Got­tlieb: 'End the shenani­gan­s' on slow-play­ing REMS to de­lay gener­ic drug com­pe­ti­tion

FDA com­mis­sion­er Scott Got­tlieb yes­ter­day called on brand name drug com­pa­nies to “end the shenani­gans” that re­strict gener­ic drug com­pe­ti­tion, specif­i­cal­ly point­ing to the tac­tic of slow-play­ing shared Risk Eval­u­a­tion and Mit­i­ga­tion Strate­gies (REMS) terms in­tend­ed to pre­vent gener­ic man­u­fac­tur­ers from pur­chas­ing drug prod­ucts need­ed to run bioe­quiv­a­lence or bioavail­abil­i­ty stud­ies that FDA ap­proval re­quires.

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