In April, the Food and Drug Administration (FDA) enabled reproductive health providers to prescribe mifepristone, the abortion medication, via telemedicine — at least through the duration of the pandemic.

“The FDA removed the onerous and unnecessary restrictions on accessing mifepristone during the pandemic, and this decision protects the health and safety of patients and clinicians,” says Julie Rabinovitz, MPH, president and chief executive officer of Essential Access Health in Berkeley, CA. “It means patients will no longer have to travel to receive medication for abortion care, and it closes inequitable gaps in time-sensitive abortion access. Now, the Biden administration must move quickly to make this policy change permanent. It should not just remain during the pandemic, but it should remain long-term.”

On April 12, the FDA wrote a letter to Maureen G. Phipps, MD, MPH, FACOG, chief executive officer of the American College of Obstetricians and Gynecologists (ACOG). In April 2020, ACOG had asked former FDA Commissioner Stephen Hahn to lift in-person dispensing requirements for certain prescription drugs during the public health emergency.

The letter stated the FDA’s Center for Drug Evaluation and Research had reviewed data on expanding telemedicine abortion services and found no increases in serious safety concerns, such as hemorrhage, ectopic pregnancy, or surgical interventions.1

“The FDA will exercise enforcement discretion about in-person [prescriptions],” Rabinovitz says.

As long as other requirements of the mifepristone Risk Evaluation and Mitigation Strategy are met, the FDA approved lifting the requirement of in-person dispensing of mifepristone, since the COVID-19 pandemic presents additional COVID-related risks to patients and healthcare personnel when patients visit a clinic solely to receive a prescription of mifepristone, said the letter, signed by FDA Acting Commissioner Janet Woodcock, MD.1

Within a few days of the FDA’s letter on telemedicine mifepristone, a physician from Seattle launched an online platform called Abortion on Demand. Women can make virtual appointments to obtain the abortion pills through a mail-order pharmacy.2,3

Women complete a secure questionnaire to make an online appointment. The medication is mailed in a discreet package. They follow instructions for the pills, then they receive a follow-up text message. If they experience any problems, 24/7 physician support is available. The service costs $239 and requires clients to produce a photo ID, a positive pregnancy test, and to be less than eight weeks since their last period. They also must be at least 18 years of age and live in one of the 20 participating states, and Washington, DC, eligible for the service. Georgia is the only eligible Southern state, and Illinois is the only eligible Midwestern state, although the website notes that Michigan and Pennsylvania will be eligible soon.3

According to the physician who founded Abortion on Demand, Jamie Phifer, MD, the first women to use the service live in places where they cannot easily access abortion providers, or they have child care issues that make traveling to a provider challenging.2

The FDA’s action is temporary, depending on the length of the pandemic and whether the Biden administration lifts the in-person requirement permanently. “Clearly, this administration is committed to evidence-based medicine and science,” Rabinovitz says. “But there’s no scientific or medical justification for requiring women to travel to a hospital, clinic, or medical office to pick up their medications.”

Extensive evidence and expert analyses have shown that mifepristone is safe when prescribed through telemedicine. “This decision is welcome. It’s definitely long overdue, and needs to be permanent,” Rabinovitz says. “The harm of these regulations falls hardest on people of color, those who live in rural areas, and those who are struggling to make ends meet. We believe the administration has an opportunity and obligation to ensure individuals across the country have access to the early abortion care they need, without delay.”

One potential obstacle to continuing these prescriptions is the Jan. 12 U.S. Supreme Court decision in FDA v. American College of Obstetricians and Gynecologists, in which the court ruled in favor of requiring the abortion pill to be picked up in person, even during the pandemic, according to a recent perspective paper. The authors noted the actual ruling is moot because the FDA’s April 12 action nullifies it, but that the court’s decision includes troubling stealth logic.4

As the paper notes, when the pandemic made it difficult for people to pick up medications at pharmacies, the FDA waived the in-person pickup requirements for controlled substances, including methadone and fentanyl, but did not waive this requirement for mifepristone. Abortion medication was the only self-administered drug that patients could not obtain by mail or a pharmacy drive-through window.4

A federal court had ordered the FDA to exempt mifepristone because patients had to decide between COVID-19 risk or delaying abortions.

The decision’s trap is that it decided the lower court should have deferred to the FDA’s expertise to assess public health, which sets a precedent for courts siding with politicized agencies, such as federal agencies with political appointees, over evidence-based and scientific expertise. The three dissenting liberal justices called the decision a “callous response.”4

REFERENCES

  1. Food and Drug Administration. FDA response to American College of Obstetricians and Gynecologists. ACLU website. April 12, 2021.
  2. McShane J. You can get the abortion pill by mail for now, the FDA ruled. But it’s still an ongoing legal battle. The Lily. April 26, 2021.
  3. Abortion on Demand. https://abortionondemand.org
  4. Fox D, Cole E. The Supreme Court’s abortion exceptionalism — judicial deference, medical science, and mifepristone access. N Engl J Med 2021. doi: 10.1056/NEJMp2104461. [Online ahead of print].