US: Supreme Court keeps FDA abortion pill rules in place for now

The Supreme Court said Friday it was temporarily keeping in place federal rules for use of an abortion drug, while it takes time to more fully consider the issues raised in a court challenge.

In an order signed by Justice Samuel Alito, the court asked both sides to weigh in by Tuesday over whether lower court rulings restricting the Food and Drug Administration's approval of the drug, mifepristone, should be allowed to take effect while the case works its way through federal courts.

The order suggests the court will decide that issue by late Wednesday.

The justices are being asked at this point only to determine what parts of an April 7 ruling by US District Judge Matthew Kacsmaryk in Texas, as modified by an appellate ruling Wednesday, can be in force while the case continues.

The Biden administration and New York-based Danco Laboratories, the maker of the pill, asked the justices to intervene.

The type of order issued by the court Friday, an administrative stay, ordinarily is not an indication of what the justices will do going forward.

The Biden administration and a drug manufacturer asked the Supreme Court on Friday to preserve access to an abortion drug free from restrictions imposed by lower court rulings, while a legal fight continues.

The Justice Department and Danco Laboratories both warned of “regulatory chaos” and harm to women if the high court doesn't block an appeals court ruling in a case from Texas that had the effect of tightening Food and Drug Administration rules under which the drug, mifepristone, can be prescribed and dispensed.

The new limits would take effect Saturday unless the court acts before then.

A lawyer for the anti-abortion doctors and medical organizsations suing over mifepristone said the justices should reject the drugmaker's and the administration's pleas and allow the appeals court-ordered changes to take effect.

The fight over mifepristone lands at the Supreme Court less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.

The justices are being asked for a temporary order to keep in place Food and Drug Administration regulations governing mifepristone.

Such an order would give them time to more fully consider each side's arguments without the pressure of a deadline.

The Biden administration and Danco, which is based in New York, also want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues.

As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year.

The court rarely acts so quickly to grant full review of cases before at least one appeals court has thoroughly examined the legal issues involved.

A ruling from the 5th U.S. Circuit Court of Appeals late Wednesday would prevent the pill, used in the most common abortion method, from being mailed or prescribed without an in-person visit to a doctor.

It also would withdraw the Food and Drug Administration's approval of mifepristone for use beyond the seventh week of pregnancy. The FDA says it's safe through 10 weeks.

Still, the appeals court did not entirely withdraw FDA approval of mifepristone while the fight over it continues. 

The 5th circuit narrowed an April 7 ruling by U.S. District Judge Matthew Kacsmaryk, whose far-reaching and virtually unprecedented order would have blocked FDA approval of the pill. He gave the administration a week to appeal.

Erin Hawley, a lawyer for the challengers, said in a statement that the FDA has put politics ahead of health concerns in its actions on medication abortion.

Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.

Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to make clear that the FDA is not to do anything that might block mifepristone's availability in 17 Democrat-led states suing to keep it on the market.

It's unclear how the FDA can comply with court orders in both cases, a situation that Prelogar described Friday as untenable.