House pass­es bi­par­ti­san FDA user fee leg­is­la­tion as it aligns with Sen­ate on ac­cel­er­at­ed ap­proval re­forms

Last night the House over­whelm­ing­ly passed a pack­age of leg­is­la­tion, by a vote of 392-28, that will reau­tho­rize FDA user fee pro­grams — fund­ing agency re­views of drugs, med­ical de­vices, gener­ics and biosim­i­lars — as well as oth­er at­tached re­forms, set­ting up what is ex­pect­ed to be some heavy ne­go­ti­at­ing with the Sen­ate as the two sides have sev­er­al ma­jor dif­fer­ences.

The quin­quen­ni­al (every 5 years) user fee bill will ful­ly fund the FDA and al­low the agency to hire new re­view­ers, par­tic­u­lar­ly in CBER, and hit new re­view marks as out­lined in the user fee deals that the FDA and bio­phar­ma com­pa­nies forged over the past sev­er­al years. (Con­gres­sion­al ap­pro­pri­a­tions make up less than half of the FDA’s lat­est bud­get.)

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