Gottlieb Moves to Overcome Hundreds of Scientific Vacancies

With hundreds of key vacancies to fill at FDA, commissioner Scott Gottlieb has ordered a “comprehensive” review of the agency’s hiring practices and procedures. “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,” he says in an online post. “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. These are challenges that our current approach to hiring did not anticipate. It’s critical that we modernize the process for recruiting personnel into these specialized positions within our agency’s programs.”

Gottlieb says the agency will soon begin pilot testing new hiring procedures aimed at better supporting the hiring goals required to meet FDA’s evolving needs. CDER Office of Management director Melanie Keller has agreed to lead this effort on a full-time basis inside the Office of Medical Products and Tobacco, he says.

“A central part of this new effort will involve more directly aligning the administrative hiring procedures and the scientific staffing objectives of our programs,” Gottlieb’s post explains. “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. 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.”

Additionally, Gottleib says a dedicated group of full-time staff will help with hiring critical scientific staff. “The first order of business will be to address hiring into the positions supported by our PDUFA commitments,” he says. “Too many of these positions remain vacant, and the backlog is substantial. Finding the right people and bringing them on staff quickly has proved difficult. Our goals will be to speed the hiring process while improving the retention of scientific and technical experts. We’ll aim to reduce and eventually eliminate the backlog of vacant positions while demonstrating the utility of our new hiring model.”