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Regulatory News | 14 July 2022 | By Michael Mezher
Updated 14 July 2022 to include a statement from Sen. Patty Murray (D-WA).
Up against a tight timeline and divergent user fee reauthorization bills in the two chambers of Congress, Senate Health, Education, Labor and Pensions (HELP) committee Ranking Member Richard Burr (R-NC) on Thursday introduced a “clean reauthorization” bill that strips out several riders from the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act.
The alternate user fee reauthorization bill comes as concerns about the timeline for passage mount, given the differences that exist between the House-passed Food and Drug Amendments of 2022 (FDA22) bill and FDASLA, which squeaked through committee last month. Burr said that his bill, dubbed the Food and Drug Administration Simple Reauthorization Act “represents the clearest past forward” for the must-pass package.
As reported by Politico Pro on Wednesday, Burr said he thinks “it’s doubtful” that several of the riders contained in FDASLA relating to diagnostics, dietary supplements and cosmetics are retained in a final version of the bill. The House FDA22 bill does not contain those provisions and they would need to be addressed during the reconciliation process, and the House bill contains multiple provisions that are not included in either of the Senate bills. (RELATED: All eyes on Senate after House passes user fee reauthorization bill, Regulatory Focus 9 June 2022; Senate HELP sends user fee reauthorization bill to floor vote, Regulatory Focus 14 June 2022)
While Burr praised the core user fee package that came out of the HELP committee earlier this year, he said the riders “would, if enacted, undermine the very purpose of the user fee program. The policies added to this bill endanger the development of drugs for rare diseases, imperil intellectual property rights, threaten Americans’ access to breakthrough treatments and cures, and deter private sector innovation.”
In a statement, HELP committee Chair Patty Murray (D-WA) said that the focus should be to pass FDASLA with its riders on prescription drug importation, cosmetics, and dietary supplements, which she says address issues that are important to constituents.
"The bipartisan bill that I introduced with Senator Burr just weeks ago—and which advanced out of our committee in a bipartisan way—made meaningful progress on all of these issues. It is a strong, bipartisan bill that will make sure FDA has the tools and resources it needs to fulfill its mission and keep families safe and healthy, and that we have the accountability we need to know FDA is living up to that critical responsibility," Murray said.
The stakes are high for FDA; if the agreements are not reauthorized by the end of September, the agency will be faced will laying off much of its medical product review staff whose positions are funded by the user fees.
Speaking to the Alliance for a Stronger FDA on Tuesday, FDA Commissioner Robert Califf said the implications of not reauthorizing the agreements would be “enormous.” (RELATED: Califf: ‘Enormous’ implications for FDA if user fee programs are not reauthorized, Regulatory Focus 12 July 2022)
“On the medical products side, this is a very significant part of funding and basically we’d have to lay people off,” Califf said, adding that even the specter of layoffs could dent the agency’s ability to recruit staff.
“We’re in the period of the ‘Great Resignation’ … who wants to work in an organization if you’re afraid that these jobs are not even going to exist in the next short period of time? We really need to avoid that,” Califf said.
In her statement, Murray said that the prospect of FDA handing out pink slips is unacceptable and insisted that the best path forward would be to focus on the bipartisan bill that was voted out of committee last month.
Steven Grossman, executive director of the Alliance for a Stronger FDA, told Focus the user fee reauthorization process has often presented an opportunity for Congress to address other issues under FDA’s purview, such as the provisions related to inspections and generic drug access contained within the FDA Reauthorization Act of 2017.
“Over the last few user fee reauthorization cycles, the legislative vehicle containing the user fees has provided a means for Congress to adopt many important provisions that have strengthened FDA and improved the agency’s ability to protect the health and safety of Americans. There are many such provisions in the current House and Senate versions of the legislation,” Grossman said.
“However, the only essential task for Congress is the reauthorization of the user fee agreements. Without that, lay-off notices will go to several thousand FDA employees on August 1. Then on October 1, there is the possibility that those individuals would no longer have jobs and there would be a nearly $2 billion hole in the agency’s budget,” he added, noting that the ultimate decision about what is included in the reauthorization package rests with legislators, not the agency’s stakeholders.
Stakeholders don’t decide what happens--this rests solely on the shoulders of Senators and Representatives. We can only hope the net impact is positive for both FDA and the American people.”