Delia A. Deschaine, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Vox, in “What a Lawsuit in Mississippi Tells Us About the Future of Abortion Pills,” by Rachel M. Cohen.
Following is an excerpt:
As some states have moved to fully ban abortion in the wake of Dobbs v. Jackson Women’s Health, new questions emerged about abortion pills: Do states have the legal authority to outright ban drugs that have been approved by the U.S. Food and Drug Administration?
An ongoing federal lawsuit in Mississippi could provide a glimpse at the answer. GenBioPro, the manufacturer of generic abortion pills, is fighting to overturn state restrictions that impede access to the abortion pill mifepristone. Their lawsuit, filed in 2020, hinges on an argument that many legal experts expect other states and advocates to make in the coming months: that Mississippi’s restrictions on medication abortion are unduly excessive, illegally pre-empting the FDA’s authority on drug safety. …
Mississippi has urged for a dismissal of the case. Judge Henry Wingate, a Reagan appointee on the United States District Court for the Southern District of Mississippi, requested that both parties provide written submission on the impact, if any, of the Dobbs decision on the lawsuit, and on Mississippi’s “trigger law” banning abortions, which is set to take effect next week. Submissions are due on Thursday.
A ruling in favor of Mississippi could have implications for other jurisdictions seeking to ban abortion pills in a post-Roe landscape.
If upheld, it “would also open the floodgates for states to substitute their judgment for FDA’s in other controversial areas of medicine — some of which we may be aware of — some of which we may not be,” said Delia Deschaine, a DC-based attorney who specializes in FDA regulation. “For example, if there were a group of individuals opposed to palliative care, a state could conceivably limit access to medications that are approved for use in that context. This then becomes a situation where the practice of medicine using pharmaceuticals unpredictably varies between states — which creates its own host of public health issues.”
What it means to “pre-empt” the FDA
Through the passage of the Federal Food, Drug, and Cosmetic Actin 1938, Congress empowered the FDA as the sole agency to approve drugs in the US. It’s responsible for reviewing a drug’s safety, weighing its risks and benefits, and regulating appropriate conditions for safe and effective use. …
“The fact that this case relates to a medication that is used in abortion is one reason we might see the district court take a different stance than other courts on this issue,” said Deschaine. …
What’s next for the GenBioPro lawsuit …
In other words, if it is impossible to comply with both state and federal law at the same time, there remains a plausible preemption argument.
Deschaine, the attorney who specializes in FDA regulation, thinks upholding state restrictions on abortion pills could certainly affect whether other drug companies seek to go through the FDA approval process in the future.
“The incentives for developing FDA-approved drug products are strong, but those start to erode the more fractured the regulatory scheme for these products becomes,” she said. “If a company does not believe that it will be able to market its product in all US states/jurisdictions, then it may not be willing to assume the risk of pursuing the drug approval pathway. Indeed, even absent those restrictions, that pathway is very costly and uncertain.”
