The legal questions of if and how the decades-old abortion pill mifepristone can be used are wending their way through the courts.
So far, three decisions have been made. In the first, on Apr. 7, a Texas judge ruled to strip mifepristone of its the U.S. Food and Drug Administration (FDA) approval. In the second, issued the same day, a judge in Washington state said the opposite: that the FDA should keep mifepristone on the market in certain states and was prohibited from blocking access to the drug.
The latest decision on mifepristone, issued Apr. 12, further complicates the issue.
What the new ruling says
The U.S. Fifth Circuit Court of Appeals said that mifepristone could continue to be prescribed and used while the case in the Texas ruling makes its way through the appeals process. The three-judge panel agreed with the U.S. Department of Justice (DOJ) and mifepristone’s drug maker that the drug’s approval from the FDA should remain in place because that approval came more than two decades ago, and the plaintiffs were too late to issue complaints on that approval.
However, the court said that the plaintiffs could challenge other actions that the FDA more recently took to expand access to the drug.
In its decision, the court reinstated limitations on the use of the drug. It put back into place restrictions that the FDA had removed in recent years in order to expand access to mifepristone, including the ability of pharmacies to ship mifepristone through the mail and let people obtain the drug through telehealth and virtual visits. Back, too, are the requirements that only doctors who are certified to prescribe the medication can do so, and that users have to take the drug in the presence of health care professionals. The FDA had also extended the time period in the first trimester during which mifepristone could be used, from seven weeks to 10 weeks of pregnancy. The appeals court reinstated that restriction back to seven weeks. The new restrictions will likely be the focus of the full case that will be heard in coming months.
So while the appeals court decision means that mifepristone remains on the market, access to the drug may be narrowed. And the status of other approved drugs may also hang in the balance. “The Fifth Circuit’s decision—just like the [Texas] court’s— second guesses the [FDA’s] medical experts. If this decision stands, no medication—from chemotherapy to drug, to asthma medicine, to blood pressure pills, to insulin—would be safe from attacks,” Vice President Harris said in a statement. “This lawsuit is the next step to a nationwide abortion ban. The decision severely limits access to mifepristone, standing between doctors and their patients.”
Is mifepristone still available?
Yes. The pills are still available in the same places they were before: a limited number of pharmacies that have been certified to dispense the drug after acknowledging how it should be used. But they can no longer be shipped through the mail. Doctors can still write prescriptions, and people can pick up the pills in person.
What happens next to the legal status of mifepristone?
The DOJ responded to the appeals court decision by asking the Supreme Court to block the appeals court ruling. The Justice Department maintains, as it stated in its appeal, that mifepristone is a “safe and effective treatment” and that removing approval of the drug “would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.”
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Contributor: Alice Park