office worker holding a stack of papers
Multiple briefs have been filed recently in federal appellate lawsuits over the government's enforcement ability with the 340B contract pharmacy program.

A Blizzard in July (of Briefs in 340B Contract Pharmacy Lawsuits)

There’s been a burst of activity in federal appellate lawsuits over the legality of drug manufacturers’ conditions on 340B pricing involving contract pharmacies.

During the past two weeks, AstraZeneca, Lilly, Novo Nordisk, and Sanofi filed briefs restating their belief that the federal government can’t force them under pain of fines or expulsion from Medicaid and Medicare to offer 340B pricing when entities buy covered outpatient drugs and ship them to outside pharmacies to be dispensed.

Just yesterday, the government filed a brief in Novartis and United Therapeutics’ consolidated cases restating that federal law does not let manufacturers restrict covered entities’ use of contract pharmacies.

Ruling Are Getting Closer

None of the briefs appears to have broken new legal ground. The filings, however, are a sign that the four lawsuits—AstraZeneca’s, Lilly’s, Novo Nordisk and Sanofi’s consolidated cases, and Novartis and UT’s consolidated cases—are getting closer to oral arguments and decisions.

AstraZeneca’s case and Novo Nordisk and Sanofi’s consolidated cases are all before the federal appeals court in Philadelphia. They probably will be folded together for argument and decision. Lilly’s case is being heard in Chicago and Novartis and UT’s consolidated cases in Washington, D.C. That means there likely will be three appeals court decisions on 340B contract pharmacy, maybe with one or more decision by the end of this year.

The likelihood of the U.S. Supreme Court agreeing to decide a matter increases if there is a split among federal circuit courts over what the law requires.

If the three appeals courts hand down divergent decisions in 2022 or 2023, and the Supreme Court accepts a petition to get involved, arguments probably would not be scheduled any sooner than October 2023. An opinion probably would not be delivered unit the first half of 2024.

Links to Recently Filed Briefs

AstraZeneca’s July 21 brief

Lilly’s July 25 brief

Novo Nordisk’s two July 20 briefs

Sanofi’s two July 14 briefs

The federal government’s July 27 brief in Novartis and UT’s consolidated cases

Editor at Large | Website | + posts
« Read Previous Read Next »
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors

*Sign up for news summaries and alerts from 340B Report