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Access to mifepristone, approved by the agency in 2000, also under microscope.
The possibility of a Supreme Court ruling that overturns Roe v. Wade and ends the national right to abortion also is focusing attention on FDA policies supporting access to the abortifacient mifepristone. So-called medical abortions have expanded in recent years to account for more than half of pregnancy terminations in the US, spurred by expanding by state restrictions on surgical abortions, as well as more flexible FDA policies that permit prescribing of the drug via telemedicine visits adopted during the COVID pandemic.
Mifepristone, or Mifeprex, was approved by FDA in 2000 for use with a second drug, Misoprostol, to provide a safe and effective method to induce a miscarriage. The first drug blocks progesterone production, and the second, which is taken at home, empties the uterus. Adverse events have been sparse when the drugs are used properly during the first 10 weeks of pregnancy. FDA initially limited prescribing of mifepristone to specially trained healthcare professionals (HCPs) and required a consultation in a clinic or doctors’ office and dispensing only by certified pharmacies. Modifications made during the public health emergency permit patients to consult physicians and receive prescriptions via telemedicine visits and to obtain the pills through the mail.1
Such changes now are prompting those states that have limited surgical abortions to also seek curbs on access to the abortion pill. Some 20 states have moved to restrict telehealth prescribing of the medicines and distribution through the mail and to require a real-time patient visit to a doctor. Policies are in flux, though, as legal challenges have blocked state enforcement in many cases.
One troubling result of such state restrictions is that patients and clinics are seeking access to these medicines through foreign online pharmacies. Many of these operators provide generic versions of mifepristone made in India and China that may not be approved by FDA, and delayed shipments can raise issues with safe use of the products.
Patient access to birth control pills has also emerged as another concern related to a Court decision eliminating the protections provided by Roe v. Wade, as anti-abortion activists signal interest in such a move. These widely used medicines still require a visit to and prescription from an HCP, prompting patient advocates to respond with a push for over-the-counter status for the “pill.” Some manufacturers have been conducting studies to support an OTC switch but face regulatory challenges in documenting that patients can use birth control pills safely. And frequent attempts by women to use these drugs to induce an early abortion are sure to prompt opposition to policies that make birth control pills more accessible.
Issues related to mifepristone prescribing and dispensing already are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.2 A rollback of the agency’s more liberal prescribing policy was proposed during the debate, and states continue to consider policies that override FDA regulation of this area.