PDUFA V Action Heats Up On Hill With House Hearings In February
This article was originally published in The Pink Sheet Daily
Executive Summary
An Energy and Commerce subcommittee will discuss the FDA and industry agreement on prescription drug user fees with FDA Commissioner Margaret Hamburg Feb. 1. Drug shortages will be part of the deliberations Feb. 7 when CDER Director Janet Woodcock goes before the panel to make the case for user fees on generic drugs and biosimilars.
You may also be interested in...
Shortage Notification May Have Legislative Momentum Again After BIO Questions Reimbursement Fix
Preventing shortages through increased communications with manufacturers could gain the upper hand in part because creating economic incentives may prove too difficult and controversial.
Biosimilar, Generic and Rx User Fees Rely On Different Adjusters For Needed Appropriations
The biosimilar and generic drug user fees use different CPI measures, meaning they could increase the appropriations needed to allow user fee collection at different rates.