Manatt Health Partner Rachel Sher spoke with MM+M about the Food and Drug Administration (FDA) user fee reauthorization bill, which would reauthorize all user fees for drugs, medical devices, generic drugs and biosimilars, as well as bolster the FDA’s work in reviewing the safety and efficacy of drugs.
The Senate released a draft version of its user fee bill, which must be reauthorized by the end of the fiscal year or the FDA loses its statutory authority to collect fees from any of the programs, according to Sher. “The user fee reauthorization bill itself is always conceived as a must-pass vehicle because user fees today represent such a large proportion of the respective medical product center’s budget and the critical activities those centers do,” she said. Congress is divided on what provisions to include, however, namely accelerated approval reforms that helps the FDA approve drugs more quickly. “It’s unusual to see the House and Senate contain such significant provisions that are not reflected in the other chamber’s bill,” Sher noted. “Given the strong bipartisan interest that we saw in the House for looking at necessary changes and improvements to the accelerated approval pathway, this is a provision that I think we can expect to see added somewhere along the line in the Senate process too.”
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