March 28, 2024

The FDA Goes Before SCOTUS

While the headlines focus on the abortion pill, the deeper issue is concern over the politicization of the FDA.

While the question of access to abortion via the drug mifepristone is the headline-grabbing issue before the U.S. Supreme Court, the bigger issue may be the status of the Food and Drug Administration.

In today’s hyper-polarized era, a dead giveaway that a problem is not merely transitory but rather endemic is when it corrupts those federal agencies that are supposed to be non-political.

In this instance, the agency in question is the FDA, which Americans rely on to provide sound and scientifically tested guidelines and regulations for the safe handling of food and drugs. Broad societal trust in the FDA can only be maintained if there is a very clear, consistent, and transparent system of evaluating the things we put on and into our bodies.

While much of the media has focused on the case before the Supreme Court as yet another abortion rights issue, that actually is a narrative intended by leftists to politicize the court.

A survey of mainstream media headlines underscores this. Headlines such as this from Reuters: “US Supreme Court appears skeptical of challenge to abortion pill access.” Or this one from NBC News: “Supreme Court signals it is likely to reject a challenge to abortion pill access.” Time magazine put it this way: “Supreme Court to Decide Fate of Access to Abortion Pill Mifepristone.”

The Wall Street Journal editorial board gets closest to the real issue with an article simply titled, “The Supreme Court and Mifepristone.” The Journal’s teaser adds, “The question in a case about the abortion pill is whether judges can act as a Super FDA on drug approvals.”

Yes, the justices have to decide whether doctors who filed the suit against the FDA have standing. However, even the Journal paints it as if the justices have to decide on the medical merits of procedures for which they have no expertise. But that’s not what the Court is being asked to decide.

The issue is whether the FDA’s changing of the rules for administering mifepristone was done properly and in accordance with its own well-developed and long-standing standards. According to the plaintiffs, the FDA’s decision to ease restrictions on administering mifepristone was made in violation of the Administrative Procedure Act (APA). Furthermore, the plaintiffs contend that the FDA’s easing of restrictions will send more women to the emergency room.

The Fifth Circuit Court of Appeals ruled that the doctors who brought the lawsuit have legal standing based on the possibility that they may have to treat women with complications due to mifepristone.

The question the justices seem to be stuck on is not that of standing but of lane-keeping. In a statement eerily similar to Ketanji Brown Jackson’s infamous “I’m not a biologist” refusal to define what a woman is, Justice Brett Kavanaugh, back when he served on the DC Circuit Court of Appeals, wrote, “Courts must be careful not to unduly second-guess an agency’s scientific judgment.”

But, again, that’s not what the plaintiffs are asking the Court to do. They simply want a ruling on whether the FDA violated the APA when it loosened the administration protocols for mifepristone.

Was the basis for the FDA’s decision to remove the maternal-safety protections for mifepristone motivated by science or politics? If it was politics, it is both troubling and dangerous, and it calls into question the agency’s trustworthiness — which is why the justices’ decision in this case is so significant.

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