Today FDA announced that it will hold a public meeting on October 20, 2016 to discuss its proposed recommendations for the reauthorization of the Biosimilar User Fee Act, which permits FDA to collect fees and use them for the process for the review of aBLAs. The current legislative authority for BsUFA expires in September 2017, and the meeting will discuss reauthorization of BsUFA for fiscal years 2018 through 2022.
FDA’s proposed recommendations can be found on pages 6-14 of the announcement, and address a variety of issues. For example, the recommendations propose to allow for additional communication between FDA review teams and aBLA applicants both pre- and post-submission; to provide a mechanism for allowing written responses in place of in-person or telephonic meetings; to provide additional guidance on biosimilar development; to improve FDA’s hiring and retention of review staff; to enhance FDA’s staff capacity to develop new regulations and guidance, develop or revise policy and procedure manuals, templates and training; to improve FDA’s ability to analyze resource needs and capacity; to change or establish fee structures; and to change an assortment of timeframes.
FDA’s announcement solicits comments on the public docket (FDA-2015-N-3326) regarding its proposed recommendations. FDA will consider any public comments and revise its recommendations as necessary. Comments must be submitted within 30 days of the announcement’s publication in the Federal Register; the announcement is slated for publication on September 19, so any comments will need to be submitted by October 19. [see update below]
The meeting will be held from 9 am to 2 pm at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503, Section A), Silver Spring, MD 20993-0002. The FDA asks expected participants to register by October 19 at http://bsufapublicmeeting.eventbrite.com.
UPDATE (9/28/16): Today, FDA announced that it was correcting its prior announcement to change the deadline for submitting electronic or written comments from October 19, 2016 to October 28, 2016.