Who’s de­lay­ing gener­ic com­pe­ti­tion? FDA pub­lish­es a long list of drug­mak­ers they say gamed the sys­tem

Mak­ing good on the ad­min­is­tra­tion’s promise to name and shame drug­mak­ers  — most re­cent­ly re­it­er­at­ed in HHS Sec­re­tary Alex Azar’s speech Mon­day — the FDA has re­leased a list of them, all ac­cused of un­fair­ly with­hold­ing ref­er­ence sam­ples of their drugs in or­der to block gener­ic en­try.

On a list of 52 ref­er­ence list­ed drugs (RLDs) post­ed Thurs­day, the FDA de­tailed the names and de­vel­op­ers of each one, along­side the num­ber of ac­cess in­quiries the agency has re­ceived in re­la­tion to them. The pub­li­ca­tion of this list, which you can see be­low, is part of the FDA’s drug com­pe­ti­tion ac­tion plan as it com­mits to ad­dress and im­prove “trans­paren­cy about this and oth­er gam­ing tac­tics that de­lay the gener­ic com­pe­ti­tion Con­gress in­tend­ed.” With­out sam­ple drugs, gener­ic com­pa­nies can­not con­duct bioe­quiv­a­lence stud­ies — a fun­da­men­tal part of any AN­DA.

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