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The case, brought by GenBioPro, a company that makes one of two abortion drugs, argues that it is unconstitutional for a state to bar access to a medication approved by the federal government.
A company that makes an abortion pill filed a lawsuit Wednesday morning challenging the constitutionality of a state ban on the medication, the first in what is expected to be a wave of cases arguing that the federal Food and Drug Administration’s approval of the pill takes precedence over such restrictive state laws.
The case was filed in federal court in West Virginia by GenBioPro, one of two American manufacturers of mifepristone, the first pill used in the two-drug medication abortion regimen. A ruling in favor of the company could compel other states that have banned abortion to allow the pills to be prescribed, dispensed and sold, according to legal experts. If the courts reject the company’s arguments, some legal scholars say the decision could open the door for states to ban or restrict other approved drugs, such as Covid vaccines or morning-after pills.
The case is one of a number of lawsuits testing legal arguments in the aftermath of the Supreme Court’s ruling last June overturning the federal right to abortion. In November, abortion opponents filed a lawsuit challenging the F.D.A.’s approval of mifepristone nearly 23 years ago and asked that the courts order the agency to stop allowing the use of the drug and the second drug, misoprostol, for abortion.
Taken together, the cases underscore how pivotal medication abortion has become in legal and political battles. With pills now being used in more than half of abortions in America, and with recent F.D.A. decisions allowing patients to have pills prescribed by telemedicine and obtained by mail or from retail pharmacies, states that ban or restrict abortion are increasingly targeting the medication method.
The dueling lawsuits are a reflection of what several legal scholars predicted in a recent article: that the aftermath of the Supreme Court’s decision would be “a complicated world of novel interjurisdictional legal conflicts over abortion.” The authors — David S. Cohen, Greer Donley and Rachel Rebouché, all law professors — wrote that “instead of creating stability and certainty, it will lead to profound confusion because advocates on both sides of the abortion controversy will not stop at state borders in their efforts to apply their policies as broadly as possible.”
Recent articles by legal scholars and experts on drug and medical policy have made the case that the federal government has overarching authority to approve and regulate medications, a question only a few previous legal cases have tested.
These experts say states are allowed to adopt some laws and regulations that supplement federal rules on drugs and to regulate the practice of medicine within their jurisdiction. But they say states cannot impose policies that interfere with or contradict F.D.A. standards or requirements, so they cannot ban or drastically restrict a medication the federal government has approved.
“Under the U.S. Constitution, federal law preempts state law when the two clash,” Patricia Zettler, a law professor, and Ameet Sarpatwari, a professor of medicine, wrote in an article in The New England Journal of Medicine last year.
Scholars cite a 2014 Massachusetts case in which the state sought to ban a new opioid, Zohydro ER, because it worried that the drug could be abused and lead to addiction or overdose. A federal judge sided with the drug company, Zogenix. If the state “were able to countermand the F.D.A.’s determinations and substitute its own requirements, it would undermine the F.D.A.’s ability to make drugs available to promote and protect the public health,” the judge wrote. Subsequent efforts by Massachusetts to restrict Zohydro were also rejected by the courts.
Skye Perryman, a lawyer for GenBioPro and president of Democracy Forward, a center-left legal advocacy organization, said West Virginia’s ban was “an overreach of state authority when a state tries to step in the shoes of F.D.A. and to make safety and efficacy determinations that conflict with and interfere with F.D.A.’s judgments.”
West Virginia adopted an abortion ban in September. The suit contends that the ban violates the Constitution’s supremacy clause, which says that federal laws — in this case, Congress’s decision to authorize the F.D.A. to regulate drugs like mifepristone — have priority over conflicting state laws. The suit also says such bans violate the Constitution’s commerce clause, which prohibits states from impairing interstate commerce.
GenBioPro, which started making generic mifepristone in 2019, said in the suit that because of West Virginia’s ban and previously enacted abortion restrictions, it had been able to ship only 72 units of mifepristone to be used in the state and that by August 2022, its sales had dropped to zero there. GenBioPro said its sales had dropped to nothing in seven other states with abortion bans and in Wisconsin, where abortion services have stopped operating in light of unclear laws.
Dr. DeShawn Taylor, GenBioPro’s medical director, said that bans “deprive people of the ability to access safe and effective medications and it also jeopardizes our company.” She added, “If people don’t have access to mifepristone, then of course, it impacts the company’s bottom line.” Dr. Taylor, an obstetrician-gynecologist who owns a family planning clinic in Arizona, also noted that mifepristone is frequently used in treating patients who are experiencing miscarriages.
A notable aspect of the F.D.A.’s regulation of mifepristone is that for a dozen years, the agency has imposed an additional framework of restrictions and monitoring for the drug. Called a Risk Evaluation and Mitigation Strategy, or REMS, it has been used for only about 300 other drugs, only 60 of which are currently actively under the framework. In recent years, the F.D.A. has extensively reviewed new data on mifepristone and has lifted several of the restrictions, including the requirement that patients obtain the drug in person from a provider.
Some legal experts say the F.D.A.’s decision to apply special restrictions to mifepristone, and to gradually ease some of them as evidence of safety and efficacy has grown, strengthens the case for striking down state bans and restrictions and affirms that the federal government is the ultimate authority on the drug.
“A strong case can be made that state-required measures that go beyond the conditions” set by the F.D.A.’s restrictions on mifepristone “upset the complex balancing of safety and burdens on the health care system that federal law requires of the F.D.A.,” The New England Journal of Medicine article said.
The Texas case filed by opponents of abortion seeks to reverse more than 20 years of federal decisions about medication abortion, claiming that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000.
The case was filed by the Alliance for Hippocratic Medicine — an organization that lists five anti-abortion groups as its members — in Amarillo, Texas, where it was assigned to the only judge in the Northern District of Texas, Matthew Kacsmaryk. Before his appointment, Judge Kacsmaryk, a Trump appointee, wrote an article that was critical of Roe v. Wade, as well as issues like marriage equality and federal anti-discrimination protections for sexual orientation and gender identity.
Dr. Christina Francis, the chief executive officer of the American Association of Pro-Life Obstetricians and Gynecologists, a group that belongs to the alliance, said that the F.D.A., in its initial approval and its recent decisions to ease some restrictions on mifepristone, had “reviewed a handful of cherry-picked studies that don’t actually look at the full picture.” She added that agency officials were “actively endangering the lives of women and girls in the country, especially as they continue to remove safeguard after safeguard.”
Most medical organizations say that extensive data shows the opposite: that with mifepristone, the F.D.A. has been considerably more restrictive than necessary and that allowing it to be prescribed via telemedicine and received in the mail were changes that were long overdue.
Indeed, two citizen petitions opposing the F.D.A.’s actions on mifepristone, filed in 2002 and 2019 by some of the same anti-abortion organizations, were rejected by the agency as unfounded. And a 2008 review by the Government Accountability Office found no irregularities with the F.D.A.’s mifepristone approval.
Because of the scientific evidence and rigor of the F.D.A.’s handling of mifepristone, many experts on reproductive health law said they had initially viewed the Texas case as so baseless that it would have no chance at succeeding. But some are starting to worry.
“This should have been a fringe lawsuit, and it should have been tossed out very quickly,” said Jenny Ma, senior counsel for the Center for Reproductive Rights. But she said that now, supporters of abortion rights are worried that the case is before a judge whose writings and decisions reflect a resolutely conservative ideology.
“A single district court judge in Texas, which is a state that already has banned all abortion, could be issuing a nationwide ban on medication abortion, which now accounts for more than half of abortions in the United States, and obviously, the effects would be devastating,” Ms. Ma said.
Erik Baptist, senior counsel for the Alliance Defending Freedom, a conservative Christian legal advocacy group, which represents the plaintiffs, expressed confidence in the case. “A court will look at what the F.D.A. was legally required to do when evaluating the safety and effectiveness of a new drug — here, chemical abortion drugs — and it will probably take a different viewpoint than the F.D.A., in terms of reviewing the prior agency actions.”
In a response to the case filed this month, the F.D.A. called the case “unprecedented” and said that if the judge granted the plaintiffs’ request for an injunction that stopped access to mifepristone, it would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”