Supreme Court keeps mifepristone available without restrictions


Protesters gather in support of abortion rights outside the US Supreme Court in Washington, DC on April 15, 2023.

Andrew Caballero-Reynolds | AFP | Getty Images

On Friday, the Supreme Court ordered the abortion pill mifepristone to remain widely available as the litigation unfolds in a lower court.

The High Court’s decision followed an urgent request from the justice department to block lower court rulings that would severely limit access to drugs, even in some states where abortion remains legal.

The case will now be heard in the United States Court of Appeals for the 5th Circuit. The appeals court has scheduled oral arguments for Wednesday, May 17 at 1 p.m. CT.

Mifepristone has become the focal point of the legal battle against abortion since the Supreme Court last summer overturned Roe v. Wade, the landmark 1973 decision that guaranteed abortion as a constitutional right nationwide.

Mifepristone, used in combination with another drug called misoprostol, is the most common method of terminating a pregnancy in the United States, accounting for about half of all abortions.

President Joe Biden said the Supreme Court ruling keeps mifepristone available to women and the FDA has approved termination of teenage pregnancies. Biden said his administration will continue to protect access to mifepristone in the ongoing legal battle in the 5th Circuit Court of Appeals.

“I continue to defend the FDA’s evidence-based approval for mifepristone, and my administration will continue to defend the independent, expert authority of the FDA to review, approve, and regulate a wide range of prescription drugs,” he said. Biden said.

Justices Samuel Alito and Clarence Thomas, both conservatives, opposed the Supreme Court’s majority decision to grant the emergency request from the Biden administration and Danco Laboratories, the distributor of the branded version of the medication, Mifeprex.

The Justice Department and Danco, in their emergency petitions, told the Supreme Court that restrictions imposed by lower courts would effectively take mifepristone off the market for months, with the FDA adjusting the drug’s labeling to comply. to prescription. It would prevent women from having access to an FDA-approved drug that is a safe alternative to surgical abortions, they argued.

Alito rejected this argument in his dissent. The court said the FDA could simply use its enforcement discretion as the litigation unfolded and allow Danco to continue distributing mifepristone.

The nationwide legal battle over mifepristone began with a lawsuit brought by a coalition of doctors who oppose abortion, the Hippocratic Medicine Alliance. These doctors sought to force the Food and Drug Administration to remove the drug from the United States entirely.

Earlier this month, U.S. District Judge Matthew Kacsmaryk ruled in favor of anti-abortion doctors and issued a sweeping order that would have halted sales of mifepristone nationwide.

A few days later, the United States Court of Appeals for the Fifth Circuit blocked part of Kacsmaryk’s prescription and allowed the brand name version of the drug, Mifeprex, to remain on the market. But the appeals court judges imposed restrictions on the drugs that would severely limit access.

The appeals court blocked delivery of the drug by post, made doctor visits a condition for obtaining the drug, and reduced the length of time women can take the pill to the seventh week of pregnancy.

Appeals court judges also suspended approval in 2019 of the generic version of mifepristone. The company that sells the generic version, GenBioPro, told the Supreme Court that the majority of the nation’s drug supply would “disappear overnight” if the appeals court ruling goes into effect.

GenBioPro claims to supply two-thirds of mifepristone used in abortions in the United States

CNBC Health and Science

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