Federal Court Rules to Pull Abortion Drug Off Market Nationwide 

04.07.23 (PRESS RELEASE) — Today, a federal court in Texas has ruled to block the Food and Drug Administration (FDA)’s approval of mifepristone—one of the two drugs used in medication abortion. The court’s unprecedented decision will take effect in seven days, giving the FDA time to appeal the ruling before it takes effect. If allowed to take effect, this ruling could gravely limit abortion access across the country, including in states where abortion is protected. Currently, medication abortion accounts for more than half of all abortion care in the U.S. and most of those include mifepristone as part of a two-drug regimen. Without access to the most common method of abortion, patients’ options for care would be drastically reduced, leading to the delay or denial of care. Today’s ruling is in response to a lawsuit filed by anti-abortion groups challenging the FDA’s approval of mifepristone.

Despite mifepristone being used safely in the U.S. and around the world for decades, Judge Matthew Kacsmaryk sided with plaintiffs who falsely claim that the FDA did not sufficiently study the safety and efficacy of the drug or use the proper process to approve it over 20 years ago. The judge attempts to block the approval of mifepristone and remove it from the market nationwide.

“Today’s decision has no basis in law or fact. This lawsuit was manufactured as part of an orchestrated campaign to deny all women in the U.S. access to abortion, even those living in states with strong abortion rights protections,” said Nancy Northup, president and CEO at the Center for Reproductive Rights. “While the decision is without merit, its impact will be devastating, threatening access to a safe and effective medicine used by over five million patients in the past two decades. The ruling should be swiftly reversed on appeal. It’s abundantly clear that those who rely on a fact-based, scientific FDA drug approval process, including major pharmaceutical companies, need to speak out about the travesty of this case.”

Immediately after the ruling, a federal court in Washington issued a conflicting decision, ordering the FDA to keep mifepristone available under the current regulations. The FDA most recently expanded access to medication abortion, allowing patients to access the drug through the mail via telemedicine or from their local pharmacy. The competing orders from two federal judges about a drug that has been approved for 20 years is unprecedented, and it is unclear what the impact will be.  

Mifepristone was approved by the FDA in 2000 and since that time, medication abortion has been used by nearly 5 million patients across the country. Numerous studies have repeatedly shown the safety and efficacy of mifepristone in the two-drug medication abortion regimen. Medication abortion accounts for more than half (54%) of all abortions in the U.S., and 98% of medication abortions in 2020 used the two-drug protocol. Leading medical organizations, including the American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association (AMA) oppose restrictions on mifepristone.

Without the FDA-approved medication, both clinics and patients across the country will struggle to provide and access time-sensitive abortion care. In Maine alone, where the right to abortion is protected under state law, the share of counties with an abortion provider could drop from 88% to as low as 19% if mifepristone is not available. Since Roe v. Wade was overturned, providers across the country have already seen a massive influx of patients and increased wait times, pushing time-sensitive care out of reach for many. The impacts of today’s decision will fall hardest on communities who already face structural barriers in accessing health care, including communities of color, people living in rural areas, and those living on a low income.

The AMA and ACOG have expressed concern over the lack of access to abortion—including medication abortion—on patients’ health. They warn that the maternal mortality rate in the U.S., which is already among the highest in the world, will worsen without access to abortion care, including mifepristone. Pharmacy groups have also said that patients’ health is at risk without the availability of mifepristone, which is also used to treat ectopic pregnancies, miscarriages, and other medical conditions.

The impacts of today’s decision also go beyond medication abortion access. It threatens the FDA’s authority over the drug approval process, which could severely limit the development of new drugs overall and have far-reaching repercussions on patients’ access to FDA-approved medications.

Those seeking abortion care can visit www.ineedana.com to find the nearest abortion provider.

If you are a U.S.-based abortion provider or supporter in need of legal assistance, you can contact the Abortion Defense Network. ADN connects anyone working to provide or help patients access abortion care with attorneys for legal advice, representation, and funds. Visit https://abortiondefensenetwork.org for more information.

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