The long-used abortion pill in the US is threatened in a lawsuit in Texas

(David Erickson/Associated Press)

The long-used abortion pill in the US is threatened in a lawsuit in Texas

SEAN MURPHY and MATTHEW PERRONE

March 15, 2023

A conservative Texas judge on Wednesday questioned a Christian group’s attempt to overturn the decades-old approval of a leading abortion drug by federal regulators in a case that could threaten the U.S.

most common method of terminating pregnancies.

Judge Matthew Kacsmaryk

Heard over four hours of debate on the Alliance Defending Freedom’s request to repeal or suspend the Food and Drug Administration

approval of mifepristone

. Such a move would present an unprecedented challenge to the FDA and its authority in deciding which drugs to allow on the market. Kacsmaryk said he would rule as soon as possible without giving any clear indication of how he might decide and leaving open the question of whether access to the standard drug abortion regimen could soon be restricted across the country.

Mifepristone, in combination with a second pill,

was approved in 2000 and is used to terminate pregnancies up to their 10th week. It has been prescribed more and more since last summers

U.S. Supreme Court ruling declaring Roe v. Wade is destroyed

. The Texas lawsuit has become the latest high-stakes legal battle over access to abortion since the question of its legality was returned to the states.

Kacsmaryk, who was appointed by

Than-

president trump,

reserved some of his most pointed questions for lawyers representing the alliance, which filed the case in Amarillo pending a favorable ruling. Explain to me why this court has such far-reaching authority? asked Kacsmaryk, referring to the group’s request that mifepristone be withdrawn from the market. The judge also questioned whether the group had the legal standing to obtain a preliminary ruling, challenging both sides in US Supreme Court cases outlining when such extraordinary assistance is allowed. Yet the judge also raised questions suggesting he was considering how to draft a preliminary injunction in favor of the plaintiff, at one point asking alliance lawyers whether the issue of status had been clearly addressed by the appellate courts . At another point he told them that their scheme for the order of their arguments follows the elements of an order nicely.

Attorneys for the FDA

are expected to

argued that pulling mifepristone would disrupt reproductive care for American women and undermine government scientific oversight of prescription drugs.

Justice Department attorney Julie Harris said the injunction requested by the conservative group would disrupt the status quo by banning a drug that has been on the market for more than two decades. One of the main arguments against the FDA in the lawsuit is that the agency

abused its authority when it originally approved the abortion pill.

The FDA evaluated the drug under its so-called accelerated approval program, which was created in the early 1990s to accelerate access to the first HIV drugs. Since then it has been used to accelerate drugs for cancer and other serious or life-threatening diseases.

The plain text is clear that it applies to diseases, argued Erik Baptist, the alliance’s lead attorney. Mifepristone is used to terminate pregnancies and pregnancy is not a disease. The FDA rejected the group’s argument on multiple accounts. First of all lawyers

the FDA regulations make it clear that pregnancy is considered a medical condition that can be serious and life-threatening in some cases.

second,

government lawyers said the terms of mifepristones’ approval were superseded more than a decade ago by subsequent FDA programs passed by Congress, rendering the argument irrelevant. Legal experts have long been highly skeptical of many of the arguments advanced in the alliance lawsuit. And there is essentially no precedent for a lone judge overruling the FDA’s scientific judgments. At one point, Kacsmaryk asked the alliance’s lawyers about the possibility of suspending the approval of mifepristone, without withdrawing it completely. Any exemption you grant must be complete and applicable nationwide, Baptist replied. The harm of these abortion drugs knows no bounds.

Kacsmaryk gave each side two hours to present their arguments, with time for refutation in the highest-stakes case. Manufacturer of mifepristones, Danco Laboratories,

joined

the FDA in the argument to keep the pill available.

A verdict could come at any time

after the arguments are over

. A decision against the drug would soon be appealed by attorneys from the US Department of Justice representing the FDA, and likely

probably

find an emergency stay to prevent it from taking effect while the case continues.

Members of the advocacy group Women’s March gathered outside the courthouse, including one dressed as a kangaroo, to denounce the proceedings as a kangaroo court.

Ultimately, courthouse officials allowed 20 members of the media and 20 members of the general public to attend the hearing. Most of the pews were full, though the two rows of seats for courthouse staff and lawyers were not.

If Kacsmaryk speaks out against the FDA, it’s unclear how quickly access to mifepristone could be restricted or how the process would work. The FDA has its own procedures for withdrawing drug approvals that include public hearings and scientific deliberations, which can take months or years.

If mifepristone is sidelined, clinics and doctors who prescribe the combination say they would switch to using misoprostol alone, the other drug used in the two-drug combination. That single-drug approach has slightly lower effectiveness in terminating pregnancies, but is widely used in countries where mifepristone is illegal or unavailable.

In addition to challenging mifepristone’s approval process, the lawsuit focuses on several subsequent FDA decisions that relaxed restrictions on the pill, including removing the requirement for women to pick it up in person.

FDA advocates have pointed out 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 stated in its legal response.

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