Three judges for the U.S. Court of Appeals for the Washington, D.C. Circuit ruled May 21 in favor of drug manufacturers' ability to limit sales and distribution of discounted drugs in the government's 340B drug pricing program.
The panel of judges reaffirmed a previous ruling that agreed that drug manufacturers are not in violation of the 340B rules when they decide to limit distribution through their respective contracts, Courthouse News Service reported.
The judges wrote in their decision that 340B "does not categorically prohibit manufacturers from imposing conditions on the distribution of covered drugs to covered entities. We further hold that the conditions at issue here do not violate Section 340B on their face."
"We respectfully disagree with the D.C. Circuit’s decision," Maureen Testoni, CEO of the nonprofit 340B Health, shared with Becker's. "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."
The 340B drug pricing program has been in place since 1992 to allow qualifying hospitals and clinics that treat low-income and uninsured patients to purchase certain drugs at a discounted rate between 25% and 50%.
Several manufacturers, 25 to be exact, now impose some type of 340B restrictions. According to 340B Health, the comprehensive list of drugmakers that now impose some type of restrictions for 340B participants includes: AbbVie, Amgen, Astellas, AstraZeneca, Bausch Health, Bayer, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, Exelixis, Gilead, GlaxoSmithKline, Jazz Pharmaceuticals, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Organon, Pfizer, Sanofi, Teva, UCB and United Therapeutics.
Hospitals have pushed back on the restrictions claiming "reducing access to the 340B Drug Pricing Program would directly impact hospitals' ability to offer a wide range of health care services to some of the nation's most vulnerable populations," as the American Hospital Association wrote in an Aug. 22 letter to a House committee.
However, drugmakers have stated that their policies seek "to maintain access for patients and adhere to the intent of the 340B program to provide discounted pricing on outpatient medicines to qualifying organizations" a Jazz Pharmaceuticals spokesperson told Becker's in a previous statement following its September 2023 announcement of some restrictions.