US Supreme Court suspends abortion pill restrictions

by The Insights

The U.S. Supreme Court will allow a drug used in more than half of the nation’s abortions to remain available while a decades-long legal battle over its regulatory approval unfolds in lower courts.

The court on Friday overturned a decision by Texas federal judge Matthew Kacsmaryk, who earlier this month suspended the authorization of mifepristone while the appeal process continues.

This decision is a victory for the US government and the pharmaceutical industry in their legal fight against the abortion drug. The Justice Department and Danco Laboratories, which manufactures mifepristone, challenged the Texas decision, which suspended regulatory approval of mifepristone granted more than 20 years ago, effectively resulting in a nationwide ban.

A federal appeals court then stayed most of Texas’ decision. This allowed servings — which effectively reinstated mifepristone dispensing limits that the Food and Drug Administration had been gradually relaxing since 2016 — to take effect during the appeals process.

Judge Samuel Alito had twice extended the deadline for the court to decide on the appeal to the high court. On Friday, the majority of the court agreed to stay Texas’ decision for the time being. But Alito and fellow Tory Justice Clarence Thomas said they would have denied the request.

Alito wrote in his dissent that the petitioners “have not demonstrated that they are likely to suffer irreparable harm” while the case continues.

It is the latest step in a legal battle that has caused upheaval in abortion care across the country after the Supreme Court last year overturned Roe vs Wade, which enshrined the constitutional right to the procedure for almost five decades.

US President Joe Biden said in a statement after the decision: “I continue to uphold the FDA’s evidence-based approval of mifepristone, and my administration will continue to uphold the FDA’s independent and expert authority to review , approving and regulating a wide range of prescription drugs.

“The stakes couldn’t be higher for women across America.”

Pro-abortion groups welcomed the court order, but warned that the legal battle over a case they deemed unfounded was not over. “The Supreme Court’s decision is a huge relief, but we’re not off the hook yet,” said Nancy Northup, president of the Center for Reproductive Rights.

“For now, providers and patients can rest assured that mifepristone is available and remains an FDA-approved drug. But we shouldn’t even be here. This case should have been thrown out long before it came to the Supreme Court,” Northup added.

The Texas decision has rattled abortion advocates and providers as well as mifepristone producers. The US government had said it “raises a whole host of unprecedented issues”. It has also raised concerns about the courts’ ability to more broadly challenge regulatory decisions that have been in effect for years.

Carrie Flaxman, senior director of public policy litigation at Planned Parenthood, a nonprofit group providing abortion care, said removing mifepristone pills would have had a “devastating impact” on abortion care. abortion. Healthcare groups face a “chaotic and confusing” situation because they don’t know what kind of care they can provide to patients on a daily basis, she added.

“The biggest impact is on patients, who are trying to navigate access to care,” Flaxman said. “There is a lot of confusion about the status of abortion and medical abortion.”

One potential option for healthcare providers is to offer patients a different drug, misoprostol, she added. Although typically given in combination with mifepristone in medical abortions, misoprostol is safe and effective when used alone and has been offered in other countries, Flaxman said.

“But to be clear, it’s not a simple thing for the healthcare community that has relied on one drug, one regimen, for over 23 years just to turn a penny and be able to provide care,” she added.

The pharmaceutical industry said the restrictions proposed by the Texas decision ignore decades of scientific evidence and legal precedent and, if implemented, would cause regulatory chaos.

Danco, a leading maker of abortion pills containing mifepristone, said the restrictions may force it to stop selling the drug and halt its operations. GenBioPro, the maker of a generic version of abortion pills containing mifepristone, filed a lawsuit this week seeking to allow it to continue selling its pill amid ongoing legal battles.

Amanda Banks, an adviser at Harbinger Health, was one of more than 700 pharmaceutical executives who signed an open letter condemning the Texas decision, said the industry would continue to advocate for the FDA’s authority to regulate new medicines and the ability of patients to access these medicines. .

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