PDUFA Cost Offset In House Focuses On FDA Petition Review, Not REMS
Faced with a CBO estimate that H.R. 5651 will increase federal spending in fiscal years 2013 through 2022, the House Energy and Commerce Committee applies a section that speeds FDA decisions on some petitions to biosimilars. This contrasts with the Senate bill, which allows FDA to require brand companies to sell products covered by limited distribution systems to generic firms.
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House and Senate avoided some contentious issues when passing their user fee bills, leaving them to an informal conference committee to work out, ideally before the end of June.
Bill moves to conference committee with House passage under suspension of the rules, but negotiators will have to reconcile pay-fors and track and trace differences.
After about a week of debate, the Senate overwhelmingly passes its FDA user fee package, with only track and trace to be finalized. House members are scheduled to begin floor debate after Memorial Day in the hopes of sending the bill to President Obama before July 4.