FDA of­fers a pro­pos­al to help gener­ic drug de­vel­op­ers get si­mul­ta­ne­ous ap­provals in mul­ti­ple mar­kets

The FDA re­vealed Thurs­day that it’s of­fer­ing a pro­pos­al to the In­ter­na­tion­al Coun­cil on Har­mon­i­sa­tion — ICH — to bet­ter har­mo­nize sci­en­tif­ic and tech­ni­cal stan­dards for gener­ic drugs.

The plan is to let gener­ic drug de­vel­op­ers im­ple­ment a sin­gle glob­al drug de­vel­op­ment pro­gram, with com­mon el­e­ments of ap­pli­ca­tions to file, which will al­low for si­mul­ta­ne­ous ap­provals in mul­ti­ple mar­kets.

“This would make it eas­i­er for de­vel­op­ers that would oth­er­wise on­ly seek gener­ic drug ap­proval in one re­gion to al­so seek ap­proval in the Unit­ed States, in­creas­ing com­pe­ti­tion in Amer­i­ca. And it would al­so make it eas­i­er for de­vel­op­ers that would oth­er­wise on­ly seek gener­ic drug ap­proval in the US mar­ket to gain ac­cess to oth­er mar­kets,” FDA com­mis­sion­er Scott Got­tlieb said in a state­ment.

More specif­i­cal­ly, FDA is propos­ing that ICH de­vel­op a se­ries of guide­lines on stan­dards for demon­strat­ing bioe­quiv­a­lence for both non-com­plex and com­plex dosage forms, and drug prod­ucts. FDA ex­pects that ICH will re­view FDA’s pro­pos­al and that the ICH As­sem­bly will en­dorse the pro­pos­al at its next meet­ing in No­vem­ber 2018.

As far as ar­eas for po­ten­tial con­sid­er­a­tion, There­sa Mullin, as­so­ciate di­rec­tor for strate­gic ini­tia­tives at FDA, told at­ten­dees of the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines con­fer­ence in Sep­tem­ber, of the pos­si­bil­i­ties:

  • A se­ries of ICH guide­lines on bioe­quiv­a­lence stan­dards for sim­ple and com­plex dosage forms;
  • Asur­vey of ex­ist­ing ICH guide­lines for up­dat­ing as need­ed to in­cor­po­rate rec­om­men­da­tions for gener­ic drugs.

“These ac­tiv­i­ties in­clude pur­su­ing op­por­tu­ni­ties like a har­mo­nized bioe­quiv­a­lence study de­sign that could be ex­pand­ed to in­clude ad­di­tion­al study arms to ac­com­mo­date more than one ref­er­ence prod­uct for bridg­ing pur­pos­es,” Got­tlieb added.

Man­u­fac­tur­ing spec­i­fi­ca­tions may al­so dif­fer be­tween coun­tries.

“For ex­am­ple, right now a spe­cif­ic drug may need to be test­ed un­der dif­fer­ent dis­so­lu­tion meth­ods and ac­cep­tance cri­te­ria to sat­is­fy both the FDA and the Eu­ro­pean Med­i­cines Agency’s reg­u­la­to­ry re­quire­ments,” Got­tlieb said, not­ing that the lack of har­mo­niza­tion across ba­sic com­po­nents of gener­ic drug de­vel­op­ment re­duces the op­por­tu­ni­ties for gener­ic drug de­vel­op­ers to use their da­ta and in­for­ma­tion across mul­ti­ple ap­pli­ca­tions in dif­fer­ent ju­ris­dic­tions.

AAM said in a state­ment that it sup­ports FDA in this ini­tia­tive and looks for­ward to work­ing close­ly with them on it.

FDA al­so re­cent­ly con­duct­ed a pre­lim­i­nary analy­sis that found there are sig­nif­i­cant op­por­tu­ni­ties to ex­pand the avail­abil­i­ty and in­crease mar­ket com­pe­ti­tion for gener­ic drugs be­yond their cur­rent mar­kets.

In par­tic­u­lar, FDA ex­plored the ques­tion of whether there ap­pear to be op­por­tu­ni­ties for coun­tries to gain ac­cess to gener­ic drugs not cur­rent­ly avail­able. In ad­di­tion to the US mar­ket, FDA used da­ta avail­able from 2017 for a sam­pling of nine oth­er coun­tries in­clud­ing five in the EU (France, Ger­many, Greece, Poland and the UK), Japan, Cana­da, Switzer­land and Aus­tralia.

“First, FDA looked at whether the top 100 drugs dis­pensed in the U.S. were al­so avail­able in those nine oth­er coun­tries and found that all of the nine ex­pe­ri­enced some lack of avail­abil­i­ty of these drugs, which ranged from 5 (of 100) un­avail­able in Cana­da to 25 (of 100) un­avail­able in Japan,” Got­tlieb said.

“Next, FDA ex­am­ined the set of ap­prox­i­mate­ly 400 gener­ic drugs with the low­est vol­umes sold in the U.S. used as a proxy for low­est lev­el of U.S. avail­abil­i­ty. FDA found that on­ly 35 per­cent of these drugs were avail­able in the oth­er nine coun­tries and 65 per­cent of these drugs ap­pear to be un­avail­able,” he added.

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.


Zachary Brennan

managing editor, RAPS

John Hood [file photo]

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