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