Abortion Pills, the FDA and the Courts

In the aftermath of the Dobbs decision, litigation continues mostly in the States about what protections should exist for unborn babies. Within the past week, however, the federal courts have issued rulings about whether the abortion pill should remain FDA approved (and thus widely available for purchase). A District Court in Texas issued a ruling blocking the FDA approval of the drug by placing a Stay on it. The drug at the center of this case was approved in 2000 by the FDA; The Plaintiffs, a group of medical professionals, are contesting that approval.

Readers can justifiably ask why is this case just being heard now after 2 decades of usage. The first page of the opinion answers clearly that question; the FDA had delayed judicial review dating back to 2002 by ignoring the issues that Plaintiffs raised back then. With that threshold question about why now being answered, the opinion delves into the issues that Plaintiffs raised with the original FDA approval in 2000 and subsequent loosening of standards that the FDA allowed since then. With every federal case, Plaintiffs must show standing. The judge recognized that Plaintiffs have standing because they treat women who have been harmed by these drugs. Page 10 of the ruling recognizes “Plaintiff physicians often spend several hours treating post-abortive women, even hospitalizing them overnight or providing treatment throughout several visits.”

Plaintiffs pointed to several issues after the drug was approved under accelerated approval. Under accelerated approval (Subpart H), drugs must be used to treat a serious illness or a life threatening diseases AND a meaningful benefit is available over existing treatments. In 2000, to ensure safe usage, the FDA limited the drug to below 7 weeks of pregnancy, required 3 office visits and mandated doctors report ALL adverse effects from the usage.

The House of Representatives held a hearing in 2006 noting several of the harms that had occurred to women who had taken these drugs and noted that several women had died and the staff report that was issued after the hearing noted that the FDA approval was substandard and the drug should be withdrawn from the market so more women don’t suffer adverse events.

The FDA finally rejected the complaints the Plaintiffs made in 2002 in 2016; when a government agency takes an action, they only have 180 days, not 14 years to respond to comments. That same day in 2016, the FDA loosened safety restrictions by allowing the pill to be used up to 10 weeks, reduced the number of in person visits from 3 to 1 and allowed non-doctors to prescribe the drug and changed the requirement that doctors report ALL adverse effects to report only deaths. In 2019, Plaintiff filed a second petition due to the elimination of the major safeguards. After the lawsuit began, the FDA eliminated the in person dispensing requirement, so the drug could be shipped by mail. Plaintiff raised the issue of the Comstock Act, which prohibits the mailing of materials to cause an abortion.

The Judge ruled that the FDA’s 2000 approval violated Subpart H because pregnancy is NOT a serious illness or a life threating illness. Page 40 of the opinion reads “Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life. Defendants even admit pregnancy is not an ‘illness.’… complications or negative psychological experiences arising from pregnancy as “illnesses” is materially different than classifying pregnancy itself as a serious or life-threatening illness per se.” The Judge continued on page 44 that “Similarly, chemical abortion drugs cannot be “therapeutic” because the word relates to the treatment or curing of disease.” The Judge also noted on page 46 that before the FDA approval was granted, the FDA recognized the “medical regimen had more adverse events, particularly bleeding, than did surgical abortion. Failure rates exceeded those for surgical abortion”.

For those reasons, the Texas District Court stayed the approval of the drugs at 2000 and everything that followed from that approval until it goes up on appeal. Because this ruling deals with the FDA approval and the FDA approval applies in every State, this ruling has an application in every State.

A District Court in Washington State forbid the FDA from altering the status quo as it existed in January 2023, but this ruling is limited to the Plaintiff States only and does not cover every State in the nation.

More recently, the 5th Circuit of Appeals issued a ruling filed on April 12, upholding parts of the Texas District Court’s Order. The 5th Circuit conducted a limited review of the record and ruled that the statute of limitations, which is 6 years, may bar a challenge of the original approval in 2000, but the challenge to the 2016 revision of the rules surrounding the dispensing of this drug is timely because the lawsuit started in November 2022.

This means the regulations that were in place in 2016 are the same one that will be in place if the ruling doesn’t get disturbed by the Supreme Court. The oral arguments over the merits will be expedited, but this stay is merely a procedural one. Because the Justice Department did not get a stay pending appeal, but only a procedural stay, the DOJ has appealed to SCOTUS, as the DOJ wants loose restrictions on this medication.

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