FDA to Overhaul Hiring Process, Starting With PDUFA Vacancies

The agency’s current experts will play a role in recruiting new staff

The FDA’s new commissioner has announced plans to overhaul the agency’s hiring process, starting with a drive to recruit personnel to meet commitments under the Prescription Drug User Fee Act (PDUFA). “Too many of these positions remain vacant, and the backlog is substantial,” Scott Gottlieb, MD, said in an FDA Voice blog post.

Melanie Keller, head of the Office of Management in the FDA’s Center for Drug Evaluation and Research, will lead the new hiring effort on a full-time basis, with recruiting for PDUFA serving as a pilot program for the new hiring approach. Goals of the program include speeding recruitment and improving retention of scientific and technical experts.

The clinical expertise of the FDA’s staff is the key to fulfilling its public health mission, Dr. Gottlieb wrote. “As the products that we’re asked to review become more complex and specialized, so do the technical demands on our 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.”

The agency’s traditional approach to recruiting “is not as efficient as it should be,” he said. “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.”

Dr. Gottlieb expects to align hiring procedures with the scientific staffing objectives of agency programs. “We want to make sure that FDA’s existing experts are more personally involved in hiring our new experts,” he said. The agency 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.”

The new commissioner noted that Congressional legislation has given the FDA “the authority to bring on top candidates at competitive salaries.”

Source: FDA; July 17, 2017.