How recent lawsuits could affect access to abortion pills

By Brendan Pierson

(Reuters) - Medication abortion has been in the spotlight since the U.S. Supreme Court last June reversed its landmark 1973 ruling in Roe v. Wade, which had guaranteed abortion rights nationwide. A lawsuit has been filed to get the drug used in the procedure pulled from the market, while two others seek to expand access to it. Below is a guide to what is at stake.

WHAT IS MEDICATION ABORTION?

Medication abortion, which accounts for more than half of U.S. abortions, is a two-drug regimen consisting of mifepristone followed by misoprostol used to terminate a pregnancy within the first 10 weeks.

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.

Two separate lawsuits were filed last month seeking to expand access to mifepristone. In one, 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 other, 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.

Both 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 will go before 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.

WHAT WOULD HAPPEN NEXT?

The FDA would seek an emergency stay of the 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?

The timing of Kacsmaryk's ruling is uncertain. The judge has asked both sides to submit filings by Friday saying whether he should hold a hearing on a preliminary injunction, or skip directly to a full trial on the merits of the case. He has allowed the maker of brand-name mifepristone, Danco Laboratories LLC, to submit its own filing opposing the injunction, and has given the plaintiffs until Feb. 24 to respond to the company.

Kacsmaryk could schedule a hearing or trial not long after receiving those filings.

WHAT ABOUT THE LAWSUITS IN WEST VIRGINIA AND NORTH CAROLINA?

Both lawsuits delve into largely uncharted areas of law, making it hard to predict the outcomes. But the North Carolina lawsuit likely has a better chance of success.

Federal preemption for prescription drugs has been tested in court once before, when Massachusetts tried to ban an FDA-approved opioid pain medicine. A court struck down that ban on preemption grounds. The same reasoning would seem to prevent states from imposing extra safety rules on mifepristone, beyond those imposed by the FDA, legal experts have said.

The West Virginia lawsuit makes a more novel legal argument, since West Virginia's abortion ban applies to all abortions and does not specifically regulate mifepristone.

GenBioPro nonetheless argues that it should be treated as a ban on mifepristone, since it has the practical effect of stopping sales of the drug, and is therefore preempted. But the state will likely counter that it has the power to regulate abortion, regardless of how it is performed.

COULD THERE BE MORE LEGAL ACTION?

Many observers believe there will be. In what may be a sign of what lies ahead, a group of Republican attorneys general on Feb. 1 warned major pharmacies that sending mifepristone pills by mail could run afoul of state and federal law. Texas a week later sued the Biden administration over its direction to pharmacies that they cannot refuse to fill prescriptions for drugs that could be used to terminate pregnancy.

(Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and Bill Berkrot)