot numbers of each drug dispensed. This “inhibits the creation of a secondary distribution network for this drug,” Grossman said, such as if people in a state with access send the drug to those in abortion-restriction states.

He asked, “Would a state that was prosecuting somebody for diversion have access to those records? Because if they do, then that is a disincentive to providing it to people in states that are banning it.”

Whether states can enforce restrictive abortion laws against people who “provide, facilitate access to, or obtain medication abortion” to someone in another state or within a state depends in part on a doctrine known as preemption, under which a state law that undermines the purpose or objectives of federal law cannot be enforced, Litman said.

In the current political climate, “it’s far from clear” whether the US Supreme Court would say the FDA’s recent actions “preempt” state laws restricting access to medication abortion, Litman said, or that state laws are preempted to the extent they regulate medication abortion.

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CNN’s Carma Hassan contributed to this report.

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