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Abortion Pill Challenge Heads Before Texas Federal Judge

WASHINGTON – A federal judge in Texas will hear arguments Wednesday A closer look at the conflict That could cut off distribution of a key drug used for medical abortions and disrupt access nationwide, even in states where reproductive rights are protected.

Case before US District Judge Matthew Kasmaric The bill was brought in November by a conservative legal group on behalf of anti-abortion medical associations and targets the Food and Drug Administration’s (FDA) approval of the decades-old drug mifepristone, one of two drugs used to terminate early pregnancy.

The associations have urged Kaczmaric to order the FDA to revoke mifepristone’s 2000 approval, arguing the agency erred when it green-lighted the drug under a rule that allows for expedited approval of the drug “for serious or life-threatening illnesses.”

But the Biden administration has warned that such a move would harm patients who rely on abortion pills and further strain state health care systems, especially in areas with clinics already overcrowded as a result of abortion restrictions in neighboring states.

The parties will have two hours to present their arguments before Kaczmaric, and the judge set out a number of issues for them to discuss on Wednesday, including whether the associations have legal standing to sue, whether the ban would serve the public interest and the regulations under which mifepristone was approved.

The jury can issue its decision on the association’s request for a preliminary injunction at any time after the hearing, although an expedited appeal to the US Circuit Court of Appeals for the 5th Circuit is expected.

The challenge to the FDA’s 22-year-old approval of mifepristone has drawn a lot of interest, especially as it comes within the legal landscape in June from the Supreme Court. The decision to overturn Roe v. Wade.

After the Supreme Court ended the constitutional right to abortion, more than a dozen states have imposed almost complete bans on abortion, and 14 have limits on medication abortions. But the lawsuit challenging mifepristone’s approval is the latest attempt to further limit access to abortion.

Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Alabama on March 16, 2022.

Boxes of the drug mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Alabama on March 16, 2022.

Allen G. Breed/AP

In court filings, anti-abortion rights groups claim the FDA overstepped its regulatory authority to approve mifepristone and removed years of protections by changing the dosage and route of administration in 2016 and requiring in-person dispensing. Allow pills to ship in 2021.

“The FDA took these actions by roughshod over the laws and regulations that govern the agency and, more importantly, protect the public from harmful drugs,” they argued.

The Biden administration countered that the challengers’ request to revoke mifepristone’s approval was “extraordinary and unprecedented.” Administration lawyers said they could find no case in which a court “second-guessed the FDA’s safety and effectiveness determinations and ordered the removal of a widely available FDA-approved drug from the market — much less one instance spanning two decades.” delay.”

In response to the association’s claim that the FDA improperly expedited mifepristone’s approval without sufficient evidence of its safety, Justice Department lawyers noted that the drug’s 2000 approval came more than four years after manufacturer Danco submitted its application.

The drugmaker, too, told the court that forcing the FDA to revoke mifepristone’s longstanding approval would not only “seismically disrupt the agency’s governing authority over whether a drug is safe and effective” but would also put Danco out of business.

“The public has no interest in hastily assembling, and overtly political, private parties responsible for wresting control of the drug approval process from a United States agency—an agency that has acted deliberately, thoughtfully, and in accordance with the law approving and implementing regulations.” ,” the company said.

The Biden administration has argued that serious adverse events associated with mifepristone are rare and said claims made by medical associations are speculative. They said patients would be harmed by the court order revoking the approval of mifepristone.

“Removing access to mifepristone would result in poor health outcomes for patients who depend on the availability of mifepristone to safely and effectively terminate their pregnancies,” they wrote, adding that patients would still seek legal access to abortion regardless of what the courts do.

A ban, however, would force women who want to terminate a pregnancy to do so “through an invasive medical procedure that increases health risks for some patients and may otherwise be inaccessible to others.”

The Justice Department also warned that cutting off access to mifepristone would threaten the capacity of state health care systems, as it would lead to more patients undergoing surgical abortions at clinics already under pressure from patients traveling from states with restrictive abortion laws for care.

“This will lead to delays for health care services as providers and resources are diverted unnecessarily to surgical abortions,” they say.

The battle lines drawn in the dispute over the abortion pill mirror other court battles involving abortion.

A coalition of 22 red states that tightened abortion restrictions after the Supreme Court reversed Roe sided with anti-abortion rights groups and accused the FDA of violating federal law.

The agency relied on a regulation that allows it to approve new drugs that treat “serious or life-threatening illnesses” but that early pregnancy is not an “illness” or a condition that is not “serious or life-threatening,” the attorney said. General argued for Republican-led states.

“The FDA and the administration as a whole have no intention of respecting the Constitution, the Supreme Court, or the democratic process when it comes to abortion,” they claimed in the brief for friends of the court.

Supporting the FDA and the Biden administration are 21 blue states and the District of Columbia. Officials in these jurisdictions argued that the continued availability of mifepristone was important to protect the health, safety and rights of their residents.

“The consequences of revoking the FDA’s approval of medication abortion — currently the most common method of obtaining an early abortion — would be nothing short of catastrophic, sending shock waves across the country,” they wrote in court.

Democratic-led states have said that without medication abortion options, patients will be forced to turn to other methods or delay care.

“The more access to abortion is denied, the more unnecessary and heartbreaking outcomes can be expected to increase, with damaging effects on communities of color,” the Democratic attorney general said.

According to the Centers for Disease Control and Prevention, medication abortions accounted for more than half of all abortions in the United States in 2020, and two-drug protocols are 98% effective in terminating pregnancies up to 10 weeks’ gestation.

Under the regimen, a patient would first take mifepristone, which blocks progesterone, the hormone necessary for pregnancy to develop. This is followed by a dose of misoprostol, which is approved for the treatment of gastric ulcers and causes contractions.

Anticipating an order blocking access to mifepristone, abortion providers Preparing to offer Misoprostol-only abortion.

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