What to watch for at Wednesday's hearing in medication abortion lawsuit

[mahatmakanejeeves]

1. Actually, One Texas Judge Is Not the Final Decision-Maker on Medication Abortion

JURISPRUDENCE

Actually, One Texas Judge Is Not the Final Decision-Maker on Medication Abortion

One district judge’s ruling does not have to affect the entire country.

BY DAVID S. COHEN, GREER DONLEY, AND RACHEL REBOUCHE
FEB 28, 20232:11 PM

All eyes in the fight over reproductive rights and justice have been focused on a federal judge in Amarillo, Texas. District Judge Matthew Kacsmaryk will soon decide a case involving the first drug in a medication abortion, mifepristone. Though the case makes wholly unpersuasive arguments, undermined by the facts and the evidence, plaintiffs filed in this specific court because Kacsmaryk is one of the most conservative judges on the federal bench and has an explicit and documented animus toward abortion. The expectation is that he will do everything in his power to end medication abortion as we know it. Because states like Texas have already banned abortion (including medication abortion), the deep fear is that his ruling could affect abortion care even in states where it remains legal.

But we would like to offer some clarification here. Because despite the barrage of predictions that this case could ban mifepristone and take it off the market, there are several basic legal principles suggesting that Judge Kacsmaryk’s power is limited and that a ruling for the plaintiffs will not necessarily change much at all with medication abortion.

Some background first. Medication abortion typically occurs, in this country, with two different drugs—mifepristone followed by misoprostol. From the most recent data, abortion pills account for roughly 53 percent of abortions in this country, and given that this data is a few years old now, it’s probably much higher. Many people prefer medication abortion for a variety of reasons: It allows people to have an abortion in the privacy of their homes and it is available by telehealth, which is usually cheaper than an abortion at a brick-and-mortar clinic.

Because of the increasing importance of medication abortion in the face of all of the restrictions and bans following the Dobbs decision, an anti-abortion group filed this lawsuit challenging the Food and Drug Administration’s 23-year-old approval of mifepristone. Essentially, the plaintiffs argue that the FDA acted improperly when it approved this drug in 2000. The case also challenges several subsequent reviews the FDA conducted of the drug, claiming that the agency ignored the evidence that mifepristone was too risky. As a result, the lawsuit asks the court to deem the FDA’s approval of the drug unlawful.

To be clear, mifepristone is one of the most studied drugs in this country. The evidence shows that it is safer than penicillin, Viagra, and thousands of other drugs the FDA has approved. There is no evidence that the FDA acted improperly in approving mifepristone; FDA law scholars and government agencies, like the Government Accountability Office, agree. (If you want to read more about abortion pills, we have a forthcoming law review article available here that explains all you need to know.) So the medical basis for this argument is meritless.

But even if Judge Kacsmaryk does exactly what the plaintiffs are asking of him, regardless of the faulty science, his legal power in this case is limited. First, as an amicus brief from FDA law scholars (including one of the authors of this piece) makes clear, Congress crafted procedures by statute for the FDA to use to withdraw approval of a drug. Judge Kacsmaryk cannot force the FDA to adopt another process to do the same—doing so would violate federal law. At best, he should only be able to order the agency to start the congressionally mandated process, which involves public hearings and new agency deliberations. This could take months or years, with no guarantee of the result.

{snip}