FDA fi­nal­izes rules on faster ap­proval for some drugs

Modern Healthcare - - NEWS - By Vir­gil Dick­son

The Food and Drug Ad­min­is­tra­tion has pub­lished fi­nal guid­ance to help man­u­fac­tur­ers of drug and bi­o­log­ics bring prod­ucts for treat­ment of un­met needs to the mar­ket faster than they can through the usual ap­proval path­ways.

“For those drugs that qual­ify, par­tic­i­pat­ing in one of these ex­pe­dited pro­grams can re­duce the time and pos­si­bly the cost of de­vel­op­ing new ther­a­pies that can save lives,” Dr. Janet Woodcock, di­rec­tor of the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search, said in a writ­ten state­ment. “That’s a win for drug in­no­va­tion and for pa­tients.”

The guid­ance de­scribes four expe- dited pro­grams and the cri­te­ria that qual­ify prod­ucts for these faster path­ways. These in­clude fast-track des­ig­na­tion, break­through ther­apy des­ig­na­tion, ac­cel­er­ated ap­proval and pri­or­ity re­view des­ig­na­tion. A draft ver­sion of the guid­ance, which re­ceived com­ments from ma­jor com­pa­nies in­clud­ing Merck & Co., No­var­tis and Pfizer, was re­leased last sum­mer.

The reg­u­la­tions are in­tended to speed the avail­abil­ity of new ther­a­pies to pa­tients with se­ri­ous con­di­tions, es­pe­cially when there are no sat­is­fac­tory al­ter­na­tive ther­a­pies, while pre­serv­ing ap­pro­pri­ate stan­dards for safety and ef­fec­tive­ness. The FDA said the reg­u­la­tions rec­og­nize that “pa­tients and physi­cians are gen­er­ally will­ing to ac­cept greater risks and side ef­fects from treat­ment of life-threat­en­ing and se­verely de­bil­i­tat­ing dis­eases than they would for other dis­eases.” The agency also rec­og­nized that cer­tain as­pects of drug de­vel­op­ment that are fea­si­ble for com­mon dis­eases might not be fea­si­ble for rare dis­eases and that de­vel­op­ment chal­lenges are of­ten greater with in­creas­ing rar­ity of the dis­ease.

Nearly half of the 27 new drugs the FDA ap­proved last year took ad­van­tage of at least one of these ex­pe­dited drug de­vel­op­ment and re­view ap­proaches, with re­view times as short as 4½ months. That com­pares with the year or more re­view pe­riod for other drugs, ac­cord­ing to the agency.

The re­lease of the fi­nal guid­ance comes nearly three months af­ter the FDA alerted drug­mak­ers that they have to change la­bel­ing on drugs ap­proved through the ac­cel­er­ated ap­proval path­way so doc­tors and pa­tients know such ap­provals could sub­se­quently be re­voked.

Ap­proval granted through one of these pro­grams can be re­voked in cases where a trial re­quired to ver­ify the clin­i­cal ben­e­fit of the prod­uct fails to doc­u­ment that ben­e­fit. Other cri­te­ria for re­vo­ca­tion in­clude when ev­i­dence comes to light the prod­uct is not safe or ef­fec­tive, and when a man­u­fac­turer does not con­duct the re­quired postap­proval trial of the drug or dis­sem­i­nates false or mis­lead­ing pro­mo­tional ma­te­ri­als re­lat­ing to the prod­uct.

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