Courts Say Big Pharma is Breaking the Law | 340B Matters
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01 Dec Courts Say Big Pharma is Breaking the Law

By 340B Matters

Despite Big Pharma’s efforts to eviscerate the 340B Drug Discount Program, recent federal court decisions have made it clear that manufacturers are acting illegally. Eli Lilly, along with eight other huge drug makers, have unilaterally limited required drug discounts to safety-net health care providers.The legal fights are far from over, however, and several rulings offer some contradictory opinions on manufacturer complaints about the program.

On October 29, a federal court in Indiana ruled that drug companies are not allowed to deny 340B pricing to hospitals that contract with local pharmacies. “The statute, correctly construed, does not permit drug manufacturers, such as Lilly, to impose unilateral extra-statutory restrictions on its offer to sell 340B drugs to covered entities utilizing multiple contract pharmacy arrangements,” wrote US District Judge Sarah Evans Barker.

For this reason, Judge Barker said a May enforcement letter that the Health Resources & Services Administration sent Lilly ordering it to restore discounts on drugs dispensed at community pharmacies was within the agency’s authority under the 340B law.

A separate ruling November 5 by the United States District Court of New Jersey came to the same conclusion: “More specifically, as to the Violation Letters, I uphold [the Department of Health and Human Services’] assessment that Plaintiffs cannot unilaterally impose restrictions on offers to covered entities and that their policies must cease,” wrote US Chief District Judge Freda Wolfson. The judge also denied efforts by Sanofi-Adventis and Novo Nordisk to challenge HRSA’s Administrative Dispute Resolution system.

These federal courts have affirmed what we’ve known all along: The cabal attacking the 340B program is losing the argument that they are not required to provide discounts to covered health providers using community pharmacies. These local partners are an essential part of America’s healthcare safety-net because they allow medicines to be dispensed closer to patients and expand access to life-saving drugs.

Given the decisions reached in these cases, it’s time for these outlier drug companies to abandon their foolhardy and illegal activities and to get right with the law.



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