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User Fees
“It's kind of a free for all,” says longtime FDA funding advocate Steven Grossman. FDA knew funding it requested “was totally inadequate to the needs. So, Food Chemical Safety is stuck there with about six or eight other purposes the money could have been used for.
FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.
Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’
FDA Office of Nonprescription Drugs explains in its proposed commitment letter for fiscal years 2026-2030, based in part on suggestions by stakeholders, that it will heighten its attention to collecting those fees.
The STAR pilot established in PDUFA VII for efficacy supplements, which was modeled after the popular Real Time Oncology Review program, has not garnered much interest. The agency now is establishing a separate but similar pilot for a small number of original NDAs and BLAs.
The number of standard and priority reviews also decreased significantly in FY 2023 compared to the previous year, which caused the fee for redeeming a voucher to rise.
Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.
Advisory committee concerns cast clouds over Iterum’s oral antibiotic, Intercept’s Ocaliva, and perioperative immuno-oncology regimens, while CSL and Pfizer aim to take their hematology franchises in new directions.
Inflation accounted for a larger portion of user fee revenue target increases for fiscal year 2025, compared to previous years, according to a Pink Sheet analysis.
FDA is considering allowing MIDD meeting requests to be submitted more often than the current quarterly schedule, but agency must have a plan to deal with the likely increased demand, official says.