PhRMA calls doc­u­ment de­struc­tion part of new guid­ance on drug price ne­go­ti­a­tions 'un­con­sti­tu­tion­al'

Many have won­dered how the bio­phar­ma in­dus­try might take CMS to court over its new drug price ne­go­ti­a­tions plans, and lob­by­ing group PhRMA of­fered a hint with a new com­ment on the im­ple­men­ta­tion of the ne­go­ti­a­tion pro­vi­sions of the In­fla­tion Re­duc­tion Act.

The sec­tion of the guid­ance in ques­tion, known as Sec­tion 40.2.2, tells bio­phar­ma man­u­fac­tur­ers that CMS in­tends to re­quire that all in­fo re­ceived dur­ing the ne­go­ti­a­tion pe­ri­od from CMS “shall be de­stroyed with­in 30 days of a de­ter­mi­na­tion by CMS that the drug or bi­o­log­ic no longer qual­i­fies as a se­lect­ed drug, ex­cept as may be re­quired by ap­plic­a­ble state or fed­er­al law.”

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