We recently reported on the Senate’s passage of the FDA Reauthorization Act (FDARA) which renews and enhances the FDA drug, medical-device, biosimilar, and generic-drug user-fee provisions. Without these fees, FDA was expected to issue employee layoffs, but FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any layoff notices to user fee-funded staff “unless and until September 30 had passed without reauthorization.” We now have an interesting story that outlines how the FDA plans to build—rather than layoff—its talent pool.
FDA Recruiting Talent
According to the Endpoint News article, Gottlieb is fielding a new team of recruiters to start scouting top talent for the agency. It is being reported that the Commissioner is rolling out a pilot program to start a talent hunt, looking to better match new hires with the many jobs they have open. And the agency plans to start by recruiting new staffers for the PDUFA-related positions in the drugs and biologics programs.
“To take on this new effort, we’re establishing a dedicated group of full-time staff with the responsibility to ensure that we reliably and predictably identify, recruit, and efficiently hire the scientific personnel the Agency needs,” noted Gottlieb in a recent FDA blog post.
“Professional staff from our centers with experience recruiting specialized scientific and medical staffing will be key members of this new pilot effort. Staff from the Office of Operations will assist with the identification of potential candidates from key scientific disciplines.”
The article further outlines that Gottlieb has asked CDER’s Melanie Keller to take charge of the initiate. She’ll be running the pilot from a newly-created position inside the Office of Medical Products and Tobacco.
Drug Development and Industry Support
The article notes that the agency has been plagued by hundreds of positions long left open at the agency, making recruitment a key issue for Gottlieb. His plan to accelerate a wave of new drugs to the market will be hampered by a lack of regulators to help clear the backlog of generic applications. Better expertise will also help Gottlieb adopt new technologies to more quickly and efficiently promote drug development.
The article concludes by noting the popularity of this within the biotechnology industry, so it should be an interesting development to follow in the coming year.