It seems like there’s momentum to fund the FDA’s Sentinel Initiative via PDUFA. Although, according a report in the Pink Sheet, “Industry is not interested in blindly pumping user fee revenue into the project.”
Per industry suggestions, only specific Sentinel projects would be funded by user fees and an open process would be required to make the determinations,
FDA and industry also talked about possibilities of establishing a process for determining which Sentinel projects were eligible for user fees, according to minutes of a January 10 meeting.
(Ain't transparency grand?)
The proposal would limit user-fee funded Sentinel projects to those that would “emphasize safety issues that affect classes of drugs or multiple products,” according to the minutes.
Also required would be an assessment of Sentinel’s value to regulatory decision-making on safety issues and adjustments to resource needs accordingly, with the evaluations targeted for fiscal years 2015 and 2017.
The minutes indicated both sides have agreed to the proposal and will present it to the full committee for consideration.
FDA also agreed to better describe how regulatory science upgrades would be relevant to the review model and PDUFA.
Saying publicly what has to-date only been whispered privately, both sides seem to be reaching agreement that funding for the agency’s initiative on advancing regulatory science (the Advancing Regulatory Science Initiative or ARSI) is a PDUFA-worthy proposition.
Does this foreshadow new and robust agency/industry collaboration?Stand by.
"One must have a good memory to be able to keep the promises one makes."
-- Friedrich Nietzsche
