Novo Nordisk Inc., et al. v. Robert F. Kennedy, Secretary of Health and Human Services, et al.

The Inflation Reduction Act grants the Centers for Medicare and Medicaid Services (“CMS”) unprecedented and unfettered authority to impose price controls on pharmaceutical products. As interpreted by the government, the statute includes no enforceable standards or procedures to guide and constrain CMS’s price-setting decisions; authorizes the agency to implement price controls by imposing new binding rules at whim, unconstrained by the Administrative Procedure Act’s procedural and judicial review requirements; and forces manufacturers to express the view that any price CMS dictates is the “maximum fair price.” Although the statute levels an enterprise-crippling penalty on any manufacturer that does not comply, CMS claims that no constitutional constraints apply because the agency says it will not enforce the statute’s multi-billiondollar penalties if a manufacturer stops selling all of its products to the more than 140 million individuals who participate in Medicare and Medicaid. The questions presented are:

1. Is the separation of powers violated when an agency exercises sweeping price-setting and rulemaking authority with no constraints to ensure that it acts reasonably and within lawful bounds?

2. Is the federal government permitted to sidestep all constitutional constraints in the course of dictating the price of pharmaceutical sales made to a huge segment of the American population when such pricing is dictated in connection with a governmentfunded financial-assistance program, like Medicare?