STATEMENT ON D.C. CIRCUIT APPEALS COURT DECISION ON DRUG COMPANIES’ 340B RESTRICTIONS
WASHINGTON, D.C.— Yesterday, the U.S. Court of Appeals for the District of Columbia Circuit issued a decision largely in favor of two drug companies that have imposed harmful limits on safety-net hospitals’ access to 340B drug pricing program discounts. The three-judge panel concluded that Novartis and United Therapeutics policies restricting access to discounted drugs through community and specialty pharmacy partnerships do not violate the 340B statute on its face. However, the judges acknowledged that the Novartis and United Therapeutics policies could violate the statute as applied in particular circumstances and that other, more onerous drug company restrictions could violate the law.
The following statement is attributed to 340B Health President and CEO Maureen Testoni:
“We respectfully disagree with the D.C. Circuit’s decision. We are disappointed the court found that the 340B statute does not categorically prohibit manufacturers from imposing conditions. However, we are encouraged that the court made clear that conditions violate the 340B statute if, for example, they effectively raise the 340B price or essentially bar access to 340B for a particular provider.”
“Unilateral drug company restrictions have siphoned billions of dollars away from providers and into drugmakers’ pockets at the expense of at-risk patients and underserved communities who rely on 340B the most. It's important to recognize that 340B hospitals provide 77% of hospital care to Medicaid patients and 67% of the nation’s unpaid hospital care, making it an indispensable resource for America’s most vulnerable patients and the entire health care safety net. As we await the Chicago appellate court decision, we remain steadfast in our advocacy for the protection of 340B and urge the Biden administration to vigorously defend the law.”
“Federal lawmakers are considering a bill named the 340B PATIENTS Act. It would clarify that the 340B statute requires participating drug companies to provide discounted drugs to covered entities through community and specialty pharmacies, and it would prohibit drugmakers from placing additional barriers on access to 340B pricing. Lawmakers must protect 340B.”
Contact: Jon Tilton at jon.tilton@340bhealth.org or 202-536-2285