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Mifepristone, one of two drugs typically used to induce a medication abortion, will remain available for now but with significant restrictions. Those include limiting the drug’s usage to up to seven weeks of pregnancy and barring its distribution by mail.
The U.S. Court of Appeals for the 5th Circuit on Wednesday night put on hold part of a lower court’s ruling to withdraw decades-old Food and Drug Administration approval of mifepristone, which could have effectively banned the drug from distribution. Currently, more than half of all abortions in the United States are medication abortions, according to the latest Guttmacher Institute data.
After the Texas-based federal judge’s decision Friday, the Justice Department quickly appealed. In its filings, the Justice Department argued that withdrawing FDA approval from mifepristone would severely harm patients across the country. They also argued the ruling would allow doctors to challenge FDA approval of any drug or federal action that allegedly injures third parties.
In its decision, the 5th Circuit raised concerns about whether the statute of limitations enabled the plaintiffs to challenge the approval of the drug, which has been approved by the FDA since 2000, but they did consider the plaintiffs’ more timely challenges. For decades, mifepristone was subject to restrictions: The medication could be dispensed by only certified prescribers in clinics, medical offices or hospitals — not pharmacies — and patients had to sign an agreement stating they were warned about potential side effects.
In recent years, regulatory changes started allowing mifepristone to be accessed by a wider range of people. In 2016, the gestation period in which the drug can be used was lengthened to 10 weeks. In April 2021, due to the pandemic, the FDA announced it would allow abortion pills to be mailed to patients. Then, in December 2021, the FDA issued a permanent decision to allow mailing of the pills and expanded access through pharmacies.
These are the same changes that the 5th Circuit struck down in its 42-page order. In a 2-to-1 vote, the court ruled that the drug could be used only up to seven weeks instead of 10, and it can no longer be distributed by mail, raising concerns from abortion rights advocates that it will be much harder to access — particularly for people in states where abortion is banned or severely restricted, who are often traveling out of state to access the procedure.
Since mifepristone was first made available in 2000, it has allowed millions of pregnant people to have access to safe abortions that are often less expensive to perform than surgical abortions.
Clinics that have been flooded with out-of-state patients have leaned on medication abortions to allow them to serve as many patients as possible. Restrictions on how late in pregnancy the drug can be administered and how — under the ruling, dispensing it by telemedicine is barred — could add additional hurdles and lead to increased wait times.
Sylvia Ghazarian, executive director of Women’s Reproductive Rights Assistance Project, a nonprofit organization that helps people obtain funds for abortions or emergency contraceptives, said that 70 percent of the patients they have helped obtain abortions used medications. Seventy-five percent of the people they serve are people of color.
Ghazarian said that forcing the communities that they serve to go into clinics — instead of the lower-cost and more private option of receiving the drug via mail — will significantly impact access.
“Access has always been an issue for marginalized communities because a clinic is not necessarily in a location that is easily accessible,” Ghazarian said. “Many have to travel 60 miles or more to get to a clinic, which adds to the domino effect of taking time off work, child care issues and all of the practical support-type challenges that an individual may also be facing.”
It is unclear how this decision will impact clinics’ process for administering medication abortions. Medication abortions can still be carried out only using misoprostol, the drug typically used in tandem with mifepristone. However, the one-pill regimen is less effective than the combination of drugs.
Kimberly Inez McGuire, the executive director of Unite for Reproductive and Gender Equity, a reproductive rights advocacy group, called the Texas ruling a “stunning overreach.”
“The fight is not over, and the implications of this latest decision are not yet clear,” McGuire said. “What we do know is that mifepristone remains safe, effective and an essential part of abortion care.”
The Biden administration has been vocal about its desire to keep mifepristone on the U.S. market and as readily available to patients as possible. At a White House Task Force on Reproductive Healthcare Access meeting on Wednesday, ahead of the appeal ruling, Vice President Kamala Harris warned about the potential long-lasting implications of the Texas district court ruling.
“We have in effect a situation where politicians and politics have driven lawyers to go to a court of law where a judge, who is not a medical professional, is making a decision to undo the ruling of over 20 years ago of the FDA, that declared a specific medication safe and effective for the American people,” Harris said. “So one must appreciate that when we think about the integrity of our health care delivery systems. Attacking the very credibility of the FDA on this one matter for the sake of politics and a political agenda can have wide, sweeping ramifications.”
Attorney General Merrick Garland said at the same meeting that the Justice Department “strongly disagrees” with the Texas court’s unprecedented decision.
“The Justice Department will continue to defend the FDA approval of mifepristone, as well as the FDA’s role as the expert body that Congress has designated to make decisions about the safety and efficacy of prescription medicines in this country.”
Grace Panetta contributed to this report.