Pharmacy Fallout Over Medication Abortion Continues

Pharmacy giant Walgreens took the tiger by the tail earlier this month when it issued a policy statement on the medication abortion pill mifepristone. Instead of clarifying matters, the company touched off a firestorm of criticism that has yet to die down. 

Mifepristone under threat

Mifepristone was approved by the U.S. Food and Drug Administration in 2000 for use in terminating a pregnancy. The drug has a proven record of safety and effectiveness, and the FDA has affirmed and expanded access to the drug several times since then. In 2019, for example, the FDA approved a generic version. 

During the COVID-19 lockdowns, the FDA also approved mifepristone for use through telemedicine. On Jan. 23 of this year, the agency revisited the issue and affirmed that mifepristone can be dispensed in person or through the mail by telemedicine up to 10 weeks of pregnancy. Dispensers must be certified by the FDA under its risk evaluation and mitigation strategy (REMS), known as the Mifepristone REMS Program, which standardizes the protocol for using the drug to terminate a preganancy. 

The Joe Biden administration’s Department of Justice has also affirmed that the U.S. Postal Service cannot be prosecuted for delivering mifepristone by mail, even in states that ban or restrict the drug.

The FDA and Justice Department actions are intended to protect access to mifepristone in the wake of Dobbs v. Jackson, the 2022 Supreme Court decision that overturned 50 years of abortion protections under Roe v. Wade, enabling states to enact their own restrictions.

Despite these federal actions, the attorneys general of 20 states have warned Walgreens and other pharmacies that they are breaking the law if they ship mifepristone into their states.

In addition, all eyes are on Texas, where a conservative federal judge, Matthew Kacsmaryk, has agreed to hear a lawsuit that challenges the FDA’s approval of mifepristone 23 years ago. There is no precedent for a single federal judge to overturn a longstanding decision of the FDA. However, court watchers point out that Kacsmaryk is a Donald Trump appointee who is affiliated with the First Liberty Institute, described as a conservative legal Christian organization.

Vox reporter Ian Millhiser is among those noting that Kacsmaryk’s extremist decisions on abortion rights, contraception rights, and LGBTQ+ rights are “poorly reasoned” and riddled with basic errors, making it all the more likely that his decision will go against the FDA.

Why Walgreens?

Against this backdrop, Walgreens decided to clarify its position on mifepristone. “Walgreens plans to dispense [mifepristone] in any jurisdiction where it is legally permissible to do so," the company said in a statement dated March 6.

But legality on this issue is increasingly murky, and someone at Walgreens may have failed to do their homework. Though 20 state attorneys general wrote a letter to pharmacies threatening legal action over mifepristone, not all of them represent states that ban the drug.

On March 11, reporter Nathaniel Weixel of The Hill cited a Walgreens spokesman, who said the company responded to all of the attorneys general to let them know that Walgreens will not dispense mifepristone in their states, whether in person or through the mail.

That group includes AGs representing Alaska, Iowa, Kansas and Montana. Though abortion medications have been challenged in some of those states, the restrictions are currently suspended or permanently blocked in court, Weixel reported. Attorneys general from those states clearly overstepped their authority. Nevertheless, to critics it seemed like Walgreens had knuckled under. 

To make matters worse, as of this writing none of the other leading pharmacies in the U.S. have taken a public position on mifepristone, including Albertsons, Costco, Kroger and Walmart, as well as CVS. That leaves Walgreens to bear the brunt of criticism alone, including the loss of a $54 million contract with the state of California, where Gov. Gavin Newsom has pushed back aggressively against Walgreens’ apparent stance. 

Democratic members of Congress also turned up the heat. On March 7, Sen. Elizabeth Warren of Massachusetts wrote a letter to Walgreens seeking clarification on the March 6 statement, including whether or not the company’s policy on mifepristone was informed by medical experts and reviewed by its board of directors.

Help is on the way...?

Confusion aside, Walgreens' statements indicate it still intends to obtain FDA certification through the REMS program. “Once we are certified by the FDA, we will dispense this medication consistent with federal and state laws," the March 6 statement reads. CVS has also indicated it plans to be certified. That laid the groundwork for the threatening letter sent by the 20 anti-mifepristone attorneys general.

But those AGs aren't alone. Another coalition of 23 state attorneys general has since formed to support pharmacies like Walgreens and CVS in their decision to seek FDA certification. In their own letter, they reassure pharmacy companies that they are on solid legal footing. 

“According to these anti-abortion states, ‘[a]bortion pills are far riskier than surgical abortions’ and providing this medicine 'increase[s] . . . coerced abortions.’ These claims are utterly false," their letter reads. “In a time when access to abortion is under attack — now more than ever in the past 50 years — we stand in full support of pharmacies like Walgreens and CVS becoming FDA-certified to dispense and mail these essential medications and to make them available as broadly as possible."

This represents a potentially broad and powerful pool of support for pharmacies like Walgreens. In addition to the economic powerhouses of California and New York state, the pro-mifepristone coalition includes Arizona, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont and Washington.

Kacsmaryk's decision could throw all pharmacies into a public relations nightmare, not just Walgreens. However, Walgreens did put itself out there all alone, and now it must weather the consequences. A hearing in the case is scheduled for Wednesday, March 15.

Image credits: Gayatri Malhotra and Kateryna Hliznitsova via Unsplash