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All Eyes on Senate After House Passes User Fee Reauthorization Bill, RAPS

Thursday, June 9, 2022

The US House of Representatives recently passed the long-awaited US Food and Drug Administration (FDA) user fee reauthorization bill. All eyes are now on the US Senate, which is expected to hold a postponed markup hearing on its version of the bill that includes several other provisions.

In discussing the differences between the two versions with the Regulatory Affairs Professionals Society (RAPS), partner Jackie Berman commented that the Senate and House versions of the bill do not address drug development the same way. Neither bill addresses rare disease product development or cases where there are unmet needs—an area Jackie is particularly focused on.

“What the House bill does do is require that there be various studies that report to Congress regarding the approval of rare disease products, and the kind of information and data goes into those approvals, including the patient voice and the physician perspective,” said Jackie. “And this may be setting the stage for more things to come in the future as far as legislative development.”

Read the full RAPS article >>