West Virginia sued for its ban of abortion pill

Case’s outcome expected to affect other states’ laws

A patient gets the first of two pills taken for a medical abortion during a visit Oct. 22 to a Planned Parenthood clinic in Kansas City, Kan.
(AP/Charlie Riedel)
A patient gets the first of two pills taken for a medical abortion during a visit Oct. 22 to a Planned Parenthood clinic in Kansas City, Kan. (AP/Charlie Riedel)

A company that makes an abortion pill filed a lawsuit Wednesday morning challenging the constitutionality of a state ban on the medication, one 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 U.S. 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-19 vaccines or morning-after pills.

The FDA approved mifepristone in 2000 to end pregnancy, when used in combination with a second drug, misoprostol. The combination is approved for use up to the 10th week of pregnancy.

For more than 20 years, FDA limited dispensing of the drug to a subset of specialty offices and clinics because of safety concerns. In rare cases, the drug combination can cause excess bleeding, requiring emergency care. But since the start of the covid-19 pandemic, the agency has repeatedly eased restrictions and expanded access, increasing demand even as state laws make the pills harder to get for many women.

In late 2021, the agency eliminated the in-person requirement for the pill, saying a new scientific review showed no increase in safety complications if the drug is taken at home. That change also permitted the pill to be prescribed via telehealth and shipped by mail-order pharmacies.

Earlier this year the FDA further loosened restrictions by allowing brick-and-mortar pharmacies to dispense the drug, provided they undergo certification.

That change was made at the request of the two drug manufactures: GenBioPro and Danco Laboratories, which makes brand-name Mifeprex.

ONE SUIT OF MANY

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. Also on Wednesday, an obstetrician-gynecologist sued officials in North Carolina, which still allows abortion, challenging the state's requirements for using mifepristone because they go beyond FDA regulations on the drug. In November, opponents of abortion filed a lawsuit challenging the FDA's approval of mifepristone and asked that the courts order the agency to stop allowing the use of the drug and 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 the U.S., and with recent FDA 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 Rebouche, 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 FDA 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 FDA's determinations and substitute its own requirements, it would undermine the FDA'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 FDA and to make safety and efficacy determinations that conflict with and interfere with FDA'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' decision to authorize the FDA 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.

In a statement Wednesday, West Virginia's attorney general, Patrick Morrisey, said: "We are prepared to defend West Virginia's new abortion law to the fullest. While it may not sit well with manufacturers of abortion drugs, the U.S. Supreme Court has made it clear that regulating abortion is a state issue."

COMPANY HIT

GenBioPro, which started making generic mifepristone in 2019, said 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." 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 FDA'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 FDA 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 FDA's decisions 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 FDA's restrictions on mifepristone "upset the complex balancing of safety and burdens on the health care system that federal law requires of the FDA," the New England Journal of Medicine article said.

The North Carolina lawsuit was filed by Dr. Amy Bryant, an abortion provider at the University of North Carolina. North Carolina's restrictions include a requirement that mifepristone be taken in the presence of a physician, who must first provide state-mandated counseling to the patient and then wait 72 hours before administering the medication, said Eva Temkin, a lawyer representing Bryant in the case.

"Ultimately, FDA has expressly concluded that requirements like the ones that are imposed by North Carolina are not necessary to ensure patient safety and are contrary to FDA regulatory balancing," said Temkin, who until recently was a lawyer for the FDA.

A spokesperson for North Carolina's attorney general, Josh Stein, said the office was reviewing the case.

Bryant brought a lawsuit in 2016 with several other OB-GYNs that challenged North Carolina's 20-week abortion ban. A federal court deemed the ban unconstitutional in 2019, a ruling that was reversed when the U.S. Supreme Court overturned Roe v. Wade.

This case centers around mifepristone. For the past several years, the Food and Drug Administration has slowly peeled away restrictions on the medication -- allowing health care providers other than doctors to prescribe the medication and retail pharmacies to dispense it.

However, North Carolina state laws place heavier restrictions on the pill, allowing doctors to provide the pill only in person at certified facilities, and after a 72-hour waiting period.

North Carolina's restrictions, the lawsuit argues, impose significant costs and burdens on Bryant and her patients and prevent her from providing care according to her best medical judgment.

Bryant's lawsuit asks the Federal District Court to confront the differences between state and federal law and consider whether North Carolina's laws on the pill are an overstep, as the plaintiff argues.

A Texas case filed by opponents of abortion seeks to reverse more than 20 years of federal decisions about medication abortion, claiming that the FDA 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 judge in the Northern District of Texas who covers Amarillo, Matthew Kacsmaryk. Before his appointment, Kacsmaryk, a Trump appointee, wrote an article that was critical of Roe v. Wade, as well as issues such as marriage equality and federal anti-discrimination protections for sexual orientation and gender identity.

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 FDA 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 FDA, in terms of reviewing the prior agency actions."

In a response to the case filed this month, the FDA 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."

Information for this article was contributed by Pam Belluck of The New York Times; by Matthew Perrone, Gary Robertson and Leah Willingham of The Associated Press; and by Teddy Rosenbluth of The Charlotte Observer (TNS).


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