In an email to agency staff earlier this week, FDA commissioner Scott Gottlieb said he will delay issuing layoff notices until after September 30th — when the agency’s current user fee agreements expire. Previously, the FDA indicated it could issue layoff notices to thousands of staffers funded by user fees should Congress not act by August 1st.
In the email, Gottlieb says he’s optimistic the Senate will take up the matter soon and the agency can “reasonably expect” reauthorization to occur before the September 30th deadline.
As such, Gottlieb says the agency does “not anticipate initiating the process of making a determination regarding potential RIF [reduction in force] notices unless and until September 30 passes without reauthorization.”
“I want to reassure you that I’m confident FDARA [the FDA Reauthorization Act] will be enacted and that these user fee programs will be reauthorized in a timely manner,” Gottlieb noted, adding that he’s been in regular communication with members of Congress who have expressed a “high degree of confidence that FDARA will be enacted before the authorizations lapse.”
Earlier this month, the House passed its reauthorization bill, and in May the Senate Committee on Health, Education, Labor & Pensions advanced a similar bill to the full Senate for consideration.
But, with the Republican effort to repeal and replace the Affordable Care Act taking center stage in Congress, Senate Majority Leader Mitch McConnell (R-KY) has yet to set a timetable for voting on the bill, though McConnell has delayed the start of the Senate’s August recess by two weeks to work on healthcare and other issues.
In an email to Regulatory Focus, a spokesperson for BIO said, “We are very pleased that the Commissioner has reassured FDA staff. We, too, look forward to the timely enactment of the user fee legislation, and we know that the House and Senate members are very aware of the dire consequences of not reauthorizing these crucial programs by the end of the current fiscal year.”
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email email@example.com for more information.
Image: Scott Gottlieb in front of Congress earlier this summer AP Images
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