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Evening Standard
Evening Standard
World
Miriam Burrell

US abortion pill access in doubt after Texas judge suspends approval

Access to common abortion bills in the US plunged into uncertainty after conflicting court rulings were issued over the legality of medication widely available for more than 20 years.

Abortion medication mifepristone - approved by the Food and Drug Administration (FDA) in 2000 - was blocked Donald Trump appointee US District Judge Matthew Kacsmaryk, who ordered a hold on federal approval of mifepristone in Texas as part of a decision that overruled decades of scientific approval.

But that decision came at nearly the same time that US District Judge Thomas O Rice, an Obama appointee in Washington, directed US authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats sued in an effort to protect availability.

The timing of the competing orders revealed the high stakes surrounding the drug nearly a year after the US Supreme Court overturned Roe v Wade and curtailed access to abortion across the country.

President Joe Biden said his administration would fight the Texas ruling.

Adding: “Let’s be clear - the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe versus Wade.

“Vice President Kamala Harris and I will continue to lead the fight to protect a woman’s right to an abortion, and to make her own decisions about her own health.”

Abortion providers slammed the Texas ruling, including Whole Woman’s Health, which operates six clinics in five states and said it would continue to dispense mifepristone in person and by mail over the next week as they review the rulings.

“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.

Matthew Kacsmaryk (AP)

The abortion drug has been widely used in the US since securing FDA approval and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration.

Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.

Mr Kacsmaryk signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues.

His 67-page order gave the government seven days to appeal.

“The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” Mr Biden said.

“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”

Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol.

That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.

The lawsuit in the Texas case was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned.

At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.

Since the Texas lawsuit was filed in November, legal experts have warned of questionable arguments and factual inaccuracies in the Christian group’s filing.

Mifepristone has been used by millions of women over the past 23 years, and complications from mifepristone occur at a lower rate than that seen with wisdom teeth removal, colonoscopies and other routine medical procedures, medical groups have recently noted.

In late 2021 the FDA - under the Biden administration - dropped a requirement that women pick up the drug in person, opening the door to delivery by mail-order pharmacies.

In January the agency dropped another requirement that prevented most brick-and-mortar pharmacies from dispensing the pill.Anti-abortion groups embraced the Texas ruling.

“The court’s decision today is a major step forward for women and girls whose health and safety have been jeopardized for decades by the FDA’s rushed, flawed and politicised approval of these dangerous drugs,” said March for Life President Jeanne Mancini.

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