I can fairly be faulted for giving too much attention to bad judicial rulings and not enough attention to excellent ones. In an effort to remedy that fault, I am pleased to highlight Fourth Circuit judge J. Harvie Wilkinson’s outstanding opinion (in GenBioPro, Inc. v. Raynes) holding that the FDA’s approval of mifepristone does not preempt West Virginia’s law against abortion as that law applies to mifepristone-induced abortions.

To be sure, the bottom-line conclusion is so obvious that it’s difficult to see how anyone could think otherwise (though dissenting Biden appointee DeAndrea Gist Benjamin somehow manages to). But Wilkinson does the valuable work of systematically demolishing the preemption argument.

Here’s an excerpt (citations omitted; cleaned up):

The [FDA’s] task has always been to “ensure that drugs on the market are safe and effective.” It has never been authorized to “regulate the practice of medicine” or mandate that specific drugs be available. To read an access mandate into the FDAAA would be to radically redefine the FDA’s historic role and authorize an unprecedented federal intrusion into the regulation of medical practice—an area long reserved to the states….
It is also worth pausing to reflect on the sheer breadth of GenBioPro’s position. The FDA has imposed a REMS on a wide array of potent drugs, including highly dangerous opioids such as fentanyl. Under GenBioPro’s interpretation, the FDAAA would preempt any state law restricting access to those drugs. State governments would be powerless, for example, to limit prescriptions of addictive opioids or even enforce their bans on physician-assisted suicide against doctors seeking to prescribe lethal drugs regulated under a REMS. And according to GenBioPro, Congress brought about this dramatic result by alluding to “drug access” in the title of a subsection and instructing the FDA to ensure that its own restrictions do not unduly burden access.
We think Congress would have spoken with a much clearer voice if it intended to effect such a radical change in the federal-state balance. In our view, the statute means exactly what it says—the FDA can impose safe-use restrictions on high-risk drugs, and those restrictions cannot unduly burden access to the drug. But that does not cut the states out of the picture. We do not dispute that, as it does with all laws, Congress sought to “strike a balance” between competing interests when it enacted the FDAAA. But courts are confined to enforcing the balance that is reflected in the text of the statute. We are not permitted to undertake a “freewheeling judicial inquiry” into an alternative balance that Congress may have hidden between the lines. The text here limits the FDA but not the states from restricting access to REMS drugs. We are therefore left with the unmistakable conclusion that “[p]art of that balance” Congress struck “involved allocating authority between the Federal Government and the States.”

A sanity test for the liberals who dominate the Fourth Circuit will be whether they decline to grant rehearing en banc. I’m not confident that they will pass this sanity test. But if they don’t, I agree with Judge Wilkinson that a contrary ruling “invites certain reversal” by the Supreme Court.

Congrats to Erin Hawley and the Alliance Defending Freedom on this victory!