Regulatory Focus™ > News Articles > 2021 > 9 > Pharmaceutical industry signals support for FDA’s BsUFA III commitment letter

Pharmaceutical industry signals support for FDA’s BsUFA III commitment letter

Posted 29 September 2021 | By Joanne S. Eglovitch 

Pharmaceutical industry signals support for FDA’s BsUFA III commitment letter

Two major pharmaceutical industry groups have endorsed the US Food and Drug Administration’s (FDA’s) recent commitment letter under its Biosimilar User Fee Amendments (BsUFA III) program which will run from FY 2023 to 2027, calling it an “an important milestone.”
After months of negotiation with industry, FDA released the commitment letter for the third iteration of BsUFA III in mid-September (RELATED: BsUFA III commitment letter details FDA, industry goals for biosimilars program, Regulatory Focus, 21 September 2021). The letter details the agency’s performance goals for the program in exchange for collecting user fees.
 “We applaud the FDA for working diligently with industry in our ongoing efforts to continue to improve the BsUFA User Fee program,” announced the Association for Accessible Medicines on 21 September.
AAM highlighted key points of The BsUFA III performance goals letter expands on the BsUFA II goals letter,” which expires on 30 September.
The Pharmaceutical Research and Manufacturers of America (PhRMA) similarly praised the commitment letter in a 21 September announcement. Its release is “an important milestone in the ongoing evolution of the biosimilar marketplace in the US,” wrote the trade association. PhRMA was also heartened by BsUFA III’s “increased options for patients and decreased prescription drug spending.”
PhRMA said that currently, there are 31 FDA-approved biosimilar products, including one interchangeable biosimilar, and estimates that there are nearly 100 active biosimilar development programs paying BsUFA fees.
The BsUFA program generally receives high grades from the biopharmaceutical industry. In April, three industry groups, PhRMA, the Biosimilars Forum and the Biosimilars Council expressed positive reviews for the program in a third-party interim assessment. (RELATED:  Biosimilars industry weigh in on BsUFA II interim assessment, Regulatory Focus, 2 April 2021)
The FDA’s budget is increasingly being funded by the industry it regulates through user fees, according to the Congressional Research Service (CRS). In its 21 June report on the FDA’s budget, the organization reports the agency’s spending from user fees has generally increased, both in absolute terms and as a share of FDA’s total budget, accounting for over 45% of the agency’s FY2020 total program level, since the enactment of the first user fee program, Prescription Drug User Fee Act (PDUFA) in 1992.
Over the years, FDA’s biologics program budget has grown from $340 million in FY2017 to $458 million in the FY2022 request. The proportion of the biologics program funded by industry has increased moderately, from approximately 36% in FY2017 to 41% in the proposed FY2022 budget.
According to the report, the human drugs program comprises the largest portion of FDA’s budget (33% in FY2021), followed by the foods program (18% in FY2021), and the tobacco program (11% in FY2021), which is funded solely by tobacco product user fees.
AAM statement
PhRMA statement
CRS report on user fees


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Tags: BsUFA, FDA

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