In 2007, a Subcommittee on Science and Technology report found that “constrained resources and lack of adequate staff” was leaving the US Food and Drug Administration (FDA) unable to pursue “a culture of proactive regulatory science.”
The present day Commissioner Robert Califf was on the subcommittee, and during a fireside chat at BIO in San Francisco earlier this month he said that while the FDA responded well to the report, doubling in size since that time, there was still a lot of work to do to fill roles and retain talent.
“We now have 16,000 full time employees and 5,000 contractors. It’s a big place, and so if you think about start-up type growth in the midst of a federal government under great restraints, this is not an easy situation to deal with,” he told the room.
One of the major hurdles is the time it takes the Agency to hire staff, which Califf blamed on current HR systems and protocols.
“It’s been as much as nine months [to fill a role]. It’s coming down but there’s a lot of work to do. Imagine that you have 21,000 people and you’re trying to hire hundreds of people and everything’s done on paper in a federal system which has more requirements and checks and balances than you can imagine.”
Califf said since he began his tenure in February, the Agency has been revamping its internal HR systems. “They were antiquated frankly and there are things about the federal government that we can’t change because it’s built for hundreds of thousands of federal employees, not just for the FDA.
“But we’ve put in place an automated physician management system, we’ve focused on time to hiring as a key metric, we’re tracking a number of things and the system is beginning to move,” he said. “I won’t tell you it’s easy, but we’re very focused on this.”
According to the FDA’s FY 2017 budget request, submitted earlier this year before Califf was appointed, the Agency is looking to add as many as 3,800 additional staff across its headquarters alone.
Succession and knowledge management plan
Califf was also keen to ensure the FDA retains employee skills and information as part of a succession and knowledge management plan the Agency is looking into.
“How do you learn about some detail of what you need to know at the FDA? You actually have to go to a person to find that out,” he said, adding that in “today’s modern world that’s probably not the ideal way to do it.”
He continued: “What happens if that person gets hit by a bus, or decides to retire? A system of succession planning and a knowledge management system are our priorities because they go hand-in-hand.”