Generic abortion drug manufacturer sues West Virginia over restrictions
One of the generic manufacturers of a drug used to end early pregnancies sued West Virginia’s attorney general today, claiming that federal law and the FDA’s regulations supersede West Virginia’s law banning the drug.
The case will likely be closely followed, given the fact that medication abortions are now the majority of all abortions, and as the Supreme Court last September revoked the right to abortion, paving the way for bans in almost all cases. And if West Virginia’s restrictions are overturned, as GenBioPro claims they “functionally displace FDA’s judgment in approving mifepristone and imposing a REMS,” this might be a test case for other states.
These lawsuits are super important bc they could restore access to medication abortion nationwide, even in states with bans. But they come against the backdrop of a lawsuit in TX trying to remove mife from the market nationwide, filed before a conservative ideologue judge.
— Greer Donley (@GreerDonley) January 25, 2023
But the suit notes that even before Roe v. Wade was overturned, West Virginia had restrictions around the use of mifepristone, including a waiting period requirement before obtaining it, and a prohibition on obtaining it via telemedicine.
“Federal law preempts West Virginia’s Ban and Restrictions,” the generic drug company GenBioPro wrote in its suit in West Virginia district court Wednesday. “These laws impermissibly restrict patients’ access to mifepristone and GenBioPro’s opportunity and ability to market, promote, and sell the medication in the State.”
The company also makes clear that Congress authorized the FDA, and only the FDA, to impose its restrictions on access to mifepristone.
“West Virginia cannot override FDA’s determinations about the appropriate restrictions on a medication that FDA approved for use and Congress subjected to this enhanced regulatory regime,” they added.
Earlier this month, the FDA announced that certain pharmacies could begin dispensing mifepristone. After conducting a “comprehensive review” of mifepristone’s risk evaluation and mitigation strategy (REMS) — which previously required patients to receive the drug in a clinic, medical office or hospital — the agency approved a modification that permits certified pharmacies to sell Danco Laboratories’ brand-name Mifeprex pills and the generic manufactured by GenBioPro.
GenBioPro’s suit also alleges that West Virginia law violates the Commerce Clause “by preventing providers from prescribing mifepristone via telemedicine,” meaning that patients are required to visit a healthcare professional in person to obtain a prescription.
Since 2019, when it first won approval for its generic mifepristone, GenBioPro said it has marketed and sold approximately 850,000 units of the drug.
Meanwhile, previous pharma companies have challenged state bans on certain drugs, like with the powerful opioid Zohydro in Massachusetts in 2014, and won in court.