West Virginia can restrict abortion pill sales, judge rules, despite FDA approval that it's safe

CHARLESTON, W.Va. — West Virginia can restrict the sale of the abortion pill, despite federal regulators' approval of it as a safe and effective medication, a federal judge has ruled.

U.S. District Court Judge Robert C. Chambers determined Thursday that the near-total abortion ban signed by Republican Gov. Jim Justice in September 2022 takes precedence over approvals from the U.S. Food and Drug Administration.

“The Supreme Court has made it clear that regulating abortion is a matter of health and safety upon which States may appropriately exercise their police power,” Chambers wrote in a decision dismissing most challenges brought against the state by abortion pill manufacturer GenBioPro, Inc. in a January lawsuit filed in the state southern district’s Huntington division.

Since the U.S. Supreme Court last year overturned Roe v. Wade, the 1973 ruling that provided nationwide access to abortion, most GOP-controlled states have enacted or adopted abortion bans of some kind, restricting abortion pills by default. All have been challenged in court.

Legal experts foresee years of court battles over access to the pills, as abortion-rights proponents bring test cases to challenge state restrictions.

In West Virginia's case, regulation of medical professionals “is arguably a field in which the states have an even stronger interest and history of exercising authority,” than the federal government, Chambers decided.

GenBioPro, Inc., the country’s only manufacturer of a generic version of the abortion pill mifepristone, had argued that the state cannot block access to a U.S. Food and Drug Administration-approved drug.

Chambers dismissed the majority of the manufacturer's challenges, finding there is “no disputing that health, medicine, and medical licensure are traditional areas of state authority.”

In a statement Friday, GenBioPro CEO Evan Masingill said the company remains “confident in the legal strength” of its case and is considering next steps.

“GenBioPro was founded on the belief that all people should have access to evidence-based, essential medication and will continue to use all legal and regulatory tools available to ensure access for all,” he said.

The decision was lauded by West Virginia Republican Attorney General Patrick Morrisey.

“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,” he said in a statement. “I will always stand strong for the life of the unborn.”

Chambers will allow a challenge by the manufacturer concerning telehealth to proceed, however. Congress has given the FDA the right to dictate the manner in which medications can be prescribed, and the agency has determined that mifepristone can be prescribed via telemedicine.

Morrisey said his office looks forward to arguing the telehealth issue: “We are confident in the merits of our case.”

Mail-order access to the drug used in the most common form of abortion in the U.S. would end under a federal appeals court ruling issued Aug. 16 that cannot take effect until the Supreme Court weighs in.

The decision by three judges on the 5th U.S. Circuit Court of Appeals in New Orleans overturned part of a lower court ruling that would have revoked the Food and Drug Administration’s 23-year-old approval of mifepristone. But it left intact part of the ruling that would end the availability of the drug by mail, allow it to be used through only the seventh week of pregnancy rather than the 10th, and require that it be administered in the presence of a physician.

Those restrictions won’t take effect right away because the Supreme Court previously intervened to keep the drug available during the legal fight.

The panel’s ruling would reverse changes the FDA made in 2016 and 2021 that eased some conditions for administering the drug.

President Joe Biden’s administration said it would appeal, with Vice President Kamala Harris decrying the potential effect on abortion rights, as well as on the availability of other medications.

“It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA,” Harris’ statement said.

Abortion rights advocates said the ruling poses a major threat to abortion availability following last year’s Supreme Court ruling that overturned Roe v. Wade and the nationwide right to abortion.

There is virtually no precedent for a U.S. court overturning the approval of a drug that the FDA has deemed safe and effective. While new drug safety issues often emerge after FDA approval, the agency is required to monitor medicines on the market, evaluate emerging issues and take action to protect U.S. patients. Congress delegated that responsibility to the FDA — not the courts— more than a century ago.

Mifepristone is one of two pills used in medication abortions. The other drug, misoprostol, is also used to treat other medical conditions. Health care providers have said they could switch to misoprostol if mifepristone is no longer available or is too hard to obtain. Misoprostol is somewhat less effective in ending pregnancies.