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.
The US district court judge, Robert C Chambers, determined on Thursday that the near-total abortion ban signed by the Republican governor, Jim Justice, in September 2022 takes precedence over approvals from the US Food and Drug Administration (FDA).
“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 by the abortion pill manufacturer GenBioPro in a January lawsuit filed in the southern district’s Huntington division.
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 said.
GenBioPro, the only US manufacturer of a generic version of the abortion pill mifepristone, argued that the state cannot block access to an FDA-approved drug.
Chambers dismissed the majority of the manufacturer’s challenges, finding there was “no disputing that health, medicine and medical licensure are traditional areas of state authority”.
The Republican attorney general of West Virginia, Patrick Morrisey, said: “While it may not sit well with manufacturers of abortion drugs, the US supreme court has made it clear that regulating abortion is a state issue. I will always stand strong for the life of the unborn.”
Chambers allowed 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. The agency has determined that mifepristone can be prescribed via telemedicine.
Morrisey said his office looked forward to arguing the telehealth issue, “confident in the merits of our case”.
Mail-order access to the drug used in the most common form of abortion in the US would end under a federal appeals court ruling issued on 16 August that cannot take effect until the US supreme court weighs in.
The decision by three judges on the fifth US circuit court of appeals in New Orleans overturned part of a lower-court ruling that would have revoked a 23-year-old FDA 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 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.
The panel’s ruling would reverse changes the FDA made in 2016 and 2021 that eased some conditions for administering the drug.
Joe Biden’s administration said it would appeal, with Kamala Harris decrying the potential effect on abortion rights and 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,” the vice-president said.
Abortion rights advocates said the ruling poses a major threat to abortion availability following the 2022 supreme court ruling that overturned Roe v Wade and the nationwide right to abortion.
There is virtually no precedent for a US court overturning the approval of a drug 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 US 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. Healthcare 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.
English (US)