FDA user fee bill dead­line falls apart? Thou­sands of pink slips for FDA could be com­ing as Burr seeks to start anew

The bat­tle over what to in­clude in this lat­est round of user fee leg­is­la­tion — the in­dus­try mon­ey that pays for all bio­phar­ma drug and bi­o­log­ic re­views at the FDA and has to be reau­tho­rized every five years — is com­ing to a head as Con­gress looks to meet an Au­gust re­cess dead­line be­fore the FDA has to send out thou­sands of warn­ings to much-need­ed re­view­ers that they’ll be soon laid off.

Not on­ly would the FDA be forced to send the pink slips, but all cur­rent PDU­FA dead­lines would grind to a halt as the agency would no longer have the staff to meet its re­view dead­lines.

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