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.
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“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.”
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.
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.
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.”
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.
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.”
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