User Fee Reauthorization Prompts More Intensive FDA Assessment of Its Growing Biosimilar Regulatory Experience

The Biosimilar User Fee Act (BsUFA) reauthoritization process has driven an intensive assessment by FDA of its growing body of regulatory experience to determine where the difficulties have been in the first five years of the user fee program and what can be done to address them.

The current initial authorization for collecting the biosimilar user fees ends in September 2017. During 2016, FDA has been assessing its experience with the program and formulating its plans to improve it in conjunction with the user fee reauthorization for FY 2018 through 2022 (BSUFA II). 

Engaged with FDA in the assessment process have been Congress, scientific and academic experts, health care professionals, patient and consumer advocacy groups, and industry.

The FD&C Act calls for FDA to sequentially: ‚óŹ publish recommendations for the reauthorization ‚óŹ provide a 30-day comment period ‚óŹ hold a meeting for stakeholder input, and ‚óŹ revise the recommendations as necessary based on the written and meeting comments. The final recommendations to Congress are due in mid-January, 2017.

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