Got­tlieb seeks new com­par­a­tive ap­proval stan­dard for opi­oids

With just a week left be­fore he de­parts from the FDA, Com­mis­sion­er Scott Got­tlieb on Thurs­day told the Sen­ate Ap­pro­pri­a­tions Com­mit­tee that his agency is in­ter­est­ed in Con­gress cre­at­ing a new stan­dard for opi­oid ap­provals where­by those seek­ing ap­proval would be com­pared to opi­oids al­ready on the mar­ket.

“For this to work, the FDA be­lieves that there should be a pre­mar­ket demon­stra­tion that a new opi­oid is su­pe­ri­or to an al­ready-ap­proved opi­oid or opi­oid-con­tain­ing drug for the same gen­er­al in­di­ca­tion. The stan­dard should be that a new opi­oid or opi­oid-con­tain­ing drug pro­vides a sig­nif­i­cant ad­van­tage rel­a­tive to an al­ready-ap­proved opi­oid or opi­oid-con­tain­ing drug for the same gen­er­al in­di­ca­tion in terms of greater ef­fi­ca­cy or greater safe­ty,” he said.

Drugs that meet this new stan­dard could re­ceive break­through or some oth­er new des­ig­na­tion to fur­ther pri­or­i­tize their re­view. “Even­tu­al­ly, Con­gress could con­sid­er how oth­er in­cen­tives, in­clud­ing ex­clu­siv­i­ty pe­ri­ods, might help dri­ve de­vel­op­ment to­ward drugs with safer at­trib­ut­es,” Got­tlieb added.

While ac­knowl­edg­ing that opi­oids need to be treat­ed dif­fer­ent­ly from oth­er prod­ucts, he al­so said FDA is work­ing to im­ple­ment dif­fer­ent pro­vi­sions from the Sup­port Act, in­clud­ing new re­quire­ments for longer ef­fec­tive­ness stud­ies and oth­er au­thor­i­ties that al­low FDA to re­quire cer­tain pack­ag­ing to be made avail­able for opi­oids that pose a se­ri­ous risk of abuse or over­dose.

“The ques­tion is long-term safe­ty when these drugs are used chron­i­cal­ly, in par­tic­u­lar whether ef­fi­ca­cy de­clines and if that cre­ates safe­ty is­sues,” Got­tlieb said.

But on the ques­tion of whether any com­pa­ny is close to bring­ing a non-opi­oid painkiller to mar­ket, Got­tlieb said they’re in the ear­ly stages of de­vel­op­ment and it’s dif­fi­cult to pre­dict how quick­ly such a prod­uct would come to mar­ket.

He al­so did not seem to think the in­flux of il­lic­it opi­oids was un­der con­trol. “I don’t know that I can say we have a han­dle on it or an un­der­stand­ing of the full scope,” he added.

In ad­di­tion to the opi­oids dis­cus­sion, Sen. Patrick Leahy (D-VT) asked Got­tlieb about the agency’s frame­work for ap­prov­ing biosim­i­lar in­sulins, which is shift­ing in 2020 as prod­ucts ap­proved un­der new drug ap­pli­ca­tions are tran­si­tioned to bi­o­log­ics li­cens­es.

Got­tlieb said he thought that un­der the new biosim­i­lars path­way, “we’ll see much more com­pe­ti­tion” for in­sulins, as it will be eas­i­er to get to mar­ket and com­pete as in­ter­change­able prod­ucts. He ac­knowl­edged there may be one or two ap­pli­ca­tions that get caught and have to be re­sub­mit­ted be­cause of the shift, but he in­sist­ed there will be “vig­or­ous ac­tiv­i­ty un­der the new frame­work.”

He al­so said he hopes Con­gress would reau­tho­rize the im­por­tant biosim­i­lar ap­proval path­way, which is part of the Af­ford­able Care Act, if the ACA were in­val­i­dat­ed.

In his writ­ten tes­ti­mo­ny, Got­tlieb al­so dis­cussed trans­form­ing med­ical de­vice safe­ty and cy­ber­se­cu­ri­ty, med­ical coun­ter­mea­sures and drug com­pound­ing.

Im­age cred­it: Shut­ter­stock

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

Hal Barron, GSK

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