In order to adhere to the requirements of the US Food and Drug Administration (FDA), before prescribing a medications to abort pregnancies in the first 10-11 weeks, physicians have been compelled first to perform a pelvic examination or ultrasound test for pregnancy. These examinations require an in-person clinic visit, which can be burdensome, expensive, and limit access to care. In a recent issue of the AMA journal, evidence is provided that medication abortions using the drugs mifepristone and misoprostol are safe and effective for pregnancy termination and do not require an in-person evaluation. These data provide both physicians and FDA evaluators that allowing questionnaire-based screening in lieu of in-person examinations is appropriate and evidence based.
This report is particularly timely given the FDA’s recently completed review of Mifepristone. On December 20, 2021, the FDA sent a letter to the plaintiffs in a case the American Civil Liberties Union filed in 2017 on behalf of a Hawaiian doctor and health care associations, which argued that the FDA restricted access to abortion care with no medical basis by requiring in-person dispensing of mifepristone. Based on the available data, the FDA decided to remove the requirement for in-person dispensing of these drugs. This does not change current practice because the FDA had previously removed the in-person dispensing requirement during the COVID-19 emergency. While this decision eliminates the in-person dispensing requirement permanently, it does not adjust additional requirements for specialized physician certification, which the FDA left in place. Moreover, the new rules added an additional restriction requiring certification of the pharmacies meant to dispense mifepristone. There are no data available that these certifications of physicians, and pharmacies adds clinical benefit to an already safe and effective medication with limited risks. Moreover, the FDA’s action will not affect existing state-level restrictions on access to medication abortion that are already in place. As a result, communities that already face difficulty accessing medication abortions remain vulnerable to medically unnecessary restrictions.
Many providers of abortion services in the US already support moving toward elimination of in-person requirements. This should allow us to move forward with a plan that meets the highest standards of quality care while ensuring access. Given the evidence, it is our professional duty to recognize, reassess, and eliminate unnecessary barriers to medical care. This is essential to address inequities in access to abortion care that are more likely to affect individuals less able to access care, including communities of color, and those living on low incomes and in rural areas.
Removing the medically unnecessary restrictions and changing the standard protocol for a medically induced abortion will make care more timely, efficient, patient centered, and equitable by removing the need to access a physical clinic. It also has the potential to support the expansion of the workforce of abortion caregivers. As reported in the JAMA journal, the US abortion care workforce includes only 3550 abortion service professionals. According to the Centers for Disease Control and Prevention, this limited workforce provided legally induced abortions for 629 898 people in the US seeking abortions in 2019. The number of providers of abortions can be increased by removing the requirement for them to sign unnecessary documents and through educating clinicians about the safety and efficacy of medication abortion that does not require in-person assessment.
Hopefully, future regulations will be established on a uniform, all encompassing, national level, which will follow the evidence and prioritize our collective principles of quality health care delivery.