Court says FDA must restore abortion pill safety measures, pending Supreme Court review

The U.S. Court of Appeals for the Fifth Circuit ruled on Wednesday to allow the abortion pill mifepristone to remain “available to the public under the conditions for use that existed in 2016″ while it vacates more recent expansions of the drug’s approved use under the Food and Drug Administration’s (FDA) safety requirements (REMS). Those expansions removed the in-person dispensing of the abortion pill and enabled the drug to be shipped by mail — and also expanded the use of the pill from seven (7) weeks to 10 weeks.

In addition, the Court’s abortion pill ruling will allow the “generic version of mifepristone,” which was approved in 2019, to “be available under the same conditions as Mifeprex.”

However, as Bloomberg states, “The decision… won’t have an immediate impact on access to the medication, mifepristone. The pill remains available under an April order from the US Supreme Court that will stay in effect until the high court rules again on the matter or refuses to hear the case on appeal.”

Calling the decision a “victory for women’s health,” Alliance Defending Freedom (ADF), which represents the plaintiffs in the case, claimed in a press release that the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration found that the FDA must restore critical safeguards for chemical abortion drugs.

“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” ADF  Senior Counsel Erin Hawley, vice president of the ADF Center for Life and Regulatory Practice, wrote of the Court’s ruling.

The decision, rendered by Judges Jennifer Walker Elrod, James Ho, and Cory Wilson, looked at four actions: the 2000 Approval, the 2016 Amendments, the 2019 Generic Approval, and the 2021 Non-Enforcement Decision. Those actions were “challenged by the Alliance for Hippocratic Medicine—an association of doctors who research, teach, and advocate for ethical medical practices—several similar organizations, and several individual doctors,” the document in the Court’s ruling stated.

“At bottom, the Medical Organizations and Doctors contend that FDA overlooked important safety risks in approving mifepristone and amending its restrictions. They assert that FDA’s actions were unlawful under the Administrative Procedure Act,” the decision read in part. “According to the Doctors, when they treat women who are experiencing complications after taking mifepristone, they are required to perform or complete an abortion, or otherwise required to participate in a process that facilitates abortion. They maintain that personally conducting those procedures violates their sincerely held moral beliefs. The Doctors also contend that treatment of mifepristone patients diverts time and resources away from their ordinary patients, causes substantial mental and emotional distress, and exposes them to heightened malpractice risk and increased insurance costs.”

1st Trimester Abortion | The Abortion Pill | What Is Abortion?

“Seeking to prevent those alleged injuries, the Medical Organizations and Doctors moved for preliminary injunctive relief. The district court granted the motion, but rather than entering a traditional injunction, the court stayed the effective date of each of the challenged actions under 5 U.S.C. § 705. FDA appealed, as did Intervenor Danco Laboratories, LLC, the pharmaceutical company that distributes Mifeprex,” the ruling stated.

Then, in rendering their decision in the abortion pill ruling, the three-judge panel wrote:

After extensive briefing and oral argument, we hold that the district court’s stay order should be VACATED in part and AFFIRMED in part. We conclude that the Medical Organizations and Doctors’ claim as to the 2000 Approval is likely barred by the statute of limitations. Accordingly, that component of the district court’s order must be VACATED. This means that, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016.

We also VACATE the portion of the order relating to the 2019 Generic Approval because the Medical Organizations and Doctors have not shown that they are injured by that particular action. The generic version of mifepristone will also be available under the same conditions as Mifeprex.

We AFFIRM the components of the stay order that concern the 2016 Amendments and the 2021 Non-Enforcement Decision.

Those agency actions—which generally loosen the protections and regulations relating to the use of mifepristone—will be stayed during the pendency of this litigation.

Finally, we note that our holding is subject to the prior order of the Supreme Court, which stayed the district court’s order pending resolution of this appeal and disposition of any petition for writ of certiorari. Danco Lab’ys, LLC v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023) (mem.).

In a press conference after the decision was released, ADF representatives said they would be reviewing the ruling with regard to the Court panel’s findings that their request to nullify the FDA’s 2000 approval of the abortion drug exceeded the statute of limitations, before deciding whether to file an appeal.

Backstory

The abortion pill mifepristone was approved by the Food and Drug Administration (FDA) in 2000, for use up to 7 weeks of pregnancy in a regimen along with the drug misoprostol. But by 2011, the FDA made the decision to place the drug under its REMS safety system, but not before multiple women had died in association with the use of the abortion pill regimen.

Just five years later, in 2016, the Obama Administration FDA weakened the REMS by removing the requirements that women or teen girls take the first drug in front of a clinician, in person at the location of a certified prescriber and that the manufacturer report the drug’s non-fatal adverse events (complications).

Therefore, since 2016, adverse events or complications of the drug are no longer required to be reported — just deaths.

The TROUBLING History of the ABORTION PILL

In April of 2021, under the guise of the COVID-19 pandemic, the FDA temporarily enabled abortion pill distribution and expanded the REMS to allow limited mail-order pharmacy distribution. By December 2021, the Biden FDA further weakened the REMS by eliminating the in-person dispensing requirement and enabling the abortion pill to be permanently shipped by mail. Then, in January 2023, the Biden FDA further gutted the REMS by announcing it would allow retail pharmacies to dispense the abortion pill.

In November, Alliance Defending Freedom filed a federal lawsuit on behalf of the Alliance for Hippocratic Medicine, challenging FDA approval of mifepristone. The move followed the FDA’s unsatisfactory responses to a number of citizen petitions the group had submitted. That same year, GenBioPro (GBP) voluntarily dismissed a lawsuit challenging pro-life legislation in Mississippi. The AHM lawsuit centered on a ruling by U.S. District Court Judge Matthew J. Kacsmaryk which suspended the FDA’s 2000 approval of the abortion pill mifepristone, and all decisions made thereafter. The case was then appealed, but a temporary stay was issued by the Supreme Court until a decision could be rendered by the U.S. Court of Appeals for the 5th Circuit, which was heard before a panel of judges in June of this year.

The expansion of the abortion pill followed clinical trials and published studies authored by some with close ties to abortion pill manufacturers and investors. Live Action News’ “Bad Actors” series details how the abortion industry has repeatedly flouted FDA’s REMS by prescribing the drug past the approved gestational limit as well as to women who are not even pregnant, leaving women to deal with potentially dangerous ectopic pregnancies on their own, and encouraging emergency staff to conceal complications.

“The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen. 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,” ADF stated.

According to Bloomberg.com, the abortion pill ruling will not take effect “until the high court rules again on the matter or refuses to hear the case on appeal.”