A recent decision by the U.S. Supreme Court could make it more difficult for women to access medication abortions.

In an unsigned brief order on Jan. 12, the Supreme Court said a district court should not have compelled the Food and Drug Administration (FDA) to lift a requirement that mifepristone, the abortion pill, has to be picked up in person.1

“The recent Supreme Court decision requires patients to come in person to a facility to receive mifepristone for a medication abortion,” says Daniel Grossman, MD, professor in the department of OB/GYN reproductive sciences and director of Advancing New Standards in Reproductive Health at the University of California, San Francisco. “This requirement, codified in the FDA’s risk evaluation and mitigation strategy [REMS] for mifepristone, had been temporarily suspended during the COVID-19 public health emergency, thanks to a federal judge’s order in July.”

No Medical Reason for In-Person Visit

There is no medical reason to force patients seeking medication abortion to obtain the pills in person. “This requirement puts them at increased risk of exposure to the coronavirus,” Grossman adds. “It also restricts the number of clinicians who can provide medication abortion, since not all stock the drug in their clinics, and it creates an obstacle to care.”

Numerous studies have established the safety of mifepristone, says Julie Rabinovitz, MPH, president and chief executive officer of Essential Access Health in Berkeley, CA. “Acetaminophen, the active ingredient in Tylenol, has a much higher rate of adverse reactions,” she notes.

Research also shows that medication abortion can be provided safety and effectively through telemedicine. “The FDA already permits patients to take the pill at home, but they require clinicians to provide the pill in person in a clinical setting,” she says. “It’s an onerous requirement and puts patients at risk, especially during the pandemic. It maintains many barriers to access to early abortion care.”

Last summer, several organizations challenged this rule in court. A federal judge in Maryland issued a nationwide injunction blocking the FDA requirement that mifepristone be given in a clinical setting, Rabinovitz explains.

“This was particularly important to communities of color and low-income communities suffering from COVID,” she explains. “The government appealed, and [in January] the Supreme Court lifted the injunction and allowed the block to be enforced again.”

New Administration Could Remove Barrier

The new Biden administration could take steps to remove this barrier. “There may be a way for the administration to instruct the FDA to temporarily suspend the in-person dispensing requirement during the pandemic,” Grossman says.

Under the new administration, the FDA could take immediate action to increase access to mifepristone during the pandemic by updating the FDA’s March 2020 guidance on “REMS Requirements During the COVID-19 Public Health Emergency” to include explicit permission to provide remote access to early abortion treatment, Rabinovitz says.

“A group of over 100 congressional leaders called on FDA Commissioner Hahn to do so last summer,” she explains. “It is our hope and expectation that President Biden will direct the FDA to put this temporary fix in place while they work on a longer-term solution.”2

The permanent solution would require an FDA review of evidence. “They also could encourage the FDA to review the evidence in-depth to determine whether the mifepristone REMS could be modified or removed permanently,” Grossman says.

A first step would be to form a team of FDA clinical and safety reviewers to determine if REMS requirements are needed. They could seek information from outside experts and patients. “In making the determination, they must consider whether there is a particular risk or risks associated with the medication, and if the risks outweigh its benefits,” Rabinovitz says. “The potential burden of REMS requirements also have to be taken into consideration.”

REMS requirements are not designed to be permanent. “When FDA leaders direct their reviewers to take this critical step, they will find that mifepristone’s benefits clearly outweigh the risks, and that for the advancement of public health, the REMS requirements should be lifted,” Rabinovitz adds. “After the REMS requirements are lifted, widespread coverage and adequate reimbursement for the provision of medication abortion through telehealth across payers has to be the next step.”

This will advance health equity and ensure that patients nationwide can access the early abortion care they want, when they want it, Rabinovitz says.

REFERENCES

  1. Food and Drug Administration, et al. v. American College of Obstetricians and Gynecologists, et al. Supreme Court of the United States. Jan. 12, 2021; 492; No. 20A34. https://www.supremecourt.gov/opinions/20pdf/20a34_3f14.pdf
  2. Letter to Dr. Stephen Hahn, Commissioner, Office of the Commissioner, U.S. Food and Drug Administration, signed by Diane DeGette, Barbara Lee, and other members of Congress. June 16, 2020. https://degette.house.gov/sites/degette.house.gov/files/Mifepristone%20Letter%20to%20FDA_6.16.2020.pdf