Aim­ing for more copy­cats of each brand­ed drug, FDA ex­pands gener­ic drug pri­or­i­ty re­views

Talk of bring­ing down the price of phar­ma­ceu­ti­cals of­ten hinges on gener­ic com­pe­ti­tion, and the US is see­ing ap­provals of new gener­ic drugs faster and more con­sis­tent­ly than ever — a trend like­ly to con­tin­ue.

The progress comes as FDA com­mis­sion­er Scott Got­tlieb on Thurs­day in­di­cat­ed that the agency will ex­pand which ab­bre­vi­at­ed new drug ap­pli­ca­tions (AN­DA) will see pri­or­i­ty re­views.

“Ear­li­er this year we made changes to how we pri­or­i­tize the agency’s gener­ic drug sub­mis­sions. The goal was to pri­or­i­tize the re­view of gener­ic ap­pli­ca­tions un­til the FDA has ap­proved three gener­ic ver­sions of each par­tic­u­lar drug,” Got­tlieb said in a state­ment. “To­day we’re ex­pand­ing this com­pe­ti­tion-fo­cused pol­i­cy to pri­or­i­tize any ap­pli­ca­tion that can meet the FDA’s ap­proval stan­dards at the point when the 180-day ex­clu­siv­i­ty pe­ri­od ex­pires on a first gener­ic en­trant to a brand­ed med­i­cine.”

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