Dueling Abortion Pill Rulings Invalidate FDA Approval

Dueling Abortion Pill Rulings Invalidate FDA Approval

Charley Levine, Staff Writer

On Friday, April 7, Texas judge Matthew Kacsmaryk’s preliminary ruling, which sought to undermine the FDA’s judgment rendered over two decades ago, launched contentious disputes across the nation over the indefinite fate of women’s access to adequate abortion medications.

In this court case, Alliance for Hippocratic Medicine v. U.S Food and Drug Administration, an anti-abortion alliance, according to The Washington Post, alleged that the FDA’s authorization of mifepristone was not only endangering to women but that the conclusion itself was anti-science. The Alliance, incorporated in Amarillo, had been developing a plethora of faulty evidence for some time, and once finalized, the group is believed to have cherry-picked Kacsmaryk’s court, one of the more conservative ones likely to rule in its favor.

In the ruling this past week, the plaintiffs sued to invalidate the U.S Food and Drug Administration’s approval of mifepristone, a synthetic steroid capable of inhibiting the hormone progesterone, required for maintaining a pregnancy. For decades, more than half of women seeking abortions in the US have undergone medication abortions, most of which employ mifepristone along with misoprostol to terminate a pregnancy. Nevertheless, U.S. district judge Matthew Kacsmaryk of Texas voted to revoke the administration’s longstanding approval of the drug. This weighty stance to upend such a deep-rooted authorization, of course, has come with some major implications, many of which are still to be determined. Primarily, though, if the case were to stand, women across America, even in states where abortion is legal, would be deprived of the medication.

The ruling, though, would not go into effect for seven days, allowing time for the FDA to respond, and if desired, appeal. And indeed, Kacsmaryk’s stance prompted a 49-page appeal on behalf of the Justice Department. This appeal, which very swiftly followed Friday’s ruling, challenged the credibility and legal grounds of antiabortion groups. Hundreds of pharmaceutical executives also spoke out against the implausible claims, publicly announcing that the ruling neglects decades of legal precedent and scientific conclusions.

Fortunately, according to The New York Times, an appellate ruling in New Orleans convened the following evening on Thursday to take immediate action after being called upon by the Justice Department. The divided three-judge panel concluded that mifepristone should remain accessible to women as the lawsuit against the FDA proceeds through the courts. Within the next few days, however, it is likely that the Biden administration’s emergency application will be decided upon and that the case will then proceed to the justices for a ruling on the merits.

Whatever the result, the rulings have ultimately left the FDA in a precarious position; these unprecedented circumstances that have undercut the FDA’s decision will unquestionably lead to greater public distrust of the FDA’s judgment going forward. President Biden, as well, has voiced his long-term concerns. “If this ruling were to stand, then there will be virtually no prescription approved by the FDA that would be safe from these kinds of political, ideological attacks,” he said in a statement the night of Judge Kacsmaryk’s decision.

Even if mifepristone were to be kept accessible, it is believed that the restrictions would tighten. With still various steps to go, women anxiously await the results of a ruling that may once again strip them of their basic freedoms and of their agency in deciding what to do with their own bodies.