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Regulatory News | 25 July 2017 | By Michael Mezher
In an email to agency staff on Monday, FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after 30 September 2017, when the agency's current user fee agreements expire, if Congress has not passed legislation to reauthorize the agreements by then.
Previously, FDA has said it would need to begin issuing layoff notices to thousands of employees that are funded by user fees if the agreements are not enacted by 1 August, as agencies are typically required to give at least 60 days' notice to employees before a foreseen reduction in force (RIF).
In the email, Gottlieb says he's optimistic the Senate will take up user fee reauthorization soon and that the agency can "reasonably expect" the programs to be reauthorized before the 30 September deadline.
As such, Gottlieb says the agency does "not anticipate initiating the process of making a determination regarding potential RIF notices unless and until September 30 passes without reauthorization."
"I want to reassure you that I'm confident [the FDA Reauthorization Act] FDARA will be enacted and that these user fee programs will be reauthorized in a timely manner," Gottlieb said, 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 Focus, a spokesperson for the Biotechnology Innovation Organization (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."
Copy of Email
Tags: User Fee Reauthorization, Layoffs, Reduction in Force, RIF, Scott Gottlieb