PhRMA calls for FDA to address unique needs of biosimilar review program

By Nick Taylor

- Last updated on GMT

© GettyImages/Richard Drury
© GettyImages/Richard Drury

Related tags: Biosimilars, Fda

PhRMA has called for the US FDA to ensure its capacity planning adjustment (CPA) methodology addresses the “unique needs” of the biosimilar review program.

The CPA methodology is designed to adjust the FDA’s annual base revenue in response to changes in the resources needed to review human drug, biologic and biosimilar product submissions. Based on the number of full-time-equivalent (FTE) staff the methodology calculates are needed, the FDA will adjust the annual target revenues for its prescription drug and biosimilar user fee agreements.

On July 19, PhRMA, the trade group also known as Pharmaceutical Research and Manufacturers of America, provided feedback on the CPA methodology in response to an FDA public meeting on the financial efficiency of the human drug user fee programs.

PhRMA said it “generally​” supports the new CPA methodology “as it helps to align the appropriate resources to the workload fluctuations and allocate the resources to the proper program areas and review activities​.”

The trade group identified areas for improvement, though, including one point specific to the biosimilar program, known by the abbreviation BsUFA.

FDA should ensure that the application of the CPA methodology to BsUFA addresses the biosimilar review program’s unique needs and that resources are available and proportionate to its workload demands​,” wrote PhRMA in feedback to the agency.

Reallocation of FDA staff urged 

PhRMA also flagged up more general points that apply to both human drugs and biosimilars. The trade group wants to see “effective and timely reallocation​” of FDA staff and resources “to address changing priorities and workload​.”

PhRMA also commented on the impact of the FDA’s staffing situation on the methodology. “Given the challenges the Agency faces on recruiting, hiring and retaining staff, it will be important to understand how the total CPA is allocated between FTE resources and other operating expenses​,” wrote the trade group.

The feedback features other comments on BsUFA. PhRMA said the program “requires more flexibility in resources to address volatility in user fee collections and challenges in forecasting​,” making it “important that FDA outlines a plan to manage the BsUFA carryover balance​.” 

PDUFA, the prescription drug equivalent of BsUFA, is more established and user fee revenues are now relatively consistent with expectations, making carryover balances less of an issue than in the past.

Related topics: Markets & Regulations, Biosimilars

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