What's at stake in abortion pill court case?

A court in New Orleans heard a case that may pull a commonly used abortion pill from the market.

A Texas judge suspended approval of the abortion drug mifepristone over safety concerns but the Supreme Court later ruled the drug could remain available while the appeals process plays out. 

The Fifth Circuit Court of Appeals will decide whether to strike down the Food and Drug Administration's (FDA) approval of mifepristone and subsequent steps to make it more accessible.

It may take months to issue a ruling, and either way, the decision will likely be appealed to the top court.

This means access to the drug will probably remain unchanged until the Supreme Court makes a final ruling or declines to hear the case.

What's at stake in this ruling?

Access nationwide to mifepristone - used in more than half of abortions in the US - will hinge on what happens during this lengthy appeals process.

The case was heard on Wednesday by the Fifth Circuit in New Orleans, which has jurisdiction over Louisiana, Texas and Mississippi.

Each side was given 40 minutes to plead their case to the three-judge panel, which includes two judges appointed by former President Donald Trump and one picked by former President George W Bush.

All three of the judges have expressed support for abortion restrictions in previous rulings.

Whichever way the Fifth Circuit decides - and that will not come soon - it's likely that the other side will appeal to the Supreme Court.

The top court is expected to take it up and have the final say because it has wide-reaching implications on national drug policy.

How the Fifth Circuit interprets the law could give an indication of the issues that the Supreme Court will take on.

How did we get here?

It began in April when a federal judge in Texas suspended FDA's approval of the drug after a group of anti-abortion health professionals sued the agency alleging mifepristone was not safe.

It was the first time in US history a court had bypassed the federal agency to rule on a drug's market approval.

The FDA and several leading health organisations, such as the American Medical Association, say the drug is safe and effective.

But this ruling said the FDA had rushed the approval and did not properly consider side effects.

Minutes later, a federal judge in Washington state issued an opposing ruling in support of the pill so the government appealed to the New Orleans-based 5th Circuit Court of Appeals.

It also asked for the court to put the Texas order on hold while the appeal was heard, keeping mifepristone available.

The appeals court agreed to keep the drug on the market - but with additional restrictions, such as only being available for use in the first seven weeks of pregnancy and requiring the drug to be dispensed in person by a physician.

That's when the Supreme Court waded in.

What did the Supreme Court decide?

The US Justice Department and Danco Laboratories, which manufactures the drug, called on the Supreme Court to intervene and strike down these restrictions while the appeal is being considered by the lower court.

It argued that the status quo should be maintained, because changing the FDA's rules would "create significant chaos for patients, prescribers, and the health care delivery system".

• How safe is the abortion pill mifepristone?

• How 'judge shopping' led to abortion-drug showdown

In April, it issued a decision allowing the drug to remain on the market without any of the restrictions imposed by the lower courts.

The Supreme Court - which has a 6-3 conservative majority - did not offer an explanation as to why. But two of the conservative judges - Justice Samuel Alito, who oversees emergency matters for the 5th Circuit, and Justice Clarence Thomas - dissented, which means they disagreed with the court's decision.

In his written dissent, Justice Alito said "at present, the applicants are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim".

What might this mean for other drugs?

Critics say that by overriding the FDA's approval, the court in Texas usurped the federal health agency's remit to regulate food, medicine, and medical devices.

The Food, Drug, and Cosmetic Act of 1938 gives the FDA the authority to determine whether drugs are safe and effective. Typically, courts have deferred to the agency when it comes to scientific and medical decision-making.

Legal experts warn the ruling opens the door for challenges to other approved medicines in the US and could also stifle development of future drugs.

• How abortion pill ruling threatens other drugs 

I. Glenn Cohen, a Harvard Law School professor, told BBC News the pharmaceutical industry could face more legal challenges, particularly to treatments that have become political flashpoints in the US, like transgender medical treatment and Covid-19 vaccines.

"It's possible in any space, but … it's going to trickle down in some ways and play out to be the worst for drugs that are needed sometimes by discrete and insular minorities," Prof Cohen said.