Health & Science

Abortion drug mifepristone allowed to stay on market, but with hefty restrictions, ruling says

While the order would keep the drug on the market, it would limit use to 7 weeks into pregnancy or less and prohibit sending the pills to patients in the mail.


Mifepristone is the first pill typically given in a medical abortion.

Wednesday night, the U.S. 5th Circuit Court of Appeals issued a ruling keeping the abortion drug mifepristone on the market but with hefty restrictions. Experts expect the ruling to impose further obstacles to already limited abortion care options for people in states with abortion bans.

The order is the latest development in a legal saga that started nearly a week ago when Judge Matthew Kacsmeryk of Amarillo ruled to suspend the Food and Drug Administration's approval of the abortion medication. He cited "psychological effects" he said the FDA failed to consider.

The drug, mifepristone, is the first pill in a two-step regimen commonly prescribed for abortions up to 10 weeks into pregnancy. It has been on the market for over 20 years, and all major medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, attest to its safety. Many medical experts say Kacsmeryk based his ruling on "junk science."

The three-judge panel in New Orleans ruled around midnight last night to allow the ruling to take effect, except for the provision suspending FDA approval all together. While the order would keep the drug on the market, it would limit use to 7 weeks into pregnancy or less and prohibit sending the pills to patients in the mail.

Elizabeth Sepper, a law professor at the University of Texas at Austin said the ruling reinstitutes previous restrictions on the medication.

"Under the fifth circuit decision, the status of mifepristone reverts back to pre-2016," she said. "That requires three in-person visits in order to prescribe the medication and doesn't allow telehealth, basically." This includes provisions prohibiting mailing the prescription.

For residents of Texas and other states with near-total abortion bans, receiving abortion medication in the mail in one of the few avenues left for accessing abortion care. However, Sepper said she believes patients will largely still be able to access the medication via organizations who send it from outside the U.S.

“In terms of whether this ruling necessarily impacts people who are seeking abortion pills from Aid Access, Plan C or the like, I’d say the answer is no," she said. "Who this could affect are, say, women who are leaving the state to receive a legal medication abortion in New Mexico, for example, where medication abortion may become more limited.”

Not only will patients who attempt to leave the state for a legal, medication abortion have a shorter window in which to do so — 7 weeks as opposed to 10 — but they also will likely need to go to several in-person appointments with a physician before they can receive a prescription.

Meanwhile, minutes after Judge Kacsmeryk's decision came down in Amarillo last Friday, a federal district court judge in Washington state, Judge Thomas Rice, issued a contradictory ruling requiring the FDA to maintain current procedures and access to the drug in 17 states where abortion is legal as well as Washington, D.C., including access by mail.

This leaves the FDA between the proverbial rock and a hard place, as it is up to the FDA, Sepper said, to figure out how to reconcile the dueling decisions.

"The FDA has enforcement discretion," said Sepper. "For example, when we have drug shortages and people seek to get access to drugs from Canada, those are non-FDA-approved drugs, but the FDA has often allowed importation of certain drugs in order to facilitate access to medication in the United States."

As a result, Sepper said the FDA could choose not to enforce the restrictions on mifespristone as part of its enforcement discretion.

Today, the U.S. Department of Justice announced its request for the Supreme Court to intervene in the emergency dispute.

"We will be seeking emergency relief from the Supreme Court to defend the FDA's scientific judgment and protect Americans' access to safe and effective reproductive care," Attorney General Merrick Garland said.

Sepper said the Justice Department is essentially requesting an emergency administrative stay on the 5th Circuit ruling.

"What the DOJ wants from the Supreme Court is going to be an order to the 5th Circuit not to allow the ruling to go into effect, with regard to mifepristone," she said.

Without action from the Supreme Court, the ruling will go into effect at the end of the day Friday.

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