The impact of the Food and Drug Administration’s decision to allow pharmacies to dispense abortion pills may be far more limited than abortion advocates, and the Biden administration, had hoped for.
Since the agency’s announcement three weeks ago, a trio of major pharmacy chains — Walgreens, CVS and Rite Aid — has said they would apply to dispense the medication, mifepristone, in at least some states where abortion is legal. But several other retail pharmacies, including those run by grocery stores like Kroger or Wegmans, have not announced their plans publicly and did not respond to Grid’s questions on the matter — suggesting the pills may not be widely available at the nation’s pharmacies despite soaring demand.
The rule change and its aftermath highlight the contradictory legal landscape around medication abortion in the United States. The FDA has approved the pills for abortions up to 10 weeks, and in 2021, it repealed a requirement that mifepristone be given in doctor’s offices or other medical facilities. But at least 13 states have banned most abortions, including those via medication, and another 18 have laws requiring prescribing clinicians to administer mifepristone in person.
Pharmacies may be reluctant to apply for certification until the legal picture becomes clearer through litigation, which could take years. In the meantime, abortion opponents — including a group involved in the Dobbs case that ended the national right to abortion — are suing to overturn the FDA’s approval of mifepristone and misoprostol, the other drug used in medication abortion, which could imperil access nationwide.
“The fact the FDA made some of these changes is a big deal for expanding medication abortion access,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project. “But we knew this would have a limited impact in a post-Dobbs landscape,” she said. “It’s frustrating, because states have never before blocked access to an FDA-approved drug.”
Loosened, but still restricted
Mifepristone, the first in a two-drug regimen for medication abortions, blocks a hormone necessary for pregnancy to develop. The FDA approved it in 2000, but with caveats. The drug could be dispensed only in person at a healthcare clinic or hospital by a certified provider. (The second drug, misoprostol, is used for many other medical conditions and has never been tightly regulated.) These caveats, known as Risk Evaluation and Mitigation Strategy, or REMS, are an FDA tool to control how certain drugs with risks for misuse — such as narcotics — can be dispensed.
Many physicians argue these restrictions are unnecessary for mifepristone, which has been shown to be safe and effective and doesn’t have the risk of abuse of other drugs with REMS.
In December 2021, the FDA relaxed its requirement that mifepristone be dispensed in person, allowing the pills to be distributed via telemedicine. On Jan. 3, the agency updated its rules further, allowing retail pharmacies to dispense mifepristone if they apply for certification. Both moves were met with praise from many physicians and advocates of abortion care, but also calls for the FDA to do more.
“These are important steps in normalizing medication abortion, which should be treated like any other medical care,” said Ushma Upadhyay, a public health social scientist at the University of California, San Francisco. “Being able to pick up a prescription at your local pharmacy, that would really make abortion care less stigmatized and more accepted as a real option for people.”
Making mifepristone more widely available at pharmacies could help increase access at a time when abortion care deserts are widening in the United States. “Clinics in states geographically close to states that have banned abortion are being inundated right now, sometimes turning away patients who are further along in their pregnancy,” Upadhyay said. Allowing pharmacies to distribute abortion medication could help alleviate some of this stress by spreading out access, she said.
But experts told Grid that pharmacies are unlikely to try to dispense these drugs in states with restrictions until the preemption question becomes clearer. And the process of certification itself may dissuade some pharmacies from providing these drugs in states where abortion remains legal.
Getting certified “is not super complicated, but it can be intimidating,” said Upadhyay, especially for smaller pharmacies. To dispense mifepristone, pharmacies must attest to having systems in place for tracking shipments of the medication, ensuring that the clinicians prescribing mifepristone are themselves certified, and keeping patient and provider information confidential.
Larger chains like CVS and Walgreens “already have these types of processes in place for other drugs,” said Rachel Rebouché, a law professor at Temple University. But such systems can be costly, and this requirement “might chill smaller pharmacies, or those that don’t already have these processes in place, from applying for certification,” she added.
CVS, Walgreens and Rite Aid have all said they plan to distribute pills, but only at a limited number of stores in accordance with state and federal laws. These companies account for only about 45 percent of total prescription revenue in 2021 from pharmacies. Other major chains, including grocery stores like Hy-Vee, Kroger, Publix, Albertsons and Meijer, did not respond to Grid’s requests for comment. The FDA referred questions about how many pharmacies have applied for certification to the companies that make name-brand and generic mifepristone, Danco Laboratories and GenBioPro.
A Danco spokesperson told Grid that information on pharmacy certifications “isn’t publicly available.” GenBioPro said that Honeybee Health, an online pharmacy, was the first certified pharmacy and that it “is receiving additional pharmacy certification applications,” but declined to specify how many had come in.
“I wouldn’t be surprised if many pharmacies pass on this, for a combination of reasons,” said Moore. “If you’re a small, independent pharmacy, you may just not want to take this on.”
One reason may be avoiding controversy. Anti-abortion activists plan to picket outside some CVS and Walgreens stores early next month to protest their decisions to dispense the pills. Many pharmacies may not want to wade into this culture war, said Moore. “Pharmacists just want to put their heads down and do their jobs,” said Moore. “They don’t want to get dragged into drama.”
Stores may also want to avoid internal conflict if some employees object to filling prescriptions for mifepristone based on their personal beliefs. Since the Dobbs decision, numerous reports have surfaced of pharmacy employees refusing to dispense birth control for religious reasons, sparking lawsuits in some cases. Pharmacies may just want to steer clear of that controversy by not offering the pills, said Rebouché.
Still, pharmacies may decide to get certified despite these complicating factors. “There’s a real statement here that this is a drug like other drugs we carry, it’s approved by the FDA and we’re going to make it available in states where it’s legal,” said Rebouché.
Whether those efforts will be restricted to states where abortion is currently legal or extended to all based on the FDA’s power to approve drugs nationwide will be ultimately be settled in the courts. Abortion drug manufacturers have raised legal challenges to restrictive state laws in the past, but there are no ongoing lawsuits. On the other side, 22 Republican attorneys general admonished the FDA’s recent rule change in a letter to the agency, setting the stage for future litigation.
The battle over pharmacies will likely be but one of many legal clashes involving medication abortion in the wake of the Dobbs decision, said Rebouché, given the inherent accessibility and portability of these drugs. “The fight around abortion in this country will revolve around abortion pills.”
Thanks to Lillian Barkley for copy editing this article.