Recently, the Food and Drug Administration announced that retail pharmacies in the US would be able to receive certification to dispense medication abortion drugs. Greer Donley, Associate Professor at the University of Pittsburgh School of Law, sits down to talk with us about the FDA’s recent changes to regulations around medication abortion, including the current status of access, possible challenges, and how far these new changes really go.  

 

Since the FDA approval of mifepristone—one of two medications currently used in a medication abortion—in 2000, access has been harshly regulated. Usually, FDA-approved medications are easily prescribed by licensed providers and dispensed at a pharmacy, but mifepristone faces additional barriers, including a Risk Evaluation and Mitigation Strategies (REMS) protocol. REMS restrictions are reserved for dangerous medication, and include a certification process for the clinician, requires that the medication be dispensed in person in the clinic, hospital, or medical office, and that patients must fill out a consent form. Every major medical association and major expert in the field has branded REMS restrictions for mifepristone completely unnecessary, as it is an incredibly safe drug to take—safer than Penicillin, Viagra, and Tylenol. 

 

During the pandemic, the FDA temporarily lifted the in-person restriction, as making people physically go pick-up medication abortion pills put them at unnecessary risk of COVID-19 transmission. The Supreme Court overturned this decision, but the Biden administration’s newly elected FDA Commissioner, in response, announced that they would not enforce the in-person dispensing requirement completely. A few weeks ago, the FDA began formalizing this announcement, laying out the reversal of in-person dispensing requirement and the allowance of some pharmacies to dispense medication abortion after a certification process. These changes will not have any effect in states that currently ban abortion, as state laws will stop pharmacies and prescribers from dispensing mifepristone. Even with the formalization of this rule, it is unclear how many pharmacies will go through the certification process to be able to dispense the drug. In addition, once pharmacies do become certified, patients will still need to find a certified provider to write than a prescription, and states will still have to follow state laws that restrict abortion.

 

There is a current legal challenge working its way through district court which would ban access to mifepristone. This case was incited by an anti-abortion group suing the FDA in Texas in an effort to revive the Comstock Act; this act, passed near 150 years ago, bans mailing “obscene materials,” the definition of which is being applied to abortion pills. This lawsuit is completely meritless, yet it is still making its way through district court where the only judges are anti-abortion Trump-appointees. In the U.S., more than 50 percent of abortions are medication abortion, and with Dobbs’ disruption of abortion care, this will be incred

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