Updated April 13 at 11:30 a.m. PT.
UPDATE: Late Monday, the Food and Drug Administration (FDA) lifted the in-person dispensing requirements on mifepristone—one of the medications used for medication abortion—until the end of the COVID-19 pandemic. The decision will allow providers in some states to prescribe the abortion pill via telemedicine and send pills via mail.
The announcement was made by way of a letter sent to American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medication and signed by Janet Woodcock, acting FDA commissioner.
Citing four medical reports, the letter reads:
“These studies do not appear to show increases in serious safety concerns … occurring with medical abortion as a result of modifying the in-person dispensing requirement during the COVID-19 pandemic.”
Reproductive health advocates are celebrating the change but are increasing calls for the in-person requirements to be lifted permanently.
“The decision by the FDA to lift the medically unnecessary restrictions on mifepristone until the end of the global public health crisis is in line with what our community of physician advocates knows to be true and has known to be true before the pandemic: Abortion care is safe, and restrictions on abortion care only harm people accessing this essential care,” said ob-gyn Dr. Kristyn Brandi, board chair of Physicians for Reproductive Health, in a statement.
“This is not an end-all solution. These restrictions should be lifted permanently and we will continue pushing the Biden administration to make this a reality so that no matter your race, income, gender, sexuality, age or zip code, people have equitable access to abortion care.”
In the last year, the COVID-19 pandemic has exacerbated existing inequities to abortion care across the country. Last spring, at least 11 states attempted to exploit the crisis to enact additional abortion restrictions, falsely labeling it non-essential care.
In an attempt to ease abortion access during the pandemic, a federal judge in July 2020 halted the in-person dispensing requirement for the abortion pill to allow patients to receive it by mail. However, this was reversed by the Supreme Court’s decision in January 2021 to once again enforce federal restrictions and clamp down on access to this critical medicine.
It is time for the Biden administration to begin fixing these inequities by ensuring that federal policies do not hinder but instead help make the abortion pill more accessible. The science clearly shows that the abortion pill can be safely provided by mail, as was recently demonstrated in a large study from the United Kingdom, where policy changed to allow this practice during the COVID-19 pandemic. The administration can do even more to expand access in the U.S.: Allow pharmacists to dispense the abortion pill.
Medication abortion, also known as the abortion pill, involves a combination of two medicines—mifepristone and misoprostol. The Food and Drug Administration (FDA) requires that mifepristone only be dispensed by certified health care providers—in clinics, medical offices or hospitals.
The FDA imposed these restrictions when it first approved the drug in 2000, and they are currently codified in the drug’s Risk Evaluation and Mitigation Strategy (REMS). Under the REMS, the FDA prohibited retail pharmacies from dispensing mifepristone. Despite mifepristone’s stellar safety record, these restrictions remain in place more than two decades later.
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In 2019, we published a survey of obstetrician-gynecologists (ob-gyns) to see how many provided abortion care and why or why not. One reason ob-gyns did not offer medication abortion is that they do not want to stock the abortion pill in their clinics. Based on responses to the survey, we estimated the number of ob-gyns providing medication abortion would double if they could write a prescription for the pills instead—just like they do for other comparably safe medications. This increase in the number of providers would undoubtedly improve access to medication abortion, since people who do not live near an abortion provider or clinic could instead access this care through an ob-gyn, or really any health care provider trained to offer the service.
But how would this actually work? Will pharmacists be willing to dispense mifepristone? Will patients get enough information? Will it be safe and effective? Following this survey, we decided to answer these questions and look at how pharmacy dispensing of mifepristone compares to in-person dispensing when it comes to safety, effectiveness and patient satisfaction. On all counts, it came out with flying colors.
In our study, over 260 patients were seen in clinic and then stopped by a nearby pharmacy to pick up their abortion pill and other medicines. Patients picked up the medications at the pharmacy from trained pharmacists and took the medications at home. They received standard follow-up care with the clinic afterward.
What we found was that the vast majority were satisfied with the process and felt informed about the medication—either from the healthcare providers in the clinic or the pharmacist. Ninety-three percent of patients had a complete abortion, and none had an ongoing pregnancy—similar to the outcomes you would see if the medicine was dispensed in the clinic. Patients experienced no bad reactions or complications because of receiving the medication at a pharmacy. In fact, over 90 percent of the patients supported pharmacist dispensing of mifepristone.
This research shows that pharmacists can safely dispense the abortion pill and patients are satisfied with this model of care. In several countries, including Australia and Canada, pharmacists already dispense mifepristone on prescription. Making mifepristone available through pharmacies can improve abortion access—especially in rural or other areas where abortion providers and clinics are remote or unavailable. And federal action can make this a reality.
Pharmacists are extremely well-trained health care providers conveniently found in our neighborhood pharmacies, drugstores and even grocery stores. Before pharmacists are able to practice, they earn a doctorate degree and some choose to undergo a residency training program post-graduation.
As the medication experts, pharmacists already play a critical role in health care delivery by dispensing much needed medicines like birth control and now, administering COVID-19 vaccines. There is no reason to prevent them from dispensing mifepristone as well. It’s time for the FDA to remove the restriction on this medicine and start making abortion care more available to all.
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