US FDA User Fees
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Furloughs would allow affected FDA staff to remain employed, while a layoffs would require affected workers to be rehired.
Senate appropriations bill would take back some of the increase the House offered the Center for Drug Evaluation and Research and other programs, setting up negotiations as next fiscal year nears.
Pink Sheet reporter looks at the biggest US FDA and pharma industry stories of the week, including the status of US FDA user fee renewal legislation, new real-time oncology review program guidance, Biogen’s ALS accelerated approval play, and Teva settling opioid litigation.
The notices normally would go out on 1 August, but unspent user fee funds may be able to sustain work for a few weeks if the program expires.
Popular characteristics like goal dates are expected to remain in place if Congress does not renew the user fee programs by 1 October.
The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.
US FDA wants the program, intended to help speed ANDA approvals, utilized more, but industry still questions the information that must be submitted.
Sen. Richard Burr introduces a reauthorization bill without any policy changes, even ones he previously endorsed, saying it’s the clearest path forward now.
Outlining what changes he wants to see at the agency before he leaves, Califf also worries congressional inaction on the user fee reauthorization could affect hiring efforts.
Senators Richard Burr and Bernie Sanders do not typically agree on many issues. But during consideration of the US FDA user fee reauthorization package, both expressed concern that the increasing fees contribute to higher drug prices – and both voted against moving the package forward.
The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.
The requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.
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