Now that a Texas judge has ruled that the U.S. Food and Drug Administration (FDA)’s approval of the abortion pill, mifepristone, is suspended, what happens to the supply of the drug?
The judge gave the Department of Justice (DOJ), which represents the FDA, until Apr. 14 to file an appeal before the suspension of the drug takes place. Both the DOJ and the drug’s maker, Danco, have filed appeals asking the Fifth Circuit Court to issue a stay on removing the drug’s approval.
Making things more complicated, soon after the Texas judge’s ruling, a district court judge in Washington issued an opposing decision: that the FDA should keep mifepristone on the market and was prohibited from blocking access to the drug. That decision was in response to a lawsuit filed by attorneys general in 17 states and the District of Columbia who questioned the FDA’s requirement that doctors who prescribe mifepristone and pharmacies who dispense it be certified.
If the appeals court does not grant a stay on the Texas judge’s decision in time, the drug would technically no longer be approved. But because no judge has called for the suspension of the FDA’s approval before, experts are divided over what that means for mifepristone.
The FDA’s options
Some think the FDA might have what’s called “enforcement discretion,” which legal experts are interpreting in different ways. Some believe this discretion allows the agency to decide not to enforce the judge’s order to suspend approval of the drug. In that case, the FDA would notify the manufacturer that it was providing safe harbor for the company to continue making and distributing the drug, says Sonia Suter, professor of law and director of the health law initiative at George Washington University. A 1985 Supreme Court decision supports such an action, stating that the FDA has broad enforcement discretion.
Others aren’t confident that the agency’s enforcement discretion applies in this situation, noting that it’s meant more for the FDA to modify its own rules and regulations when circumstances warrant. A recent example of such a situation occurred in 2021, when the FDA removed the restriction on mifepristone that required patients to get the medication in person from a certified health care provider.
What happens to mifepristone that’s already in clinics and doctors’ offices?
Doctors and clinics that currently have supplies of the drug will be looking to the FDA to determine what they do with their doses. But there is no precedent for what happens to drugs when it’s not the FDA—but a judge—that decides they are no longer approved.
If the agency does follow the judge’s ruling and declares mifepristone no longer an approved drug, then “it is technically unlawful to prescribe or dispense a drug that isn’t authorized or approved by the FDA,” says Lawrence Gostin, director of the World Health Organization Collaborating Center on Public Health Law & Human Rights at Georgetown Law.
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But Kirsten Moore, director of the EMAA Project, an organization that helps expand access to medication abortion, believes doses already in the hands of health care providers could still be prescribed and dispensed. Because the Texas judge did not specify any action that the FDA had to take, such as removing the drug from the market, she says, those doses could be used. She points to a precedent from a recent FDA decision to withdraw approval of Makena, a drug that prevents premature birth, based on additional evidence that the medication wasn’t effective. In revoking its approval, the agency said “some health care providers might continue to prescribe or administer that limited remaining supply to their patients,” although the FDA urged doctors to consider the agency’s decision that the risks outweighed the benefits of doing so.
“The Makena example gives us some information that once a drug is in interstate commerce, it’s considered still there,” says Moore.
Removing a drug from the market is a highly regulated process that is laid out in the FDA’s statute. It requires the FDA commissioner and the Secretary of Health and Human Services to issue withdrawal notices, provide the reasons for the withdrawal, and give the manufacturer time to respond to those reasons. Having a judge suspend approval of a drug “is not what the statue requires for withdrawal of a drug,” says Suter. “It’s not the right process.”
Access to mifepristone may depend on what state you live in
Some states are not taking any chances on what might happen to the availability of mifepristone, which is used not just for abortions but also to manage miscarriages. Massachusetts has already ordered 15,000 doses of mifepristone, enough to treat a typical number of patients in the state for a year. California has purchased 2 million pills of misoprostol, an FDA-approved drug for treating ulcers that is used off-label to induce abortions early in pregnancy in combination with mifepristone. Used alone, it can also induce an abortion, although it causes more side effects and the two medications together are more effective. Misoprostol is poised to become the backup plan for medication abortions as the courts continue to debate the status of mifepristone.
In the 18 jurisdictions affected by the Washington ruling, says Suter, doctors may have more confidence in continuing to prescribe mifepristone even if the appeals court does not issue a stay on the Texas judge’s decision.
“Doctors could be bold and think, ‘I have one authority supporting me to continue prescribing the drug, so I will risk it,’” says Suter. “Or they could be conservative and decide it’s too confusing and switch to the alternative of misoprostol.” Given the uncertainty, many providers may err on the side of caution and be more reluctant to prescribe mifepristone for fear of being sued or losing their license if their state licensing boards view the abortion pills as an unapproved drug.
Can you order mifepristone online?
Online access to abortion pills may also be narrowing. In his ruling, the Texas judge invoked the Comstock Act, an 1873 law that prohibits sending any “instrument, substance, drug, medicine or thing” that could be used for abortion. In a 2022 opinion, however, the DOJ clarified that it was not illegal to send abortion medications by mail as long as the sender “lacks the intent that the recipient of the drugs will use them unlawfully.” Still, in his ruling, the Texas judge cited Comstock with a strict reading of “intent,” opening up the possibility that sending mifepristone by mail to any state, regardless of whether the state bans or allows abortion, would be illegal.
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That could make medication abortion less convenient for everyone, even for those in states where abortion is legal. People in those states can currently have a telehealth visit and get a prescription sent to a mail-order pharmacy and then delivered to their home, but soon they may now have to go in person to obtain the pills, since mailing them could be illegal.
U.S. residents could still order mifepristone from overseas, since the Comstock Act does not apply to non-U.S. providers. Aid Access, a Europe-based provider of abortion pills, ships medications from abroad for those who live in states where abortion is banned, and from U.S. sites for those who live in states where abortion is allowed.
While current abortion laws in states only criminalize providers of abortion in the U.S., if current anti-abortion political and judicial pressures continue, Suter says “the next move would be to criminalize the behavior of the patient.” Already, she says, prosecutors in some states have gotten creative with their tactics, including by using child abuse and neglect laws, to hold women who use self-induced abortions accountable.
For now, health providers and legal scholars are waiting for the decision of the appeals court to determine how the right to medication abortions will change. Many states and health providers were turning to abortion pills as a solution to the narrowing availability of abortion procedures in U.S. states; for women who don’t have easy access to surgical abortions, the combination of mifepristone and misoprostol provided a safe and reliable alternative.
“Mifepristone was something that was going to help relieve some pressure on clinics in states where abortion is still legal, because those clinics were seeing a big influx of patients from states where abortion is banned,” says Liz Borkowski, managing director of the Jacobs Institute of Women’s Health at the Milken Institute School of Public Health of George Washington University. “We were hoping access was about to improve in states where abortion is legal. But this could actually reverse that.”
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