FDA Investigator Attrition Rate Addressed at 2024 PDA/FDA Conference

At the PDA/FDA Joint Regulatory Conference 2024 held in Washington, DC, September 9-11 2024, Associate Commissioner of Regulatory Affairs (ACRA) in the FDA Office of Regulatory Affairs (ORA), Michael Rogers discussed his office – which will be renamed Office of Inspections and Investigations on October 1 – and the attrition FDA has been experiencing in its investigator staff recently.

“One of the things that I am focused on is investing in our most important resource to address what I see as a very high attrition rate within the agency,” Rogers told the audience.

“I know that there is a significant cost to the agency when we lose a trained investigator. And I remind people, our center director and colleagues and my boss, the commissioner and others in the external stakeholder community, that so much cannot happen in the FDA without the work that we do every day on the front lines. That is a fact.”

A former FDA investigator himself, Rogers commented, “I know how hard that job is.” He outlined some of the agency’s possible efforts to retain current investigators and attract new hires:

• Pay challenges: “Investing in our workforce, we want to broaden the use of Title XXI that has some pay band advantages.”
• Travel challenges: “We are looking at ways to improve the travel experience, domestic travel and foreign travel, which can be difficult.”
• Investigator training and recruiting: “We also want to take a new approach to training. We need to modernize our training, not only in-house, but leveraging public-private partnerships, working with our centers, looking at new modalities.”
  • Regarding external training, Rogers shared that he is “the architect for a course, an introduction to public health food inspections, the first ever of its kind. It is available now at North Carolina State University. It is giving instruction to individuals with a science background about investigations and inspections, and what regulators do to assess whether the regulated company is in compliance. The goal is to expand that to other areas, other universities, and have a cross-programmatic focus.
  • “These individuals get instruction on FDA law and what it takes to assess a manufacturing operation against standards. They will also be told about things I didn’t know when I joined the agency. I did not know that I would travel all over the world and how rewarding the job can be. We want to expand that to other areas, and we hope that is going to be a pipeline for investigators to join the FDA.”

There was discussion at the conference about remote regulatory assessments and other ways to assess facility compliance – for example, collecting samples at the border, looking at recalls or market withdrawals, and leveraging information from foreign governments, all of which help the agency understand the regulatory picture.

“But,” Rogers emphasized, “I can tell you that inspections will always be part of our regulatory strategy. As a former investigator, nothing takes the place of our ability to use all five senses to assess whether a firm is in compliance. That is the narrative that we need to introduce into the conversation, especially with those who make decisions about our budget.”

For additional reporting on the FDA restructuring, including org charts, see this RAPS post.