FDA Commissioner Highlights Staffing Priorities

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-20-2017 12:06


The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb highlighted the staffing priorities at the agency and how the agency plans to fill more scientifically advanced and technical positions. He made his comments in a July 17, 2017 post on the FDA blog site, FDA Voice.

 “As the products that we’re asked to review become more complex and specialized, so do the technical demands on our workforce,” he said in the post. “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.”

To that end, Gottlieb has requested a comprehensive effort to evaluate the FDA’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. 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.”

As part of a new effort and consistent with the US Secretary of Health and Human Services Tom Price’s Reimagine HHS initiative, which is designed to optimize department operations, Gottlieb said that the FDA will be piloting new hiring procedures aimed at better supporting the hiring goals required to meet the FDA’s evolving needs.

Melanie Keller, currently head of the Office of Management in the Center for Drug Evaluation and Research, has agreed to lead this effort on a full-time basis. She will be running the pilot from a newly created position inside the Office of Medical Products and Tobacco.

Gottlieb said that a central part of this new effort will involve more directly aligning the administrative hiring procedures and the scientific staffing objectives of FDA programs. He explained that the directors of the medical product centers participating in the pilot will be closely involved in overseeing the new initiative to help ensure that the scientific objectives of the agency’s review programs are more closely reflected in the recruitment and hiring process. The pilot will initially focus on Prescription Drug User Fee Act (PDUFA)-related positions in the agency's drug and biologics programs while it develops its new model.

To take on this new effort, the FDA is establishing a dedicated group of full-time staff with the responsibility to ensure that the agency identifies, recruits, and hires the scientific personnel it needs. Professional staff from the centers with experience recruiting specialized scientific and medical staffing will be 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 first order of business will be to address hiring into the positions supported by the agency’s PDUFA commitments. “Too many of these positions remain vacant, and the backlog is substantial,” said Gottlieb. Its goal is to reduce and eventually eliminate the backlog of vacant positions while demonstrating the utility of the agency’s new hiring model.

Source: FDA


Thank you for reading DCAT Value Chain Insights (VCI), an information resource from the
Drug, Chemical & Associated Technologies Association (DCAT). 

Learn more and sign up to receive a complimentary subscription