Key Takeaways
- HHS is allowing FDA reviewers to telework two days per week to “ensure continued productivity.”
- But the policy also requires divisions to maintain a presence at White Oak each day and attend sponsor meetings in person.
- The policy emerged as companies, advocates and investors detailed problems at the agency related to recent staffing cuts.
Application reviewers have regained teleworking privileges, but the limited scope of the order seems to have dampened the bit of positive news for the US Food and Drug Administration’s beleaguered workforce.
The Health and Human Services Department confirmed 10 April that reviewers are allowed to telework “to ensure continued productivity.”
But only review staff, which was defined as those “who are part of teams that review INDs and applications in accordance with user fee commitments,” may telework up to two days per week, according to an FDA memo obtained by the Pink Sheet.
“This opportunity is being offered to our review staff who are directly participating in activities that support review and approval of applications and are subject to performance review times under a user fee commitment,” the memo states.
The decision irritated other agency employees, who had petitions for teleworking privileges denied. One agency staffer who is not a reviewer said the move confirms the administration’s view that reviewers and inspectors are the only necessary employees at the FDA.
FDA staff returned to working full time at the agency’s White Oak headquarters in March. The lack of sufficient space forced some people to work in file or conference rooms or even on card tables placed in hallways. Parking and other problems also developed.
The 1 April reduction-in-force further culled the FDA workforce, which already had lost people to deferred resignations, early retirements, and buyouts. Application reviewers and facility inspectors were not cut, but staff working on regulatory policy, project managers and others who helped reviewers departed, which is expected to eventually hurt agency performance.
Employees Still Must Be In-Person For Sponsor Meetings
The memo indicated that teleworking options for those who qualified still were limited. Staff are expected to be “flexible and be in the office if needed for a sponsor meeting or critical team.”
“We should be willing to schedule meetings, especially with sponsors, five days a week with the expectation of in-person attendance for those assigned to White Oak,” the memo states. “This return to hybrid workplace will only be successful if we continue to perform and be available during work hours.”
Divisions also are expected to have some presence in the office each day.
“Teleworking on both Monday and Friday of the same week will not be an option,” the memo states.
The memo also reminded staff that telework is a privilege and “is not an accommodation for dependent/family care, e.g., child care and/or elder care during your scheduled telework days and work hours.”
Two telework days were allowed per week at the FDA, in part because of the limited space at White Oak, before the practice became popular during the COVID-19 pandemic.
As the pandemic began to fade, FDA officials used teleworking flexibility to attract talent. Full-time telework enabled the agency to retain employees who otherwise would have left and hire experts who did not live in the Washington, DC area.
When the pandemic ended, then FDA Commissioner Robert Califf implemented a hybrid policy, which allowed telework and on-site work. Hybrid formal meetings with sponsors also were allowed.
Letter Lists Examples Of FDA Problems Related To Cuts
The telework policy likely was implemented to help curb voluntary departures in addition to the layoffs and avoid missed user fee goals. But problems already are developing because of the loss of staff.
In a letter to Sen. Bill Cassidy, R-LA, who chairs the Senate Health, Education, Labor and Pensions Committee, biotech investors, patient advocates and others wrote that some companies are encountering “regulatory difficulties that we believe are the consequences of the FDA’s loss of experienced staff.”
The group listed several examples, such as delayed scheduling of routine meetings, which increased fears that the agency soon will begin missing approval decision deadlines.
Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say
“A California-based biotech now [is] engaging the European Medicines Agency earlier in development than previously anticipated to mitigate concerns about FDA’s ability to meet development timelines,” the letter, organized by the group No Patient Left Behind, states.
A Massachusetts-based biotech said its dispute resolution process was suspended “because their FDA counterpart wasn’t confident there would be any senior staff to review it.”
Former FDA Principal Deputy Commissioner Janet Woodcock called the cuts a “slow-moving catastrophe” that eventually will impact new drug approvals.
The letter also states companies are worried about the agency’s loss of experienced reviewers and senior staff. A company said it received reviewer feedback on a submission that “seemed to be from particularly inexperienced reviewers, contained suggestions that seemed inconsistent with medical practice or standard approaches to trials, contained several comments that were very poorly worded, and requested multiple things that were already clearly present in the submission.”
The letter requested the agency rehire employees “key to keeping the user fee program on track,” “key to capacity planning and workload analysis,” and “key to CDER/Office of Program and Strategic Analysis.” The group also wants the agency to “unfreeze the hiring freeze for roles that are critical.”
HHS Secretary Robert F. Kennedy Jr. said in an interview with CBS News that the layoffs were going as planned and reiterated they were meant to eliminate redundancy throughout the department.
“I want everybody at that agency to wake up every morning like I do and say, ‘What do I need to do today to make America healthy again,’ and to imbue them within and inspire them with that sense of mission,” Kennedy said. “We need to streamline the agency to do that.”
Kennedy also discussed the reasons behind delaying the approval of Novavax’s COVID-19 vaccine. (See sidebar.)
Several senior leaders at the FDA have left or been forced to leave since the Trump Administration took office. The most prominent was Center for Biologics Evaluation and Research Director Peter Marks, who resigned in late March rather than be fired.
Center for Drug Evaluation and Research Director Patrizia Cavazzoni retired prior to President Trump’s inauguration, and other senior officials departed in the following days and weeks.
