As the federal government continues with the rollout of its COVID-19 response and vaccination plans, the Food and Drug Administration somehow still lacks a permanent leader.
Nearly three months into his presidency, President Biden hasn’t yet nominated an individual to serve as commissioner for the agency – which, given the central role the FDA has been playing in the nation’s pandemic pushback, is puzzling at best and self-defeating at worst.
Even beyond the pandemic, any number of non-COVID-19-related issues are piling up on the agency’s plate, such as delays in Prescription Drug User Fee Act (PDUFA) dates to review new drug applications.
Oddly, the Biden administration doesn’t seem to be in a hurry to put forward a name for consideration. Still, many public-health experts and communicators believe the lack of a permanent commissioner isn’t helping the FDA define its priorities and direction at a time it’s sorely needed.
“It’s puzzling,” said Jon Bigelow, executive director of the Coalition for Healthcare Communication. “At a moment when the administration is making public health its number-one job, it’s strange to not have a permanent leader at the FDA.”
The delay could, in part, be related to the political debate over acting commissioner Dr. Janet Woodcock, who is considered Biden’s first choice for the permanent gig. Woodcock has a solid reputation in Congress and among pharma bigwigs, but concerns over her time at the Center for Drug Evaluation and Research, where she presided over the approval of opioids, prompt some critics to argue she bears some responsibility for the opioid epidemic.
As a result, four Democratic Senators (Joe Manchin of West Virginia, Catherine Cortez of Nevada, Ed Markey of Massachusetts and Maggie Hassan of New Hampshire) have publicly voiced their opposition to Woodcock. That pushback alone might be causing Biden to hesitate on pressing forward with her nomination until a few bigger bills, like the massive infrastructure package currently on the table, are passed, Bigelow said.
Other potential candidates for the full-time job aren’t as obvious. The list is said to include former FDA principal deputy Joshua Sharfstein and former FDA assistant commissioner for counterterrorism and emerging threats and acting chief scientist Luciana Borio. Former principal deputy and acting CIO Amy Abernethy was thought to be a candidate prior to her surprise resignation last month.
The delay, Pangea Policy founder Terry Haines pointed out, isn’t that unusual. He explained that it often takes months for a new administration to set up the government. On top of that, he added that “Biden is generally slow on nominees… The slowness has been well documented. In fairness, it takes a while.”
Still, it’s been a difficult two years for the agency since Scott Gottlieb departed in April 2019. Shortly after Stephen Hahn took office in December 2019, the COVID-19 pandemic hit.
Strong leadership may be needed now more than ever, given the agency’s wounded reputation. “The FDA needs a period to reinstate its position in public health, to settle down its staff and face a number of continuing challenges,” Bigelow said. “The news that the FDA recommended a pause in the J&J vaccine is another illustration of the issues the agency has to address, and another reason why it needs a visible leader with high public credibility at the White House and in Congress.”
As for the pressing issues facing the FDA, approvals of the Novavax and AstraZeneca COVID-19 vaccines rank on top of the list. General drug approvals are next in line, given the aforementioned issues around PDUFA deadlines.
Meanwhile, negotiations for the next PDUFA cycle are underway, and Bigelow believes the new permanent commissioner should contribute to the process. The FDA has also struggled to keep up with manufacturing facility inspections, a chronic concern exacerbated by the pandemic that experts have warned could lead to a supply-chain slowdown and issues with drug safety.
The FDA has cited COVID-19 as the reason behind many of these delays, but larger structural issues predate the pandemic.
“COVID-19 has been a factor in 2020, but the manufacturing backlog was high-risk back before COVID emerged,” Bigelow explained. “This problem built up over time, because the FDA has been chronically short-staffed. The lack of a leader as well as the stress on the organization have made it harder to hire people.”
To that point, some experts argue that the lack of a permanent commissioner is hardly the biggest problem facing the FDA – and that Woodcock’s permanent or acting status, or whether somebody else will run the agency, mean little in light of these vexing concerns.
“With Woodcock as acting commissioner, there is something of a safe holding pattern. It’s not like you don’t have anybody in charge or you have an acting person who doesn’t know what the agency does,” said Gillian Woollett, principal research scientist at healthcare consultancy Avalere. “To have a confirmed commissioner is a good thing, but the previous administration went through quite a few of them. Woodcock is providing a lot of consistency on classic operational things because she knows the agency inside and out.”
Indeed, the bigger picture is more important than the speed with which a permanent commissioner is chosen. Investing in the FDA so it can effectively tackle bigger structural issues, like expediting drug approvals and reemphasizing its scientific focus, will prove far more important, Woolett added.
“What’s going to be interesting to watch is whether we make a sufficient public health investment in the continuing COVID-19 pandemic and anticipate what’s needed for future outbreaks,” she explained. “The FDA is super important and has to be appropriately resourced. In addition to looking at the PDUFA fees, it’s important to consider ongoing appropriations in regards to the Centers for Disease Control and Prevention, the National Institutes of Health and the FDA.”
While a permanent commissioner might provide some needed stability, applying learnings from the COVID-19 vaccine development and approval process to future agency endeavors will be the real challenge.
“Even if we get through COVID-19 and we breathe a sigh of relief, a reckoning needs to happen around the FDA’s contingency planning,” Woollett said. “We need to process the lessons we learned to make the whole process more efficient for medicines in the future.”