What Happens Next in the Fight Against Abortion Pills
NOTow that a judge in Texas has ruled that the United States Food and Drug Administration (FDA) approval of abortion pill, mifepristone, suspendedwhat happens to the drug supply?
The judge gave the Department of Justice (DOJ), which represents the FDA, until April 14 to file an appeal before the suspension of the drug takes place. The DOJ and the drug’s maker, Danco, have filed appeals asking the Fifth Circuit Court to issue a stay on the removal of the drug’s approval.
To complicate matters, shortly after the Texas judge’s ruling, a Washington District Court judge ruled to the contrary: that the FDA must keep mifepristone on the market and that it was prohibited from blocking it. access to medicine. The move followed a lawsuit by attorneys general from 17 states and the District of Columbia that challenged the FDA’s requirement that physicians who prescribe mifepristone and pharmacies that dispense it must be certified.
If the appeals court does not grant a stay of the Texas judge’s decision in time, the drug will technically no longer be approved. But since no judge has asked for the FDA’s suspension of approval before, experts are divided on what that means for mifepristone.
FDA options
Some think the FDA might have what is called “enforcement discretion,” which legal experts interpret in different ways. Some believe that this discretion allows the agency to decide not to enforce the judge’s order to suspend the drug’s approval. In this case, the FDA would notify the manufacturer that it was providing a safe haven for the company to continue manufacturing and distributing the drug, says Sonia Suter, a law professor and director of the Health Law Initiative at George Washington University. A 1985 Supreme Court decision supports such action, stating that the FDA has broad enforcement discretion.
Others are not convinced that the agency’s enforcement discretion applies in this situation, noting that it is more for the FDA to change its own rules and regulations when circumstances warrant. . A recent example of such a situation occurred in 2021when the FDA removed the restriction on mifepristone that required patients to obtain the drug in person from a certified healthcare provider.
What happens to the mifepristone already present in clinics and doctors’ surgeries?
Doctors and clinics that currently have drugs will look to the FDA to determine what they do with their doses. But there’s no precedent for what happens to drugs when it’s not the FDA, but a judge, who decides they’re no longer approved.
If the agency follows the judge’s decision and declares that mifepristone is no longer an approved drug, then “it is technically illegal to prescribe or dispense a drug that is not cleared or approved by the FDA,” Lawrence says. Gostin, director of the World Health Center collaborating organization on public health law and human rights at Georgetown Law.
Learn more: Why Republicans are going so far in so many states
But Kirsten Moore, director of the EMAA Project, an organization that helps expand access to medical abortion, thinks doses already in the hands of healthcare providers could still be prescribed and dispensed. Because the Texas judge did not specify any action the FDA needed to take, such as removing the drug from the market, she said, those doses could be used. She points to a precedent of a recent FDA decision to withdraw approval of Makena, a drug that prevents premature births, based on additional evidence that the drug was not effective. In revoking its approval, the agency said “some health care providers may continue to prescribe or administer this remaining limited supply to their patients,” although the FDA urged physicians to heed the agency’s decision. agency that the risks outweighed the benefits.
“The Makena example gives us insight into the fact that once a drug is in interstate commerce, it’s considered still there,” Moore says.
Removing a drug from the market is a highly regulated process that is defined in the statute of the FDA. It requires the Commissioner of the FDA and the Secretary of Health and Human Services to issue recall notices, provide reasons for the recall, and give the manufacturer time to respond to those reasons. Having a judge suspend a drug’s approval “is not what the statue requires for a drug’s withdrawal,” Suter says. “This is the wrong process.”
Access to mifepristone may depend on the state you live in
Some states are taking no chances on what might happen to the availability of mifepristone, which is used not only for abortions but also to manage miscarriages. Massachusetts already has ordered 15,000 doses of mifepristone, enough to treat a typical number of patients in the state for one year. California has bought 2 million pills misoprostol, an FDA-approved drug for the treatment of ulcers that is used off-label to induce abortions in early pregnancy in combination with mifepristone. Used alone, it can also cause abortion, although it causes more side effects and the two drugs together are more effective. Misoprostol is about to become the back-up plan for medical abortions as the courts continue to debate the status of mifepristone.
In the 18 jurisdictions affected by Washington’s decision, Suter says, doctors may have more confidence in continuing to prescribe mifepristone even if the appeals court does not stay the Texas judge’s decision.
“Doctors might be bold and think, ‘I have authority backing me to keep prescribing the drug, so I’m going to risk it,'” Suter says. “Or they could be conservative and decide it’s too confusing and move on to the misoprostol alternative.” 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 consider abortion pills as an unapproved drug.
Can you order mifepristone online?
Online access to abortion pills may also be shrinking. In his decision, the Texas judge invoked the Comstock Law, an 1873 law that prohibited the sending of any “instrument, substance, drug, medicine or thing” that could be used for abortion. In a 2022 advisory, however, the DOJ clarified that it was not illegal to send abortion drugs through the mail as long as the sender “did not intend that the recipient of the drugs would use them illegally”. Yet 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, whether the state prohibits or permits the abortion is illegal.
Learn more: What nine months means to a pregnant person
This could make medical abortion less convenient for everyone, even those who live in states where abortion is legal. Residents of these states can currently take a telehealth visit and have a prescription sent to a mail-order pharmacy and then delivered to their home, but they will soon have to go in person to get the pills because mailing them could be illegal.
US residents can still order mifepristone overseas, as the Comstock Act does not apply to non-US suppliers. Access to aida European supplier of abortion pills, ship medicines from abroad for those who live in states where abortion is prohibited, and from US sites for those who live in states where abortion is permitted.
While current state abortion laws only criminalize abortion providers in the United States, if current anti-abortion political and judicial pressure continues, Suter says “the next step would be to criminalize the behavior of the patient”. Already, she says, some state prosecutors have been creative in their tactics, including using child abuse and neglect laws, to hold women who have voluntary abortions accountable.
For now, health care providers and lawyers are waiting for the appeals court ruling to determine how the right to medical abortions will change. Many states and healthcare providers have been turning to abortion pills as a solution the decreasing availability of abortion procedures in US states; for women who do not have ready 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, as those clinics were seeing a large influx of patients from states where abortion is banned,” said Liz Borkowski, CEO of the Jacobs Institute. of Women’s Health at the Milken Institute School of Public Health at George Washington University. “We hoped access would improve in states where abortion is legal. But it could actually reverse that.
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