With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Sen­ate won’t re­turn from its sum­mer re­cess un­til Sept. 6, but when it does, it of­fi­cial­ly has 18 busi­ness days to fi­nal­ize the reau­tho­riza­tion of the FDA user fee pro­grams for the next 5 years, or else thou­sands of drug and bi­o­log­ics re­view­ers will be laid off and PDU­FA dates will van­ish in the in­ter­im.

FDA com­mis­sion­er Rob Califf re­cent­ly sent agency staff a memo ex­plain­ing how, “Our lat­est es­ti­mates are that we have car­ry­over for PDU­FA [Pre­scrip­tion Drug User Fee Act], the user fee fund­ing pro­gram that will run out of fund­ing first, to cov­er on­ly about 5 weeks in­to the next fis­cal year.”

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