FDA Schedules Public Meeting to Negotiate BsUFA Reauthorization

In preparation for a September 2017 expiration, the FDA has scheduled a Dec. 18 public meeting to kick off reauthorizing the Biosimilar User Fee Act.

The agency is seeking feedback on BsUFA’s overall performance, which goals should be retained, changed or discontinued and the program’s user fee structure.

Drugmakers may ask the FDA to streamline the fee structure, says Kurt Karst, an attorney with Hyman Phelps & McNamara. The program was in its infancy five years ago, and the current segmented structure may not be needed as BsUFA moves forward, he said.

Kay Holcombe, senior vice president for science policy at BIO, agrees. “The structure was intended to work in a situation where there were no marketed products yet, and FDA had little to no clarity about how many or when applications would be submitted,” she says. “There may be a better understanding going into this reauthorization of how the market will evolve, and thus ideas for a different type of structure.”

Brian Malkin, an attorney with McGuireWoods, says he’s not aware of any other big issues. “From what I have heard informally from a variety of sponsors, they generally have been pleased with their meetings at FDA and appreciate that the fees are necessary,” he said.

The deadline for registering to attend the meeting is Nov. 18. Read the Federal Register notice here: www.fdanews.com/9-15-BsUFA-Notice.pdf. — Jonathon Shacat