FDA Won't Enforce Trump-Era Restrictions On Dispensing Abortion Pills By Mail
The agency concluded there was no increased risk to allowing patients to access abortion pills through telemedicine or the mail.
The Food and Drug Administration (FDA) won’t enforce restrictions on dispensing abortion pills via telemedicine or by mail during the coronavirus pandemic, key stakeholders revealed Monday. The move effectively reverses a Trump-era policy that sought to increase patients’ burden in accessing abortion care during the pandemic by requiring anyone seeking a medication abortion to visit a hospital, clinic, or doctor’s office in person in order to obtain mifepristone, one of two drugs used in conjunction to induce a medication abortion.
In a letter outlining the FDA’s decision to the American College of Obstetricians and Gynecologists (ACOG) — an organization that challenged the dispensing requirement last year — acting FDA Commissioner Janet Woodcock noted the FDA’s Center for Drug Evaluation and Research (CDER) had reviewed all applicable studies. They found no study demonstrated an increase in serious safety concerns pertaining to medication abortions as a result of modifying in-person dispensing requirements. As a result, Woodcock said the federal agency would not enforce in-person dispensing requirements for the abortion pill through the pandemic.
“Given that the in-person dispensing of mifepristone for medical termination of early pregnancy may present additional COVID-related risks to patients and healthcare personnel because it may involve a clinic visit solely for this purpose, [the FDA’s Center for Drug Evaluation and Research] CDER intends to exercise enforcement discretion during the COVID-19 [public health emergency] PHE with respect to the in-person dispensing requirement,” the Woodcock wrote in her letter. “Further... CDER intends to exercise enforcement discretion during the COVID-19 PHE with respect to the dispensing of mifepristone through the mail.”
When the FDA refused to drop in-person dispensing requirements for mifepristone — a drug the agency approved as “safe and effective” more than 20 years ago — early in the COVID-19 pandemic, the American Civil Liberties Union (ACLU) sued the Trump administration on behalf of ACOG and other reproductive rights groups. Court documents obtained by The New Yorker showed reproductive rights groups and the ACLU argued those in-person dispensing requirements disproportionately impacted low-income people and people of color, two groups found to have a higher risk of experiencing serious illness or death as a result of COVID-19.
But although a lower court ruled in the ACLU’s favor last year, effectively suspending in-person distribution rules for mifepristone during the pandemic, a Supreme Court ruling handed down in January reinstated those restrictions.
In a statement shared over Twitter late Monday, ACOG applauded the FDA’s recent decision to exercise enforcement discretion in regards to mifepristone. “This means that many patients in need of termination of early pregnancy will be able to access safe, effective mifepristone by mail, rather than having to risk avoidable COVID exposure to themselves and their clinicians,” the organization said. “[ACOG] has long advocated for the [FDA] to drop the burdensome in-person dispensing requirement for mifepristone, which provides no benefit to patients. We applaud the agency for prioritizing science over politics.”
Similarly, The Society for Maternal-Fetal Medicine called the decision “a win for abortion access.”
But the FDA’s decision only applies to the enforcement of dispensing requirements during the ongoing COVID-19 pandemic and it remains unclear how the Biden administration might handle mifepristone once the pandemic has ended. Doctors and reproductive rights organizations like the Guttmacher Institute have long advocated for a permanent end to the current restrictions on abortion pills.
“This is a long overdue first step, but it’s far from enough,” the Guttmacher Institute said in a statement shared over Twitter. “[The FDA] should now review all the restrictions it currently places on abortion pills in light of the full body of scientific evidence and real-world use, and modify or remove them accordingly. The scientific evidence is clear: #MedicationAbortion is safe and effective, and has a stellar track record of more than 20 years of use in the United States.”