Un­der ‘threat’ of fines, No­var­tis sues HHS over drug pric­ing pro­gram

The bio­phar­ma in­dus­try is not tak­ing the threat of even mod­est civ­il mon­e­tary penal­ties light­ly, as No­var­tis last week sued the Biden ad­min­is­tra­tion’s HHS over plans to as­sess such penal­ties for changes that the com­pa­nies made in re­gard to a small but high-pro­file drug dis­count pro­gram for hos­pi­tals.

Un­der the pro­gram, known as 340B and run by HHS’ Health Re­sources and Ser­vices Ad­min­is­tra­tion, drug­mak­ers are re­quired by law to sell their prod­ucts at heav­i­ly dis­count­ed prices so hos­pi­tals can pro­vide them to low-in­come pa­tients. Al­though the na­tion­al pro­gram is some­where be­tween 8% and 5% of the en­tire US drug mar­ket, bio­phar­ma com­pa­nies have crit­i­cized the bal­loon­ing growth of cer­tain con­tract phar­ma­cies that are now op­er­at­ing on be­half of many of the hos­pi­tals and took ac­tion to halt that growth over the past year.

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