On Jan. 3, the U.S. Food and Drug Administration (FDA) changed its regulations to allow retail pharmacies to fill prescriptions for abortion medication, expanding access to the procedure as more states move to ban or restrict it after the U.S. Supreme Court’s overturning of Roe v. Wade last year.
Mifepristone, taken in combination with misoprostol, blocks the hormone progesterone, which is needed for pregnancy to continue. Administered during the first 10 weeks of pregnancy, it is a safe and effective method for terminating a pregnancy. More than half of abortions in the U.S. each year are medication abortions.
Drugs Already Legal, but Not From Pharmacies
In 2000, the FDA approved mifepristone in the U.S. under the Risk Evaluation and Mitigation System (REMS) program. Prior to the rule change this year, only clinics, medical offices, or hospitals could dispense mifepristone, and its use required supervision by a certified health care provider. The American Pharmacists Association, among other organizations, advocated for expanded access to the drug.
While the FDA originally announced the change in December 2021, the revision allowing in-person dispensing of mifepristone and letting pharmacies seek certification to dispense it became official this month.
The long-term effect of the change is unclear, as pharmacies are still subject to the laws of their states — which could restrict their ability to dispense the medication.
Federal Lawsuit Could Endanger Access to Drugs
In November 2022, The Alliance Defending Freedom filed a lawsuit in the U.S. District Court for the Northern District of Texas, seeking to overturn the approval of chemical abortion drugs.
The group alleges that the only way the FDA could have approved chemical abortion drugs was by treating pregnancy as an “illness” and by determining that mifepristone and misoprostol “provide a ‘meaningful therapeutic benefit’ over existing treatment.”
As early as February, the judge in that case could issue a temporary order effectively banning mifepristone while the case is pending. The likelihood of such an order is unknown. While this is the first time the group has brought a lawsuit specifically targeting the approval process for mifepristone, the group has failed on two prior occasions to prevail on similar issues.
What Does This Mean for You?
For now, certified pharmacies under the REMS program can dispense the drug directly to customers. It should be noted that this is not the same as going to a pharmacy for emergency contraception (Plan B) without a doctor’s prescription. The requirement of a prescription for a medication abortion remains unchanged, but patients will no longer have to obtain the drugs in person from a health provider and can instead receive the medication by mail. Major pharmacies like Walgreens and CVS announced an intent to become certified.
Given that mifepristone is more than 97% effective in terminating pregnancies and over 4 million women have used it since its approval, its availability will likely remain an issue as the country tries to navigate the consequences of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization last year.
