FDA, Workforce

After closing the gap on new hires, FDA could face an exodus of top regulators

The FDA is looking to strengthen its workforce using new authorities granted under the 21st Century Cures Act, according to a report sent to Congress earlier this month. And they’ll need all the help they can get.

After digging in and reducing the number of open jobs in the past year, FDA leaders say that 40% of senior execs will be eligible to retire next year — leaving the agency susceptible to a major top-level transition period at a time the hunt for top talent has never been more intense.

Scott Gottlieb

The Cures Act granted FDA the authority to streamline the hiring process for certain scientific, technical and professional positions, and allows the agency to provide higher salaries to ensure the agency can compete with industry and academia.

“This authority will allow us to better build and maintain the highly talented workforce needed to meet the challenges of today’s rapid advances in science, medicine, and technology,” FDA Commissioner Scott Gottlieb writes in the opening of the report.

According to Gottlieb, FDA has been using the human resources authorities granted under Cures since February 2018 but has “only begun to tap its potential.”

In the years leading up to Cures enactment, FDA struggled to fill hundreds of vacancies in its review divisions, often citing a drawn out hiring process and low salaries compared to industry as major hurdles in attracting new talent, especially in emerging scientific and technical areas.

However, within the last two years the number of vacancies at the Center for Drug Evaluation and Research has come down from more than 900 in May 2016 to 650 in July 2017.

Cures Implementation

Since Cures‘ passage in 2016, FDA says it has been working towards implementing its new hiring and HR authorities.

According to the agency, some of those efforts include creating a staffing team to identify candidates for “hard-to-fill” scientific positions, developing processes to reduce time to hire to less than 80 days and designing a new alternative pay structure for 38 occupations that is more competitive than under the agency’s earlier authorities.

FDA says it is still working on completing new policies and procedures around hiring but says that it made its first two hires using Cures authorities in early 2018 and expects to fill additional positions in the coming months.

Aside from salary levels and lengthy hiring times, FDA says that its swelling size has contributed to the challenge of filling open positions. In the last decade, FDA says its staff has more than doubled from 8,000 employees to approximately 17,000 today.

“The need to rapidly recruit highly skilled and experienced staff has been a challenge for the agency,” FDA writes.

Another major challenge FDA faces in maintaining its workforce is the sheer number of staff who will become eligible to retire in the coming years.

According to the report, staff turnover is currently around five percent each year, consistent with other federal agencies, but may soon spike as a growing number of staff become eligible for retirement.

As of 2017, FDA says that 13.3% of its staff are eligible to retire, and by 2019 the agency says that more than 40% of senior leadership will be eligible to retire.

In anticipation of the coming departures, FDA says it is working to develop succession planning strategies, though specific strategies have yet to be determined.

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information. 

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