Strong FDA workforce for patients’ benefits, scientists invited to join

The new efforts the FDA is making will provide a solid foundation for recruitment and for responsibly managing our user fee resources, Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration said at the beginning of the week.

He said that the key to FDA’s public health mission, and its ability to bring innovative new therapies to patients, is the technical, scientific, and clinical expertise of its people. The products FDA reviews are becoming more complex and specialized, and that raises the technical demands on the FDA’s workforce. “Our staff must remain current with the dramatic advances in science and medicine and meet the increasing demands that globalization and other trends place on our core consumer protection functions,” said Gottlieb.

To answer the greater demands, the FDA continually faces the challenges related to building and maintaining a diverse, talented, and dedicated professional workforce, the commissioner pointed out. He said that the FDA is trying to maintain its image that attracts and preserves world-class talent.

Scott Gottlieb, M.D., the Commissioner of the U.S. Food and Drug Administration

“We know that our traditional approach to recruiting and hiring is not as efficient as it should be to attract, hire, and retain the types of experts we need now and anticipate to need over the longer term. What’s more, we’re increasingly competing with better-resourced entities in the private sector for the same limited pool of people with very specific clinical and scientific skills and training,” said Gottlieb.

“It’s critical that we modernize the process for recruiting personnel into these specialized positions within our Agency’s programs,” he said.

Melanie Keller’s role

As part of a new effort, and consistent with Secretary Price’s Reimagine HHS initiative, the FDA will be piloting new hiring procedures aimed at better supporting the hiring goals required to meet FDA’s evolving needs. Melanie Keller, currently head of the Office of Management in our Center for Drug Evaluation and Research, has agreed to lead this effort on a full-time basis. She’ll be running the pilot from a newly created position inside the Office of Medical Products and Tobacco, the commissioner pointed out.

According to Gottlieb, the central part of this new effort will involve more directly aligning the administrative hiring procedures and the scientific staffing objectives of our programs. Thus, the directors of the medical product centers participating in the pilot will be closely involved in overseeing the new initiative. They’ll help ensure that the scientific objectives of our review programs are more closely reflected in the recruitment and hiring process.

Gottlieb said: “We want to make sure that FDA’s existing experts are more personally involved in hiring our new experts. Although we face similar challenges across many of our programs, the pilot will initially focus on PDUFA- related positions in our drug and biologics programs while we develop our new model.”

To take on this new effort, Gottlieb pointed out that the FDA is 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. Professional staff from its 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 commissioner further said that the first order of business will be to address hiring into the positions supported by our PDUFA commitments. Even though that finding the right people and bringing them on staff quickly has proved difficult, the Agency’s goals will be to speed the hiring process while improving the retention of scientific and technical experts.

Scientists invited to join

The Agency will aim to reduce and eventually eliminate the backlog of vacant positions while demonstrating the utility of our new hiring model. The commissioner said he encourages scientific professionals and technical experts who wish to join an outstanding workforce serving the public health to review the available job opportunities at FDA.gov.

“I’m heartened by the progress FDA’s reauthorization legislation is making through Congress, and I look forward to its final passage. In the meantime, the new efforts I’ve outlined here will provide a solid foundation for recruitment and for responsibly managing our user fee resources,” Gottlieb said.

“The reauthorization, coupled with key provisions in the 21st Century Cures Act— which give FDA the authority to bring on top candidates at competitive salaries — will greatly assist us as we modernize our recruitment policies, systems, and procedures. All of these efforts will strengthen FDA’s core functions, enabling us to ensure that safe and effective advances can reach the patients who need them as efficiently as possible.” Gottlieb concluded.