By Shira Stein
August 9, 2022
Attorneys disagreed over whether Congress gave enough guidance on which drugs should be negotiated so as to prevent litigation over the issue.
“There are many ways in which this proposal is extremely specific, and some of them are designed to provide as much guidance to HHS as possible,” Sachs said, such as how and when the federal government should negotiate, which drugs are eligible, and factors to consider.
Congress “provided a lot of structure, both procedural and substantive, in how that negotiation process ought to be created,” Sachs said.
But Gostin said it could be that the guidance from Congress was too vague and that “the danger is that some courts might think the administration overreached, and that they didn’t have a clear enough signal for Congress.”
“Within both the negotiation and the inflation penalty sections, they put in specific clauses saying that some of these determinations are not subject to judicial review. So that really forecloses some litigation opportunities there,” said Sean Dickson, director of health policy at the research organization West Health Policy Center.
There could also be litigation around whether Congress can even control and set drug prices, Gostin said.
“One might argue that Congress doesn’t have the power to delegate such sweeping authority and discretion to a federal agency,” Gostin said. “That’s another potential weakness. But at least until now, the non-delegation doctrine hasn’t gotten a lot of traction.”