Doubts about access to abortion pills in the US after a Texas judge suspended approval | miscarriage

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A Texas federal judge on Friday suspended US approval of the abortion drug mifepristone, one of two drugs commonly used for medical abortion, in a closely watched case brought by anti-abortion activists.

But soon after, a conflicting ruling came out of Washington state, ordering the FDA to refrain from taking any action that would affect the availability of birth control pills. The two rulings throw the drug’s future into question, increasing the chances that the Supreme Court will ultimately decide its fate.

The Texas decision, a preliminary injunction issued by US District Judge Matthew J. Kacsmarek, ordered the FDA to halt approval of mifepristone during a litigation challenging the drug’s proceeds safety and approval.

However, his ruling did not go into effect immediately, because it gives the federal government seven days to appeal, and federal attorneys representing the FDA are expected to do so quickly.

In a statement condemning the Texas ruling, Attorney General Merrick Garland said: “The Department of Justice strongly disagrees with the District Court’s decision for the North District of Texas in Alliance for Hippocratic Medicine v. FDA and will appeal the court’s decision and seek to have the decision remain pending appeal. Today overturns the FDA’s expert judgment, made more than two decades ago, that mifepristone is safe and effective.”

Vice President Kamala Harris said in a statement that the ruling “threatens the rights of women across the country to make decisions about their health care and to be able to obtain the medications prescribed by their doctors.”

Washington’s conflicting decision came in a lawsuit filed by Democratic state attorneys general seeking to remove federal restrictions on how birth control pills are distributed.

The case of Texas v. Food and Drug Administration was brought by Alliance Defending Freedom (ADF), a conservative Christian legal advocacy group, arguing that the FDA overstepped its regulatory authority when it approved mifepristone more than two decades ago, in 2000.

The Trump-appointed judge did not go as far as the plaintiffs wanted to withdraw approvals for chemical abortion drugs and remove them from the list of approved drugs. But he stopped or stopped approving the drug.

The plaintiffs included widely disputed claims in their case, arguing that the FDA’s decision to extend the gestational age so mifepristone could be prescribed put pregnant women and girls at risk; And that the FDA’s 2021 decision to remove the requirement for personal dispensing of mifepristone during the pandemic puts pregnant women at risk. They also alleged that the FDA “failed to recognize and address federal laws prohibiting the distribution of chemical abortion drugs by regular mail,” citing a 19th-century law that made it illegal to mail “obscene, corrupt, or corrupt” materials. , including pornography and abortion.

“Simply put, judicial review has been blocked by the Food and Drug Administration — until now,” Kaksmarek wrote in his 67-page ruling.

Mifepristone has been repeatedly found to be safe and effective and is used worldwide. The Joe Biden administration, in response to the lawsuit, said that approval of the drug was well-supported by science and that the challenge for the FDA was coming too late.

The US Department of Justice also argued that a ruling in favor of the plaintiffs would undermine confidence in the Food and Drug Administration, the agency that oversees the safety of food products and drugs in the United States and would overburden already overcrowded surgical abortion clinics. Women coming from countries where abortion is now prohibited.

A protester outside the federal courthouse in Amarillo, Texas as Judge Matthew J. Kaksmarek hears a motion by anti-abortion groups. Photo: Reuters

The FDA warned in legal arguments in January that a decision in favor of the ADF would lead to “a long-term scientific determination based on speculative claims of harm,” and “would upend the status quo and endorsement interests of patients and physicians who rely on mifepristone, as well as companies involved in the drug.” Area of ​​distribution of mifepristone”.

Jenny Ma, senior counsel at the Center for Reproductive Rights, warned, “If plaintiffs can only file lawsuits like this, based on junk science, the impact goes beyond medical abortion. It really seeks to undermine the entire authority of the FDA over approval of medicines.”

Kacsmaryk, a Trump-appointed judge, is believed to have been targeted by the ADF in an operation known as “judge shopping” because of his work with far-right organizations. He previously worked at the First Liberty Institute, a conservative Christian organization focused on LGBTQ+ litigation and abortion rights.

Clinics and doctors prescribing the combination of the two drugs said that if mifepristone is pulled off the market, they will switch to using only the second drug, misoprostol. This single-drug approach has a slightly lower efficacy rate for terminating pregnancy, but is widely used in countries where mifepristone is illegal or unavailable.

The decision marks a major victory for the anti-abortion movement less than a year after the Supreme Court overturned Roe v. Wade, which guaranteed a constitutional right to abortion and led to total abortion bans in 13 states, while 16 states have laws specifically targeting abortion drugs. .

The apologists and the progressive states were bracing for the patriotic hesitations of Casmaric’s decision. The governor of Washington state said this week that he had bought a three-year supply of the leading abortion drug just in case.

Jay Inslee, a Democratic lawmaker, said he ordered the Department of Corrections, which has a pharmacy license, to purchase 30,000 doses of the generic version of mifepristone at a cost of about $1.28 million, or $42.50 per pill. The shipment arrived in late March.

“This Texas lawsuit poses a clear and present risk to patients and providers across the country,” Inslee said in a statement. Washington will not stand by and risk dire consequences for inaction.

Mifepristone is also the subject of lawsuits in West Virginia and North Carolina seeking to expand access to the drug by arguing that state restrictions conflict with federal law.

The Associated Press and Reuters contributed to this report.

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