Eli Lilly has moved to dismiss the complaint filed by Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital (“Tampa General”) in the U.S. District Court for the Middle District of Florida. The motion not only seeks dismissal with prejudice, but also presents an as-applied constitutional challenge to Florida’s Deceptive and Unfair Trade Practices Act (FDUTPA).
Lilly’s 340B Claims-Data Policy
At the center of this dispute is Lilly’s policy requiring 340B covered entities to submit claims-level dispensing data for Lilly products. The drugmaker introduced this policy in December 2021, at which time the requirement applied only to contract pharmacies. In January of 2026, Lilly extended the requirement to include drugs dispensed at covered entities’ own in-house pharmacies.
Lilly threatened to withhold 340B pricing on its drug products for any covered entity that refused to comply. Tampa General refused to submit the requested claims data and, consequently, lost access to 340B pricing on Lilly products. Tampa General responded by filing suit against Lilly in the U.S. District Court for the Middle District of Florida, alleging violations of FDUTPA, unfair methods of competition, and misrepresentation. Lilly subsequently moved to dismiss the complaint.
Lilly Invokes Astra and Federal Preemption
Among other things, Lilly contends that Tampa General’s suit is barred by Astra USA, Inc. v. Santa Clara County, 563 U.S. 110 (2011), in which the Supreme Court held that covered entities have no private right of action to enforce Section 340B “no matter the clothing in which [they] dress their claims.” 563 U.S. at 113-14. Lilly argues that every count in Tampa General’s complaint depends on an alleged violation of Section 340B and that the damages and injunctive relief requested are measured by the lost discount itself. Thus, according to Lilly, Tampa General’s claims must proceed through the established administrative dispute resolution (ADR) procedure administered by the Health Resources and Services Administration (HRSA).
Lilly also emphasizes preemption as another bar to Tampa General’s claims. In particular, Lilly asserts conflict preemption on the theory that allowing Tampa General’s state-law claims to proceed would disrupt the centralized enforcement scheme that Congress created under Section 340B.
It further asserts field preemption, arguing that Congress created a comprehensive federal framework for the 340B Program and left no room for states to regulate the issues raised by Tampa General’s claims.
Finally, Lilly argues that it enjoys intergovernmental immunity for acts related to the 340B Program because “Lilly is solely performing a federal function under its agreement with HHS—nothing more.” Lilly makes several other substantive arguments in support of its motion to dismiss Tampa General’s claims.
What the Tampa General Case Could Mean for 340B Covered Entities
This case is one of a growing number testing whether covered entities can challenge manufacturer restrictions and conditions through state consumer-protection and unfair-trade-practice statutes. Another pending lawsuit raising similar but distinct claims is Mosaic Health, Inc. v. Sanofi-Aventis U.S., LLC, where the Second Circuit held that Astra did not bar plaintiff’s federal antitrust claims alleging certain manufacturers conspired to limit the availability of 340B-discounted diabetes drugs.
No court has squarely addressed whether drugmakers like Lilly can restrict access to 340B pricing when a covered entity refuses to comply with the drugmaker’s claims-data policy. Whether manufacturers can impose such conditions unilaterally, and enforce compliance by restricting access to 340B pricing, remains a question ripe for judicial consideration.
How Frier Levitt Can Help
Frier Levitt regularly advises covered entities, contract pharmacies, and specialty pharmacy operators on 340B Program compliance, manufacturer policy changes, and the operational and contractual consequences of evolving 340B requirements. If your organization is navigating manufacturer claims-data requirements, restrictions on access to 340B pricing, or other 340B Program compliance and operational issues, contact Frier Levitt to discuss how these developments may affect your organization.
