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Pink Sheet – US FDA Implementing Hybrid Work Policy In January

Pink Sheet – US FDA Implementing Hybrid Work Policy In January

The US Food and Drug Administration will not require all employees to resume their daily treks to the office going forward, choosing a “hybrid workplace model” that will go into effect in January 2023.

Commissioner Robert Califf made the change after the agency completed a six-month pilot exploring workplace flexibilities. The FDA said the new approach also “balances the needs of the people we serve and the industries we regulate, as well as the need for the FDA to recruit and retain the best talent.”

“This approach incorporates a range of on-site work, telework, and remote options in order to meet our public health mission,” an agency spokesperson told the Pink Sheet on 21 November. “It will be driven by the unique business needs of each center/office and the specific job duties of each position.”

The new workplace model will go into effect “once designations for each position in the organization are completed.”

“The FDA will be collecting metrics on this approach to regularly assess how well the model is working for the agency and our stakeholders,” the agency said. “The FDA will make adjustments along the way to adapt to the agency’s business needs.”

During the 17 November Friends of Cancer Research Annual Meeting, Califf remarked that plans were being finalized and that “no one I know is arguing that 100% of people should be there like the old days.”

“We’ll be looking at the hybrid environment much in step with what I saw in Silicon Valley,” Califf said. Several in the audience laughed after he added that the vision would not resemble that of Elon Musk, who instituted a number of changes and layoffs after purchasing Twitter.

The FDA, like much of the world, moved to full telework when the COVID-19 pandemic took hold in 2020. Agency work continued, although meetings were conducted virtually.

Most FDA employees were familiar with telework prior to the pandemic, in part because space constraints at the agency’s White Oak headquarters forced many to work remotely part of the time. Earlier this year, the agency decided to consider whether more widespread telework flexibility was feasible long-term.  (Also see “US FDA May Rethink White Oak Campus As Agency Plots ‘New Normal’ For Work” – Pink Sheet, 2 Jun, 2022.)

Workforce Needs Flexible Work Policy, Pazdur Says

As the pandemic eased, some FDA staff returned to the office on a regular basis and rules required others to work at White Oak at least one day per two-week pay period.

But Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said White Oak still appears “deserted” with more security guards than staff in the building.

“It makes no sense for us to go back to White Oak and then open up a computer and have a meeting on a computer when half the people are not there at White Oak,” he said. “We have to ask ourselves a question when we go back: What is the purpose of going back? It’s not just to go back to make an administrator happy or fill in a timeclock.”

Pazdur added that flexible policies are necessary now as most people work outside the “9 to 5” mentality.

“There’s been a seismic shift in the expectation of the workforce,” he said. “We’ve had this experience so it really has opened up I think a new way of working that is not only at the FDA, but is in industry and throughout really multiple industries.”

The Center for Biologics Evaluation and Research already is using its telework flexibility as a recruiting and retention tool. Retirements and departures could be averted because employees would not have to remain in the Washington D.C. area. At the same time, employees could be hired knowing they will not have to relocate.  (Also see “CBER Staffing Remains Challenging, But Permanent Virtual Work May Help Offset Expected Retirements” – Pink Sheet, 2 Jun, 2022.)

Will GOP Push Back On Telework Policy?

However, some Republicans in Congress are not happy with empty federal buildings and could use their upcoming majority in the House of Representatives to press for more in-person work.

Retiring Sen. Richard Burr, R-N.C., told Califf in September that now may be the wrong time to do a remote work demonstration project. Questions could arise during appropriations or other hearings about whether the teleworking policy is affecting performance and efficiency.  (Also see “FDA Staffing, Resource Gaps Makes Applying COVID Learnings To Other Disease Areas Challenging” – Pink Sheet, 14 Sep, 2022.)

Remote options also raise questions about ensuring employees are working all the hours for which they are paid. In addition, some believe requiring some in-office work with colleagues is beneficial.  (Also see “US FDA And The Lonely Return To The Office” – Pink Sheet, 20 Apr, 2022.)

Califf said during the FOCR meeting – he appeared in-person along with many audience members, but there was a virtual component as well – that in-person meetings will be allowed once again, but that virtual meetings will remain an option because they are more convenient in some cases.

The FDA recently resumed hybrid public meetings at White Oak, where speakers and/or audience members gather in the conference center with a remote option also available.  (Also see “In-Person US FDA Meetings Returning? Agency Will Support Those Events At HQ” – Pink Sheet, 3 Oct, 2022.)

The reauthorized prescription drug user fee program also adjusted the definition of sponsor meetings to indicate that virtual meetings were equivalent to face-to-face interactions. The change suggested that the FDA and sponsors wanted to maintain virtual meeting options after the pandemic.  (Also see “PDUFA VII Communications: Earlier PMR Talks, Formal Meeting Additions” – Pink Sheet, 24 Aug, 2021.)