Regulatory Focus™ > News Articles > Update: Gottlieb Lays Out Plans to Bolster FDA's Staff

Update: Gottlieb Lays Out Plans to Bolster FDA's Staff

Posted 17 July 2017 | By Michael Mezher 

Update: Gottlieb Lays Out Plans to Bolster FDA's Staff

Editor's note: This article has been updated with the number of vacancies at CDER as of 8 July 2017.

Looking to fill a "substantial" number of job vacancies, the US Food and Drug Administration (FDA) will soon pilot new hiring and recruitment procedures for its drugs and biologics programs.

In a blog post Monday, FDA Commissioner Scott Gottlieb said the agency has struggled to keep pace with its staffing needs as it confronts increasingly complex and specialized products and strong competition from industry for recruiting top talent.

"The first order of business will be to address hiring into the positions supported by our [Prescription Drug User Fee Act] PDUFA commitments. Too many of these positions remain vacant, and the backlog is substantial," Gottlieb said, adding that the agency's "traditional approach to recruiting and hiring is not as efficient as it should be."

FDA spokesperson Jeremy Kahn told Focus via email that the Center for Drug Evaluation and Research (CDER) alone had 650 vacancies as of 8 July 2017, slightly less than the number it had in September 2016, despite the agency and Congress' efforts to improve hiring and retention.

According to Gottlieb, the pilot will look to modernize the agency's approach to hiring and more closely align with its scientific objectives and will be supported by a dedicated team of full-time staff led by Melanie Keller, who currently heads CDER's Office of Management.

While the 21st Century Cures Act passed by Congress late last year strengthened FDA's ability to recruit new staff by allowing the agency to offer more competitive salaries, the act's effect on hiring is still unclear.

It is also unclear how much of an effect President Donald Trump's hiring freeze had on FDA, as some positions within the Department of Health and Human Services were exempted from the hiring freeze, and as of late May Gottlieb said that FDA was no longer subject to it.

FDA's ability to keep well-staffed is a priority for the agency and industry alike. As part of the negotiations for PDUFA VI, FDA agreed to hire more than 200 new full-time equivalent positions from 2018-2022 and bring on a contractor to help out with its human resources needs.

However, if the user fee agreements are not reauthorized by 1 August 2017, FDA's workforce could suffer a significant blow as the agency would need to begin sending layoff warnings to thousands of employees.

FDA Voice

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