By Brendan Pierson
(Reuters) – A federal judge in Texas held a hearing on Wednesday in a case seeking to ban the abortion drug mifepristone nationwide, while at least three other lawsuits seek to expand access to it. Below is a guide to what is at stake.
WHAT IS MEDICATION ABORTION?
Medication abortion is a two-drug regimen consisting of mifepristone followed by misoprostol used to terminate a pregnancy within the first 10 weeks. Medication abortion, which accounts for more than half of U.S. abortions, has been under increasing scrutiny since the U.S. Supreme Court last June reversed its landmark 1973 ruling in Roe v. Wade, which had guaranteed abortion rights nationwide.
WHAT ARE THE LAWSUITS?
Last November, anti-abortion groups sued the U.S. Food and Drug Administration in Amarillo, Texas, federal court, claiming that the agency was wrong to approve mifepristone in 2000 because it did not adequately consider its safety. The groups are asking for a preliminary order, or injunction, undoing the FDA’s approval while the lawsuit proceeds.
Meanwhile, at least three separate lawsuits were filed earlier this year seeking to expand access to mifepristone.
In February, twelve Democratic state attorneys general sued the FDA to challenge the agency’s requirement that doctors who prescribe it, and pharmacies that dispense it, obtain a special certification, arguing those limits were not supported by evidence.
In another lawsuit in West Virginia, generic mifepristone maker GenBioPro is asking a federal judge to block West Virginia, which has a near-total abortion ban, from prohibiting sales of the pills.
In the third lawsuit, a North Carolina doctor is seeking to block that state’s restrictions on the drug, which include requirements that it be obtained in person from a physician at specially licensed facilities following mandatory counseling. The state is one of 16 that allow abortion under some circumstances, but impose additional restrictions on mifepristone that make it harder to access.
The West Virginia and North Carolina lawsuits rely on a long-established legal doctrine known as federal preemption, under which federal law – in this case, the FDA’s authority to approve and regulate drugs – overrides conflicting state law.
WHAT WOULD HAPPEN IF THE TEXAS PLAINTIFFS WIN?
A plaintiffs’ victory in Texas could completely remove mifepristone from the market nationwide, since federal judges have the power in some cases to issue injunctions that reach beyond their own districts to encompass the whole country. The FDA said in a recent court filing that pulling the drug off the market would dramatically harm patients, forcing them to have unnecessary, and sometimes riskier, surgical abortions and subjecting them to long wait times.
Abortion providers have raised the possibility of prescribing misoprostol alone for medication abortion, which is not a use approved by the FDA but is in some other countries. Such off-label prescribing is generally legal, but it is not clear how many providers would adopt it.
IS A WIN BY TEXAS PLAINTIFFS LIKELY?
Legal experts say that challenging FDA approval long after the fact on alleged safety grounds has no obvious precedent, and the plaintiffs will need to show a legal reason to overcome the normal six-year statute of limitations.
By filing in Amarillo, however, the plaintiffs have ensured that their case went to U.S. District Judge Matthew Kacsmaryk, an outspoken conservative appointed to the federal bench by former Republican President Donald Trump, who has been friendly to conservative causes in past cases.
During Wednesday’s hearing, Kacsmaryk thoroughly questioned both sides but did not clearly signal how he would rule. He raised the possibility of a narrower order than the plaintiffs are seeking, which could leave the drugs on the market, but reimpose restrictions lifted by the Biden administration, including a requirement that mifepristone be dispensed in person.
WHAT WOULD HAPPEN NEXT?
The FDA would seek an emergency stay of any injunction while it appeals to the 5th U.S. Circuit Court of Appeals. That court is also known as conservative, with a majority of judges appointed by Republicans. But some abortion rights advocates have said they believe it would be more cautious about pulling an FDA-approved drug. Whichever way the 5th Circuit rules, the case is likely to then be appealed to the U.S. Supreme Court.
WHEN COULD THERE BE A RULING?
Kacsmaryk said at the March 15 hearing that he would rule as soon as possible.
(Reporting by Brendan Pierson in New York; Editing by Alexia Garamfalvi, Bill Berkrot and Matthew Lewis)