FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

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.”

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Life Sciences Senior Associate

General Catalyst

San Francisco, CA, USA