Texas judge blocks FDA approval of abortion – POLITICO

Meanwhile, the Washington State federal judge Friday night published in the order of disagreement that prevents the FDA from revoking public access to the twelve blue states that brought the lawsuit.

U.S. District Court Judge Thomas O. Rice, appointed by former President Barack Obama, disagreed with Kacsmaryk, who ordered the FDA to maintain the status quo, removing the possibility that it could go before the Supreme Court.

Kacsmaryk’s decision, for his part, is a sweeping confirmation of arguments from anti-abortion groups and debated by the government and major medical groups that the FDA has not adequately considered potential safety risks.

Retracting arguments that it is inappropriate to allow a challenge to a drug that has been approved for decades, he also wrote that the FDA “stonewalls judicial review” and “neglected” requests from anti-abortion organizations to revoke its approval.

The judge’s ruling included language commonly used by anti-abortion advocates, referring to abortion as “killing the unborn,” referring to abortion providers as “abortionists” and describing the “intense psychological trauma” of people who use them. pillage and then see “the remains of her aborted children.”

Almost a quarter of the states banned abortion, almost all after eight months goat v. Wade But this decision has been overturned, potentially affecting pregnant women across the country — even in Democratic states that have prioritized access to abortion.

The pill, which the FDA approved for use before 10 weeks of pregnancy more than two decades ago, has recently become the most common method of abortion in the United States, and has been circumvented by many states since the Supreme Court overturned it. goat v. Wade last June

Both abortion supporters and opponents have focused on the pill in recent months – leading to battles between state legislatures, regulatory agencies and the courts.

‘A dangerous example’;

The Justice Department quickly appealed the case to the 5th US Circuit Court of Appeals on Friday night, and top members of the Biden administration said that protecting the FDA’s authority and access to public information is a top priority.

“If this ruling stands, there will be virtually no FDA-approved prescription that is safe from these types of ideological political attacks,” President Joe Biden said in a statement Friday night, citing widespread concerns in the state. providers to encourage other legal challenges to approved drugs, including vaccines and contraception. “My Administration will fight this ruling.”

Attorney General Merrick Garland also weighed in Friday evening, saying that while the Justice Department “strongly disagrees” with the Texas decision and is appealing, the DOJ is still reviewing the Washington State ruling. In both cases, he stressed, the administration is “committing to protecting Americans’ access to legitimate reproductive health care.”

The anti-abortion group that brought the challenge, meanwhile, welcomed Kacsmaryk’s ruling Friday night, calling it a “significant victory” and insisting on a call with reporters that if the higher courts did not intervene next week, the two pharmaceutical companies that make the pill “would stop production of this drug.”

Eric Baptista, a senior counsel with the Liberty Defense League, which argued the case in Texas for anti-abortion medical groups, declined to comment on Washington State’s ruling that protects access to drugs, but said the case “maybe. It will necessarily go to the Supreme Court.”

Baptista also rejects accusations that his organization is “judge shopping,” filing a case where the group knew it would come before Kacsmaryk, who — before being confirmed on the federal bench in 2019 — was a lawyer for the First Freedom Institute, a. legal advocacy of a conservative Christian college. He argued that some of the doctors involved in the case were based in Amarillo, Texas, and were recently impacted by the pills, having the resources to separate patients who took them and needed care.

In oral arguments in March, anti-abortion doctors and individual medical professionals who represented them claimed that the FDA erred in approving the drug and did not adequately consider the risks to their health — a position Kacsmaryk cited in his ruling.

“Medical adverse events from chemical abortion can overwhelm the medical system and consume significant medical resources, including blood for transfusions, physician time and attention, space in hospitals and medical centers, and other equipment and medications,” American Association of Pro-Life Obstetricians & Gynecologists, Christian Medical & Dental Associations and other Organizations claimed in their sect. “The more patients suffering from complications from chemical abortion drugs emergency or drug side effects to treat, the less time and attention doctors have to treat other patients.”

The Justice Department asked Kacsmaryk to dismiss the case, saying doctors and medical groups do not have standing and are not trying to “hang out.” [the FDA’s] the long-term scientific determination is based on speculative allegations of damage. The DOJ also argued that the group was well past the pre-set limits for challenging the 2,000 pills, saying they could only proceed after recent agency actions that loosened restrictions on how patients could obtain them.

The 2021 and 2023 rule changes that allowed patients with prescriptions to receive medications electronically and pick them up at retail pharmacies were based on “multiple studies that have shown that drug administration is associated with high rates of serious adverse events.” The DOJ took the matter to court. The FDA first allowed the telemedicine prescription of remedies just for the duration of the Covid-19 pandemic and later moved to base ongoing regulations on the new safety data.

Danco, the manufacturer of the drug, also intervened as a party in the case, arguing that the lawsuit threatens “the financial health of the company.” The company said it would immediately appeal the order, calling it “a dark day for public health.”

Democratic state attorneys general joined forces with the Biden administration in the Texas case, but a dozen of them sided with government lawyers in the case of the FDA in Washington, arguing that the remaining federal limitations on drugs without science and hindered the states’ ability to treat patients who need the drug.

The lawsuit was co-led by Bob Ferguson and Oregon’s Ellen Rosenblum in Washington, along with Democratic attorneys general from Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.

Judge Rice has not yet ruled in a challenge to REMS – or Risk Evaluation & Mitigation Strategies – that the FDA places on a narrow class of drugs, including requirements that patients sign a “patient agreement form” acknowledging the risks of the drug and that health care providers who prescribe the drug must first obtain certification and prove that it is accurate pregnancies, the diagnosis of ectopic pregnancies and provides or arranges for care, if the case occurs, it follows.

The potential impact of the Texas ruling

If Kacsmaryk’s ban eventually takes effect, some parts of the country could be hit particularly hard. Analysis by the Guttmacher Institute, an abortion rights think tank found that abortion clinics in 2 percent of US counties only offer abortion pills and do not have a procedural option. Some of the states that have been most impacted — including Colorado, Pennsylvania and New Mexico — are serving their own residents, and have a large influx of patients from neighboring states with shortages. Guttmacher estimates that the plan could prevent access to at least 2.4 million people.

Some abortion providers have announced that they are willing to prescribe the second pill in a two-pill regimen — misoprostol, in the event that mifepristone is banned. The drug is subject to a few limitations, since it is used for many non-abortive purposes, including for the treatment of stomach ulcers. Misoprostol-only abortions are also common in other countries, but slightly more pregnant patients have surgery to complete the abortion than two pills used at the same time.

“We’re preparing for the next several weeks, putting together plans and policies that will go into effect if the ruling mifepristone is reviewed,” Ashley Brink, director of the Women’s Trust’s abortion clinic in Wichita, Kansas, told reporters in February. “We’ve had our doctors teach us how to advise patients about what to expect and we’ve met with our attorneys about legal exposure.”

“However,” he emphasized, “not every clinic can turn as quickly as possible to a misoprostol-only protocol.”

If the decision to ban mifepristone is allowed to stand, the FDA could approve it again if it receives a new application from the pharmaceutical company — a process that could take months if not years.

Abortion rights advocacy groups warn that the decision could also open the door to a wide range of ideologically motivated challenges to anything from birth control to vaccines.

“Most of the risk is people’s access to medication that they rely on,” Porter Flaxman, an attorney for the parenting organization, said in an interview. “If someone is allowed to come back decades later, and the medication is going to be safe.”

Josh Gerstein contributed to this report.