By Brendan Pierson
(Reuters) – Medical abortion has been in the spotlight since the US Supreme Court delivered its landmark 1973 Roe v. Wade, which had guaranteed abortion rights nationwide. A lawsuit has been filed to take the drug used in the process off the market, while two others are trying to expand access to it. Below is a guide to what’s at stake.
WHAT IS MEDICATED ABORTION?
Medical abortion, which accounts for more than half of abortions in the US, 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 US Food and Drug Administration in federal court in Amarillo, Texas, alleging that the agency wrongly approved mifepristone in 2000 for failing to adequately consider its safety. The groups are asking for a temporary restraining order or injunction to overturn the FDA’s approval during the proceeding.
Two separate lawsuits were filed last month to expand access to mifepristone. In one case, GenBioPro, makers of generic mifepristone, is asking a federal judge to stop West Virginia, which has a near-total abortion ban, from banning the pills’ sale.
In the other, a North Carolina doctor is trying to block that state’s restrictions on the drug, which include a requirement that it be obtained in person from a doctor at specially licensed facilities after mandatory consultation. The state is one of 16 states that allow abortions in certain circumstances but impose additional restrictions on mifepristone that make access difficult.
Both draw on a long-established legal doctrine known as federal prevention, according to which federal law — in this case, the FDA’s power to approve and regulate drugs — takes precedence over conflicting state laws.
WHAT WOULD HAPPEN IF THE TEXAS PLAINTIFFS WIN?
A Texas plaintiffs victory could remove mifepristone entirely from the market statewide, as federal judges in some cases have the power to issue injunctions that extend beyond their own counties and span the entire country. The FDA said in a recent lawsuit that withdrawing the drug from the market would dramatically harm patients, force them to have unnecessary and sometimes riskier surgical abortions, and expose them to long waiting times.
Abortion providers have raised the possibility of prescribing misoprostol alone for medical abortion, which is not an FDA-approved use but is in some other countries. Such off-label prescribing is generally legal, but it’s not clear how many providers would adopt it.
ARE TEXAS PLAINTIFFS LIKELY TO WIN?
Legal experts say there is no apparent precedent for challenging FDA approval long after the fact on alleged safety grounds, and plaintiffs must show a legal basis to get past the normal six-year statute of limitations.
However, by filing in Amarillo, plaintiffs have ensured their case will be heard before U.S. District Judge Matthew Kacsmaryk, an outspoken conservative appointed to the Federal Bank by former Republican President Donald Trump, who has been friendly to conservative concerns in previous cases was.
WHAT WOULD HAPPEN NEXT?
The FDA would seek an immediate stay of the injunction while it appeals to the US Fifth Circuit Court of Circuits. This 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 prudent to take an FDA-approved drug. Regardless of how the 5th federal court decides, the case will likely be appealed to the US Supreme Court.
WHEN COULD IT REACH A DECISION?
The timing of Kacsmaryk’s verdict is uncertain. The judge has asked both sides to submit papers by Friday saying whether to hold a restraining order hearing or proceed directly to a full trial on the matter. He has allowed the maker of the brand name mifepristone, Danco Laboratories LLC, to file its own request against the injunction and has given the plaintiffs until February 24 to respond to the company.
Kacsmaryk could schedule a hearing or trial shortly after receiving these documents.
WHAT ABOUT THE LAWSUITS IN WEST VIRGINIA AND NORTH CAROLINA?
Both lawsuits address largely unexplored areas of law, making it difficult to predict outcomes. But the North Carolina lawsuit likely has a better chance of success.
The state’s prescription drug first refusal was previously tested in court when Massachusetts tried to ban an FDA-approved opioid pain reliever. A court lifted this ban for reasons of pre-emption. The same reasoning appears to prevent states from imposing additional safety regulations on mifepristone beyond those imposed by the FDA, legal experts said.
The West Virginia lawsuit provides a more novel legal argument because the West Virginia 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 because it has the practical effect of stopping sales of the drug and is therefore anticipated. But the state is likely to counter that it has the power to regulate abortion, regardless of how it’s performed.
COULD THERE BE MORE LEGAL ACTION?
Many observers assume so. In what could be a sign of what lies ahead, a group of Republican attorneys general warned major pharmacies on Feb. 1 that mailing mifepristone pills through the mail could violate state and federal law. Texas sued the Biden administration a week later for ordering pharmacies not to 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)
