Texas court files lawsuit over abortion pills

AMARILLO, Texas. On Wednesday, a federal judge will hear arguments in a high-stakes court case that could jeopardize access to medical abortion and weaken the credibility of US drug regulators.

Judge Matthew Kachsmarik of Texas is considering a lawsuit from Christian conservatives seeking to overturn a Food and Drug Administration decision more than 20 years ago approved by the Food and Drug Administration regarding the abortion pill mifepristone. The drug, when used with the second pill, became the most common abortion method in the US.

In fact, there is no precedent for a lone judge overturning FDA scientific decisions. And legal experts are warning of far-reaching consequences if judges start reviewing FDA decisions on drug safety and efficacy.

Wednesday’s hearing is the first in the case that is being actively followed by groups on both sides of the abortion issue since last year’s retrial of Roe v. Wade. However, there was little advance notice of the high-profile meeting, which went public online late Monday evening after news reports raised concerns about a lack of transparency in the proceedings.

On Friday, Kaczmarik told lawyers in the case that he would delay filing the application to minimize threats and potential protests, first reported by The Washington Post. He also asked lawyers not to disclose the date of the meeting, according to the transcript of the meeting, released on Tuesday.

Such action by a judge is highly unusual because court proceedings are almost always open to the public, and transparency is a core principle of the American judiciary.

Kaczmarik, who was appointed by President Donald Trump, previously worked as an attorney for a Christian legal group and wrote critical articles about laws that allow abortion. Abortion rights advocates say conservatives are taking cases to his courtroom because they think he will rule in their favor.

On Wednesday, Kaczmarik will hear arguments in Amarillo from the Freedom Defense Alliance, which filed the lawsuit on behalf of several anti-abortion groups and doctors, as well as federal prosecutors representing the FDA. The manufacturer of the drug, Danco Laboratories, is also a party to the case and is going to advocate for its tablets to be available.

The alliance is seeking an injunction that would force the FDA to withdraw its approval of mifepristone. But it is not clear how quickly this can happen and what this process will entail. The FDA has its own drug revocation procedures, which include public hearings and scientific deliberations that can take months or years.

If Kaczmarik rules against the FDA, federal prosecutors are expected to quickly appeal the decision and seek an emergency delay so that it does not go into effect while the case continues.

Mifepristone is part of a two-component regimen that has been the standard for medical abortion in the US since 2000. If mifepristone is removed, clinics and doctors prescribing the combination say they plan to switch to only the second drug, misoprostol. This single drug approach is slightly less effective in terminating a pregnancy, although it is widely used in countries where mifepristone is banned or not available.

The Texas lawsuit alleges that the FDA’s approval of mifepristone in 2000 was flawed for several reasons, including inadequate analysis of the pill’s safety risks. The lawsuit also challenges several more recent FDA decisions that loosened restrictions on the pills, including removing the requirement for women to pick them up in person.

FDA lawyers have indicated that serious side effects of mifepristone are rare, and the agency has repeatedly confirmed the drug’s safety by reviewing subsequent studies and data. Withdrawing the drug more than 20 years after approval would be “extraordinary and unprecedented,” the government said in its legal response.

As a rule, the FDA’s power to regulate prescription drugs has gone unpunished. But more than a dozen states now have laws restricting abortion in general – and the pill in particular – after last year’s Supreme Court ruling overturning Roe v. Wade.

Lawsuits challenging state restrictions, including in North Carolina and West Virginia, are being considered separately and are expected to continue for many years.

This was reported by Perrone from Washington.