US argues that AstraZeneca’s IRA suit ‘fares no better than the others’

The De­part­ment of Jus­tice on Wednes­day took a crack at dis­man­tling As­traZeneca’s law­suit over the se­lec­tion of its type 2 di­a­betes drug Farx­i­ga (da­pagliflozin) for drug price ne­go­ti­a­tions, say­ing it “fares no bet­ter than the oth­ers.”

As­traZeneca, which filed its com­plaint in Delaware fed­er­al court in Au­gust, con­test­ed two as­pects of CMS’ guid­ance ex­plain­ing how it planned to se­lect which drugs would be in­clud­ed in the first year of ne­go­ti­a­tions. The British com­pa­ny took is­sue with the way that CMS de­fines “qual­i­fy­ing sin­gle source drug,” with the drug­mak­er say­ing it should en­com­pass “on­ly one NDA or BLA.” It al­so took is­sue with the way CMS de­fined com­pe­ti­tion, say­ing gener­ics don’t need to be mar­ket­ed in a “bona fide” man­ner.

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