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Fifth Circuit Rules Chemical Abortion Drug Safeguards Must Be Restored by FDA

Girl taking white pill and holding glass of water

According to a report from our allies at Alliance Defending Freedom (ADF), “In a victory for women’s health, a unanimous panel for the U.S. Court of Appeals for the Fifth Circuit ruled Wednesday [8/16] that the Food and Drug Administration must restore critical safeguards for chemical abortion drugs and disallow their shipment by mail.” ADF is representing four medical associations and four doctors that brought this case challenging the use of these abortion drugs.

ADF stated: “The FDA’s unprecedented and unlawful actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health or the rule of law. This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.”

When the FDA originally approved the chemical abortion drug Mifepristone in the year 2000, a number of important safeguards were put into place, including:

  • A limit only allowing the drug to be administered up to 7-weeks gestational age of the unborn child;
  • Necessary doctor’s office visits;
  • In-person physician dispensing and administration of the medication; and
  • Non-fatal adverse event reporting.

In 2016, the FDA loosened some restrictions, allowing:

  • Prescriptions of the chemical to be made via telehealth;
  • Non-physician providers to place orders for the drug;
  • Prescriptions up to 10-weeks gestational of the unborn child;
  • Elimination of the reporting of non-fatal events.

In 2021, the FDA further allowed Mifepristone to be shipped to patients through the mail.

If the Fifth Circuit’s opinion ultimately prevails, it would restore the regulatory framework back to what it was before the 2016 amendments.

In North Carolina

This decision by the 5th Circuit has implications for the country, but it also reinforces North Carolina’s law which requires women to see a physician in person, and to take the Mifepristone in the doctor’s presence. This is a crucial safeguard because doctors should verify the pregnancy and the gestational age of the baby, rule out ectopic pregnancies, and witness the patient begin the drug regimen, ultimately making this a safer experience for women and girls across our state and nation.

More Broadly

Unfortunately, the 5th Circuit did not agree with the lower court ruling that would have removed Mifepristone completely from use. The Court found that the statute of limitations would likely not allow them to consider a challenge to the original FDA approval of the drug that occurred in the year 2000.

The ruling concluded that: “In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.

At this preliminary stage, the Medical Organizations and Doctors have made a substantial showing that the 2016 Amendments and the 2021 Non-Enforcement Decision violate the APA. Accordingly, those actions will be stayed pending final judgment. But to repeat, all of this relief is subject to the Supreme Court’s prior order, which stays the district court’s order until the disposition of any petition for certiorari.”


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