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.

The re­marks came at an Fed­er­al Trade Com­mis­sion pan­el on pre­scrip­tion drug com­pe­ti­tion and co­in­cid­ed with new FDA draft guid­ance de­signed to curb the de­lay tac­tic, mak­ing it eas­i­er to im­ple­ment a share a sin­gle shared REMS.

“Cur­rent­ly, un­der a shared sys­tem REMS, mul­ti­ple ap­pli­cants need to co­or­di­nate the sub­mis­sion of iden­ti­cal REMS-re­lat­ed doc­u­ments for their re­spec­tive ap­pli­ca­tions. This draft guid­ance ex­plains the FDA’s cur­rent think­ing that the use of a sin­gle Drug Mas­ter File (DMF) for shared sys­tem REMS sub­mis­sions will al­low man­u­fac­tur­ers with prod­ucts in shared sys­tem REMS pro­grams to sub­mit one col­lec­tive set of files to the agency. This is a first step to­ward ad­di­tion­al ac­tions FDA plans to take to mak­ing shar­ing a sin­gle REMS eas­i­er,” Got­tlieb said.

He not­ed that he hopes this new REMS doc­u­ment tem­plate will stream­line the draft­ing and re­view of shared REMS.

Pan­el Dis­cus­sion

Sev­er­al speak­ers fol­low­ing Got­tlieb echoed his con­cerns on com­pa­nies gam­ing the sys­tem to main­tain mo­nop­o­lies that keep drug prices high.

Rut­gers law pro­fes­sor Michael Car­ri­er dis­cussed pay-for-de­lay agree­ments — where com­pa­nies are paid to keep their com­peti­tor gener­ics from the mar­ket; prod­uct hop­ping where prod­ucts are re­for­mu­lat­ed and pa­tients are mi­grat­ed to a new prod­uct be­fore com­peti­tors are mar­ket­ed; cit­i­zen pe­ti­tions — which are meant to raise le­git­i­mate con­cerns about fol­low-on prod­ucts, but of­ten come near the end of the prod­uct’s ex­clu­siv­i­ty (though 98% are de­nied by FDA); and the REMS re­stric­tions Got­tlieb men­tioned.

As­so­ci­ate pro­fes­sor of med­i­cine at Har­vard Med­ical School Aaron Kessel­heim al­so dis­cussed oth­er fac­tors im­pact­ing gener­ic drug up­take, in­clud­ing ad­ver­tis­ing and pro­mo­tions for brand­ed prod­ucts, pa­tient and physi­cian skep­ti­cism of the qual­i­ty of gener­ic drugs, cost and avail­abil­i­ty is­sues, and oth­er hur­dles to pre­vent com­pe­ti­tion, such as patents cov­er­ing sec­ondary parts of phar­ma­ceu­ti­cals.

Stephen Schon­delmey­er, pro­fes­sor and head of the de­part­ment of phar­ma­ceu­ti­cal care and health sys­tems at the Uni­ver­si­ty of Min­neso­ta, men­tioned that ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) con­tracts can lim­it or ma­nip­u­late com­pe­ti­tion and need to be ex­am­ined fur­ther. He of­fered the ex­am­ple of the atenolol short­age as a case where it’s un­clear what the cause of the short­age is.

Chip Davis, pres­i­dent of the gener­ic drug lob­by­ing group AAM, al­so ex­plained how gener­ic drug com­pa­nies are con­sol­i­dat­ing as there are es­sen­tial­ly three large pur­chas­ing con­sor­tia con­trol­ling 90% of the mar­ket.

“Let me be clear: Our mem­bers are not the on­ly ones rais­ing sus­tain­abil­i­ty con­cerns. Pur­chasers are re­in­forc­ing these de­fla­tion­ary trends too,” Davis said. “Sim­ple eco­nom­ics dic­tates that you won’t have 10 to 20 gener­ic com­pa­nies sup­port­ing three buy­ers.”

In terms of so­lu­tions, Kessel­heim was the on­ly pan­elist to call on FDA to con­sid­er a pol­i­cy where­by gener­ic drugs could be im­port­ed more sys­tem­at­i­cal­ly to en­large the US mar­ket. He al­so raised the pos­si­bil­i­ty that for cer­tain niche mar­kets, the US gov­ern­ment could of­fer pur­chas­ing con­tracts to al­low for guar­an­teed de­mand, which is al­ready done with chil­dren’s vac­cines.

Bern­stein se­nior an­a­lyst Ron­ny Gal al­so urged the FTC to put out its think­ing on phar­ma­ceu­ti­cal com­pa­ny-ne­go­ti­at­ed con­tracts with phar­ma­cy ben­e­fit man­agers, as sev­er­al such cas­es will be de­cid­ed over the next 24 months.

Oth­er pan­els on Wednes­day dis­cussed the role of PBMs and group pur­chas­ing or­ga­ni­za­tions in the sup­ply chain, as well as steps to en­cour­age en­try and ex­pand ac­cess through low­er prices.


Im­age: Scott Got­tlieb AP Im­ages


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

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