FDA sug­gests new user-fee pro­grams for drug­mak­ers

Modern Healthcare - - LATE NEWS -

The Food and Drug Ad­min­is­tra­tion sent Congress rec­om­men­da­tions for two new user-fee pro­grams for drug­mak­ers that would help pay for quicker re­views of ap­pli­ca­tions for generic and biosim­i­lar drugs. The pro­pos­als were in­cluded with the FDA’S rec­om­men­da­tions for the reau­tho­riza­tion of the Pre­scrip­tion Drug User Fee Act of 1992, which FDA Com­mis­sioner Dr. Mar­garet Ham­burg said in a news re­lease has “en­sured a pre­dictable, con­sis­tent and stream­lined pre­mar­ket pro­gram” for brand-name drugs. The pro­posal for a generic-drug user fee calls for the in­dus­try to pay $299 mil­lion each year, in­clud­ing a $50 mil­lion fee to ad­dress pend­ing ab­bre­vi­ated new-drug ap­pli­ca­tions. The agency in turn would re­view 90% of ab­bre­vi­ated new-drug ap­pli­ca­tions within 10 months of sub­mis­sion. The FDA, which re­ceives up to 900 new generic-drug ap­pli­ca­tions each year, said ap­pli­ca­tions are ris­ing and user fees would be used to hire additional staff and im­prove gener­ic­drug re­view sys­tems. Ralph Neas, pres­i­dent and CEO of the Generic Phar­ma­ceu­ti­cal As­so­ci­a­tion, said in a state­ment that the pro­posal is “an im­por­tant land­mark.” The pro­posed biosim­i­lar user-fee pro­gram would ad­dress prod­ucts ap­proved un­der a new “ab­bre­vi­ated” ap­proval process for those prod­ucts. Congress must reau­tho­rize the cur­rent drug user-fee pro­gram by Septem­ber.

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