Next user fee deal re­veals where in­dus­try won at the ne­go­ti­at­ing ta­ble with FDA

Every five years, the way the FDA and the bio­phar­ma in­dus­try in­ter­act changes, some­times more than a lit­tle bit. While the tried and true process­es of drug­mak­er-FDA in­ter­ac­tions re­main in­tact, in­dus­try and the FDA spend months at the ne­go­ti­at­ing ta­ble hash­ing out new ways to al­ter their in­ter­ac­tions and al­low for a more con­sis­tent, pre­dictable process.

In the case of PDU­FA VII, which takes ef­fect in Sept. 2022 and runs through 2027, the 71-page com­mit­ment let­ter be­tween the FDA and in­dus­try re­leased Mon­day spells out ex­act­ly what to ex­pect if you’re a spon­sor of a new drug ap­pli­ca­tion, weav­ing through this some­times labyrinthine process.

The let­ter al­so of­fers a win­dow in­to the FDA’s long-term pri­or­i­ties, par­tic­u­lar­ly on safe­ty-re­lat­ed is­sues, such as mod­ern­iz­ing REMS as­sess­ments, us­ing user fees to ex­pand the FDA’s Sen­tinel ini­tia­tive for track­ing the safe­ty of mar­ket­ed drugs, and re­view­ing pro­pri­etary names to re­duce med­ica­tion er­rors.

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