Abortion Pill Challenge Goes Before Texas Judge – The Mercury News

By SEAN MURPHY and MATTHEW PERRONE (Associated Press)

AMARILLO, Texas (AP) – A federal judge will hear arguments Wednesday in a high-stakes court case that could threaten access to medical abortion and undermine the authority of US drug regulators.

Judge Matthew Kacsmaryk of Texas is considering a lawsuit by Christian conservatives aimed at overturning the Food and Drug Administration’s more than two-decade approval of the abortion pill mifepristone. The drug, when used with a second pill, has become the most common method of abortion in the United States.

There is essentially no precedent for a lone judge overturning the FDA’s scientific decisions. And legal experts have warned of far-reaching consequences if judges begin to question FDA decisions about drug safety and efficacy.

Wednesday’s hearing is the first in the case, which is being closely watched by groups on both sides of the abortion issue following the reversal of Roe v. Wade last year. However, there was little advance notice of the high-level session, which only appeared on the online public agenda on Monday after news reports raised concerns about a lack of transparency in the proceedings.

Kacsmaryk told lawyers on the case on Friday that he would delay proceedings to minimize threats and potential protests, a development first reported by The Washington Post. He also asked the lawyers not to disclose the date of the hearing, according to a transcript of the meeting released on Tuesday.

Such actions by a judge are highly unusual because court proceedings are almost always open to the public and transparency is an underlying assumption of the American judicial system.

Kacsmaryk, an appointee of President Donald Trump, previously worked as an attorney for a Christian legal group and has written critically about laws allowing abortion. Abortion rights advocates say conservatives are referring cases to their court because they believe it will rule in their favor.

On Wednesday, Kacsmaryk will hear arguments in Amarillo from the Alliance for Defending Freedom — which filed the lawsuit on behalf of several anti-abortion groups and physicians — as well as federal prosecutors representing the FDA. The drug’s manufacturer, Danco Laboratories, is also a party to the case and must argue to keep its pill available.

The Alliance is seeking an injunction that would force the FDA to revoke the approval of mifepristone. But it’s unclear how quickly that could happen or what the process would entail. The FDA has its own procedures for revoking drug approvals that involve public hearings and scientific deliberation, which can take months or years.

If Kacsmaryk rules against the FDA, federal attorneys are expected to quickly appeal the decision and ask for an emergency stay to prevent it from taking effect while the case proceeds.

Mifepristone is part of a two-drug regimen that has been the standard for medical abortion in the US since 2000. If mifepristone is dropped, clinics and doctors who prescribe the combination say they plan to switch to using just the second drug, the misoprostol. This single-drug approach is somewhat less effective in terminating a pregnancy, although it is widely used in countries where mifepristone is illegal or unavailable.

The Texas lawsuit alleges that the FDA’s 2000 approval of mifepristone was flawed for a number of reasons, including an inadequate review of the pill’s safety risks. The suit also challenges several subsequent FDA decisions that loosened restrictions on the Pill, including the removal of a requirement that women take the Pill in person.

FDA lawyers have pointed out that serious side effects with mifepristone are rare, and the agency has repeatedly affirmed 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.

Typically, the FDA’s authority to regulate prescription drugs remains unchallenged. But more than a dozen states now have laws that broadly restrict abortion — and the pill specifically — following last year’s Supreme Court ruling overturning Roe v. Wade.

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

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Perrone reported from Washington.

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The Associated Press Department of Health and Science is supported by the Educational and Science Media Group at the Howard Hughes Medical Institute. AP is solely responsible for all content.

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