Novartis Pharmaceuticals Corporation v. Robert F. Kennedy, Secretary of Health and Human Services, et al.

The Drug Price Negotiation Program (Program) threatens enterprise-destroying fines unless a drug manufacturer both provides its products at government-dictated prices and publicly declares that those coerced prices are “fair.” The fines at the root of the law are unprecedented in scope—for petitioner Novartis, they would swiftly escalate to $93.1 billion annually. The Third Circuit declined even to address whether this extraordinary penalty was excessive under the Eighth Amendment, because it found that the Anti-Injunction Act (AIA) divests federal court jurisdiction over any challenge to a civil penalty unconnected to criminal conduct so long as Congress labels it a tax. The court then concluded that the coerced transfers did not reflect an unconstitutional taking because they were “voluntary,” and that the compelled speech at issue did not implicate the First Amendment because it was merely “incidental” to the regulation of conduct. Each holding involves constitutional questions of first-order importance. The questions presented are:

1. Whether the AIA bars review of any challenge under the Excessive Fines Clause of a civil penalty unconnected to criminal conduct whenever Congress labels it a tax, even when it is effectively unpayable.

2. Whether the Program violates the Fifth Amendment by forcing manufacturers to transfer drugs to third parties at government-dictated prices.

3. Whether the Program violates the First Amendment by coercing manufacturers into expressing the government’s preferred viewpoints on matters of public concern with which the manufacturers disagree.