Supreme Court Will Address “Abortion Distortions” at the FDA

COMMENTARY Life

Supreme Court Will Address “Abortion Distortions” at the FDA

Jan 17, 2024 3 min read
COMMENTARY BY
Thomas Jipping

Senior Legal Fellow, Center for Legal and Judicial Studies

Thomas Jipping is a Senior Legal Fellow for the Edwin Meese III Center for Legal and Judicial Studies.
A bottle of Mifepristone tablets are displayed at an abortion clinic on April 13, 2023 in Rockville, Maryland. Anna Moneymaker / Getty Images

Key Takeaways

The Supreme Court will now decide a case that reveals how abortion has corrupted the administrative state and will hopefully do something about it.

The FDA dropped the remaining safety rules in 2021, allowing women to obtain mifepristone by mail or through mail-order pharmacies. This violated the Comstock Act.

Abortion politics drove the FDA to cut corners, putting the safety of women at greater risk without sufficient evidence.

Abortion poisons everything it touches. Its advocates tell themselves nonsense like the offspring of human beings are not human, or even alive, until they emerge from the womb. Many states that make killing a preborn child without the mother’s consent a crime protect killing a preborn child with the mother’s consent. Courts twist and change established legal principles to accommodate abortion. The Supreme Court will now decide a case that reveals how abortion has corrupted the administrative state and will hopefully do something about it.

Dozens of powerful government agencies issue thousands of rules that dramatically affect our lives. Prescription drugs, for example, cannot be marketed in the United States until the Food and Drug Administration (FDA) deems them “safe and effective” for their intended use. Since the American people do not elect these bureaucrats, however, how can these agencies be held accountable when they ignore the law in making such decisions?

One way, provided by the Food, Drug, and Cosmetic Act, is through filing a “citizen petition” asking the FDA to “issue, amend, or revoke a regulation.” Another is by filing a lawsuit under the Administrative Procedure Act, which requires courts to invalidate agency actions that are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” Pro-life advocates took both of these steps regarding the FDA’s regulation of the abortion drug mifepristone.

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The FDA approved this drug, under the brand name Mifeprex, in 2000 under unusual circumstances. Its many side effects and risks meant it could not be approved through the FDA’s regular evaluation process, but abortion advocates would not be deterred. They pressured the FDA to use a separate fast-track process reserved for drugs that treat “serious or life-threatening illnesses,” effectively equating pregnancy with cancer or HIV. This was the first abortion distortion. The second came when the FDA ignored a citizen petition filed by three-pro-life groups, including two medical associations, challenging the basis for the approval. Federal law required the FDA to respond within 180 days; the FDA ignored the petition for 14 years.

The next abortion distortion came when the FDA finally denied the citizen petition in March 2016 and began dropping the important safety rules that came with its fast-track approval. The FDA, for example, canceled the requirement that most medical complications be reported and allowed non-physicians to prescribe and administer the drug. It did so without any evidence about whether or how dropping multiple safety rules at the same time would affect Mifeprex’s safety and effectiveness in general, or its impact on minor girls in particular.

The next abortion distortion occurred when the FDA then dropped the remaining safety rules in 2021, allowing women to obtain mifepristone by mail or through mail-order pharmacies. This violated the Comstock Act, a federal law prohibiting using the mail to distribute any “article or thing designed, adapted, or intended for producing abortion.” The FDA claimed that the lack of reported medical complications showed that abortion drugs are safe—when it was the FDA itself that no longer required reporting most medical complications!

Since the citizen petition route proved ineffective, four medical associations and four individual doctors turned to the courts to hold the FDA accountable. They filed a lawsuit in November 2022, challenging both the FDA’s 2000 approval of Mifeprex and its 2016 and 2021 decisions dropping the safety precautions. They argued that each of these actions violated the Administrative Procedure Act, which sets standards that agencies must follow in making decisions and issuing rules. The APA prohibits agency actions that are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”

>>> Court Slaps Down FDA Again for Illegally Dropping Abortion Pill Rules

This is the case the Supreme Court has agreed to consider. One issue is whether these plaintiffs had legal “standing” to bring the lawsuit in the first place. Standing requires that the plaintiff suffer a legal injury caused by the defendant that a court can remedy. The U.S. Court of Appeals for the Fifth Circuit said that both the associations and the individual doctors had standing.

The second issue is whether the FDA’s actions were lawful under the APA. The appeals court decided that the lawsuit challenging the original Mifeprex approval was filed too late, and the Supreme Court will not address that issue. It will, however, decide whether the appeals court correctly concluded that the FDA’s decisions to drop the safety rules violated the APA.

Abortion politics drove the FDA to cut corners, putting the safety of women at greater risk without sufficient evidence, and to authorize widespread mail-order distribution of dangerous drugs in violation of federal law. This case is less about the decision the FDA actually made than about whether it followed the law when making it. There can be no abortion exception to the requirement that the government follow the law when making decisions that affect our lives, and the Supreme Court should resoundingly say so.

This piece originally appeared in Christian Renewal