User Fees
Non-malignant hematology, respiratory and cardiometabolic candidates make up for an unusual lack of oncology products on the US FDA’s December user fee goal calendar.
The FDA wants to charge a yearly fee after an IND is filed for firms that do not conduct Phase I clinical studies in the US as part of its proposal to encourage more domestic development.
The FDA told the Pink Sheet an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
The message that the US may lose its lead in biotech to China appears to have bipartisan resonance on Capitol Hill. That sets a favorable context for the kickoff of the next user fee reauthorization process.
Elevating the Office of Therapeutic Biologics and Biosimilars out of the Office of New Drugs and providing signatory authority could help speed biosimilar reviews, OTBB Director Sarah Yim said.
But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.
The next iteration of the user fee program could depart from longstanding agency commitments to issue formal guidance given the Trump Administration’s deregulatory philosophy, policy experts said.
The issues surrounding the FDA's Center for Drug Evaluation and Research director are raising new concerns about more career staff attrition, which likely will negatively impact the drug industry.
An agency official said reserve user fee money is expected to continue funding application review and other activities for several more weeks.
The introductory meeting did not suggest changes to the expected schedule and operations for renewing the generic drug user fee, said AAM’s Giuseppe Randazzo.
The FDA only added 39% of the promised new user fee-related hires in FY 2025 and also missed hiring goals for the previous two fiscal years.
The hiring and departure data provide more evidence of the extent of the Trump Administration’s efforts to shrink the FDA workforce through cuts and voluntary departures.
Both programs were expected to slightly under-collect fees, similar to FY 2024, but an assessment determined the capacity planning adjustment was accurately forecasting the necessary revenue.
October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.
FDA shutdown plans indicate about 86% of staff would be retained, a rate that is higher than previous plans, but reserve funding would not last more than a few months.
The FDA said new molecular entity application reviews increased and cost less in fiscal year 2024, a potentially encouraging sign for industry.
The administration's first actions on drug advertising linked to a new MAHA Strategy report may suggest more specifics about its plans exist than in the limited text of the report.