Supreme Court keeps mifepristone fully available

The Supreme Court on Friday ordered the abortion pill mifepristone to remain broadly available as litigation plays out in a lower court.

The high court’s decision came in response to an emergency request by the Department of Justice to block lower court rulings that would severely limit access to the medication even in some states where abortion remains legal. 

related investing news

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

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

Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions.

President Joe Biden said the court’s decision keeps mifepristone available to women and FDA approved to terminate early pregnancies. Biden said his administration will fight to protect access to mifepristone in the ongoing legal battle in the 5th Circuit Court of Appeals.

“I continue to stand by [the Food and Drug Administration’s] evidence-based approval of mifepristone, and my administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” the president said.

Planned Parenthood President Alexis McGill Johnson said the reproductive health-care provider is relieved by the Supreme Court’s decision.

But McGill Johnson warned that access to  mifepristone remains in jeopardy as the legal battle plays out in the appeals court.

“While mifepristone’s approval remains intact and it stays on the market for now, patients and health care providers shouldn’t be at the mercy of the court system,” McGill Johnson said. “Medication abortion is very much still under threat — as is abortion and access to other sexual and reproductive health care.”

Justices Samuel Alito and Clarence Thomas, both conservatives, opposed the court’s majority decision to grant the emergency request from the DOJ and Danco Laboratories, the distributor of the brand-name version of the drug, Mifeprex.

The DOJ and Danco, in their emergency requests, told the Supreme Court the restrictions imposed by the lower courts would effectively take mifepristone off the market for months as the FDA adjusted the medication’s labelling to comply with the orders. This would deny women access to an FDA-approved drug that is a safe alternative to surgical abortions, they argued.

Alito rejected that argument in his dissent. The justice said the FDA could simply use its enforcement discretion as the litigation played out and allow Danco to continue distributing mifepristone.

The court’s majority decision to maintain the status quo means mifepristone remains available by mail delivery, and women can obtain the prescription medication without having to visit a doctor in person.

However, in the dozen states that have effectively banned abortion over the past year, the drug will remain largely unavailable. Other states also have restrictions in place that are much tighter than FDA regulations.

The national legal battle over mifepristone began with a lawsuit filed by a coalition of doctors who oppose abortion, the Alliance for Hippocratic Medicine. Those doctors sought to force the FDA to pull the medication from the U.S. entirely.

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

Days later, the U.S. Fifth Circuit Court of Appeals blocked part of Kacsmaryk’s order and allowed Mifeprex to remain on the market. But the appeals court judges imposed restrictions on the medication that would severely limit access.

The appeals court blocked mail delivery of the drug, imposed doctors’ visits as a condition to get the medication, and reduced the length of time when women can take the pill to the seventh week of pregnancy. 

The appeals court judges also suspended the 2019 approval of the generic version of mifepristone. The company that sells the generic version, GenBioPro, told the high court the majority of the nation’s supply of the medication would “disappear overnight” if the appeals court ruling went into effect. 

GenBioPro said it supplies two-thirds of the mifepristone used in abortions in the U.S.