User Fees
Novel agents from the biologics center had a median review time of 10.6 months, beating the drugs center's median of 11.8 months thanks to fewer multicycle and more priority reviews.
The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.
The December calendar features nearly 20 user fee goal dates, from Novo Nordisk’s Alhemo to Lexicon’s Zynquista.
While annual fees for marketing authorization applications and annual payments to the European Medicines Agency are set to increase from 2025, micro-sized companies and SMEs that make orphan drugs will still benefit from full reductions.
Pink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization, as well as the changes Dr. Mehmet Oz, President-elect Donald Trump’s controversial selection to run the US Centers for Medicare and Medicaid Services, could impose if confirmed.
Expected HHS Secretary nominee Robert F. Kennedy Jr.'s dislike of user fees and interest in major FDA reforms could come to a head in the 2027 PDUFA reauthorization.
The FDA’s Peter Marks warned novel approvals will suffer if the agency is forced to spend its time relitigating vaccines. At the top HHS post Kennedy could impact pharma from basic research funding to drug pricing.
Another record-breaking year for novel approvals looks out of reach, but the six novel agents with November goal dates show the continued strength of rare disease drug development.
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.
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.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Teva requested the change to the draft guidance, arguing that otherwise the meetings would be “completely one-sided conversations.”
Pink Sheet infographic shows that while overall growth continues at the drugs and biologics centers, the US FDA still must add many employees to meet user fee-mandated hiring goals.
A lack of process documentation was part of the reason the FDA forgot to account for fee refunds in its estimates of incoming applications for two fiscal years, a mistake that likely cost the agency millions in revenue.
Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August, a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi, and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews.
A stacked user fee goal lineup sets the stage for market showdowns in primary biliary cholangitis and IgA nephropathy, the first psychedelic approval decision, and lots of targeted cancer therapies.
The agency used a 10-year average with updated figures to calculate the FY 2025 PDUFA application fee and limit the impact of submission volatility, but still allowed GDUFA and BsUFA fees to skyrocket.
But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during session on meeting management best practices.