World News | Long-used abortion pill in US under threat in Texas lawsuit

AMARILO, March 16 (AP) — A conservative judge in Texas on Wednesday challenged a Christian group’s attempt to overturn decades-old federal regulators’ approval of a major abortion drug in a case that could threaten the country’s most commonly used method of terminating pregnancy.

Judge Matthew Kacsmaryk argued for more than four hours on ADF’s request to revoke or suspend the FDA’s approval of mifepristone. The step would pose an unprecedented challenge to the FDA and its authority to decide which drugs to allow on the market.

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Kacsmaryk said he would make a ruling “as soon as possible,” but did not spell out how he would decide or whether the standard regimen of medical abortion would be reduced soon across the country.

Used in combination with another pill, mifepristone was approved in 2000 to terminate pregnancies up to the 10th week. Since the U.S. Supreme Court overturned the Roe v. Wade decision last summer, more and more people have started using it.

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

Kacsmaryk, who was appointed by former President Donald Trump, left some of his toughest questions to attorneys representing the coalition, which filed the lawsuit in Amarillo in anticipation of a favorable ruling.

“Explain to me why this court has such broad powers?” Kacsmaryk asked, referencing the group’s request to remove mifepristone from the market.

The judge also questioned whether the group had the legal standing to obtain a pretrial decision to hear both sides in a case under U.S. Supreme Court rules on when such extraordinary relief is permitted.

Still, the judge asked questions that suggested he was considering how to draft a preliminary injunction favoring the plaintiffs, at one point asking the league’s lawyers whether the appeals court had explicitly addressed the standing issue. At another point, he told them that their outline of the sequence of arguments “traces well the elements of the prohibition”.

Lawyers representing the FDA argued that removing mifepristone would disrupt reproductive health care for American women and undermine the government’s scientific oversight of prescription drugs. Justice Department prosecutor Julie Harris said the injunction sought by the conservative group would “upend 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 power in initially approving the abortion pill.

The FDA reviewed the drug under its so-called accelerated approval program, created in the early 1990s to speed up access to the first HIV drugs. Since then, it has been used to speed up medicines for cancer and other “serious or life-threatening diseases.”

“The text is clear that it applies to disease,” argued Erik Baptist, the coalition’s lead attorney. “Mifepristone is used to terminate pregnancy, and pregnancy is not a disease.”

The FDA rejected the group’s arguments about multiple accounts. First, the lawyers say, FDA regulations make clear that pregnancy is considered a “medical condition” that can be serious and life-threatening in some cases.

Second, government prosecutors say the terms of mifepristone’s approval were superseded more than a decade ago by an FDA program subsequently passed by Congress, rendering the debate irrelevant.

Legal experts have long been deeply skeptical of many of the arguments made in the league’s lawsuit.And there is virtually no precedent for a single judge to overturn an FDA scientific judgment

At one point, Kacsmaryk asked the league’s surrogates about the possibility of suspending mifepristone’s approval, rather than withdrawing it entirely.

“Any relief you grant has to be complete” and applied nationwide, Baptist responded. “The dangers of these abortion pills are limitless.”

Kacsmaryk gave each side two hours to present their arguments — and time to rebut them — in the high-stakes case. Danco Laboratories, maker of mifepristone, joined the FDA in advocating to keep the pills available.

A verdict could come at any time. U.S. Justice Department lawyers representing the FDA will quickly appeal the decision against the drug, and they may also seek an emergency stay to prevent the drug from taking effect while the case is ongoing.

Members of the Women’s March advocacy group rallied outside the courthouse, with one dressed as a kangaroo denouncing the proceedings as “kangaroo court”.

Ultimately, court officials allowed 20 members of the media and 20 members of the general public to attend the hearing. Most of the benches were filled, but the two rows designated for court staff and lawyers were not.

If Kacsmaryk rules against the FDA, it’s unclear how quickly mifepristone use would be restricted, or how the process would work. The FDA has its own process for revoking drug approvals, involving public hearings and scientific deliberations, which can take months or years.

If mifepristone is discontinued, clinics and doctors who prescribe the combination say they will switch to just misoprostol, the other drug used in the two-drug combination. This single-drug approach is slightly less effective in terminating pregnancies but is widely used in countries where mifepristone is illegal or unavailable.

In addition to challenging the approval process for mifepristone, the lawsuit also targets several subsequent FDA decisions to relax restrictions on the pill, including removing the requirement for women to take it in person. (Associated Press)

(This is an unedited and auto-generated story from a Syndicated News feed, the content body may not have been modified or edited by LatestLY staff)