Delia Deschaine Discusses Mifepristone Lawsuit and FDA Regulations for Dispensing and Prescribing

An ongoing lawsuit over Mississippi’s abortion pill restrictions could set a roadmap for the Biden administration and others seeking to ease access to the medication across the country as the US Supreme Court considers overturning Roe v. Wade.
GenBioPro, the manufacturer of generic mifepristone, contends the FDA’s regulations for dispensing and prescribing the pill preempt the state’s stricter requirements, including that a licensed physician prescribe it in person. Constitutional and FDA policy attorneys say that argument may have legs and could serve as a basis for any future lawsuits against state mifepristone restrictions.
“Courts have routinely granted deference to FDA” over states when determining under what conditions a drug can be used safely and effectively, said Delia Deschaine, an attorney at Epstein Becker & Green specializing in FDA regulations.
Mifepristone has gained focus as the administration and reproductive health advocacy groups brace for a potential high court decision overturning the landmark ruling that legalized abortion nationwide. FDA regulation of the pill wouldn’t change if Roe is overturned, but some legal battles could arise over states’ authority to put rules in place that go beyond those recommended by the federal agency.
A hearing is set for June 8 to consider Mississippi State Health Officer Thomas Dobbs’s motion to dismiss the GenBioPro case. …
Making the Case
The Zogenix case “stands for the position that a state law that significantly impedes access to an FDA-approved drug product is preempted by federal law,” Deschaine said. …
States’ Defense
Deschaine argued that because these two previous cases don’t explicitly deal with an FDA-approved drug, or the issue of abortion, there “are distinguishing factors that may impact the strength” of a state’s argument.