A new start for the FDA?

By Jon Bigelow, Executive Director of the Coalition for Healthcare Communication

 “It’s déjà vu all over again,” as Yogi Berra famously said. Two years ago in this space, we wrote about a new FDA Commissioner chosen after a lengthy period of interim leadership. Unfortunately, things have not gone well for the Food and Drug Administration since then.

The COVID-19 pandemic erupted just three months into the tenure of Dr. Stephen Hahn; he never established his agenda, became mired in White House infighting and President Trump’s attacks, and lost credibility with delays in approving COVID-19 tests and his unsteady response to touted but unproven therapies. Since Dr. Hahn’s departure in January, there have been further controversies over the pace of authorizations for COVID-19 vaccines and backlash against the approval, with scanty evidence of efficacy, of Aduhelm for Alzheimer’s disease. Public confidence in the FDA suffered, as did agency morale, and several key leaders departed.

Now, President Biden has nominated Dr. Robert Califf, who served as Commissioner during the final year of the Obama administration, to return to the post. So, let’s try this again: What is ahead for the FDA?

Checking the boxes

The Commissioner sets the tone and priorities for an agency that regulates the pharmaceuticals and devices that power medical innovation, the nation’s food supply, and the tobacco and vaping industry. The FDA directly touches 20% of the U.S. economy; its drug approval and promotional regulation processes drive the work of everyone in healthcare marketing and communications.

A cardiologist and Professor of Medicine at Duke University, Dr. Califf has over 1,200 publications in the peer-reviewed literature, served as Vice Chancellor for Clinical and Translational Research, and founded the Duke Clinical Research Institute. After leaving the FDA in 2017, he serves as Head of Clinical Policy and Strategy at Verily, the life sciences firm spun off from Google.

Dr. Califf’s prior experience as Deputy Commissioner for Medical Products and Tobacco, and then as Commissioner, is important. Dr. Califf already knows the role, the FDA’s inner workings, and many of the staff, and he should be able to get up to speed quickly. His FDA service overlapped with the Cancer Moonshot Initiative championed by then-Vice President Biden, a helpful personal connection.

The road to confirmation

Confirmation hearings will be held both by the Senate Health, Education, Labor, and Pensions Committee and the Senate Finance Committee. At press time, these have not been scheduled, and are likely to be delayed until late December or January as the Senate grapples with the federal budget, the federal debt limit, the Build Back Better Act, and other priorities.

When he was nominated as Commissioner in 2016, Dr. Califf won confirmation by an impressive vote of 89-4, and 65 of the 89 Senators who voted Yes are still in office.

Although that arithmetic is encouraging, there are potential pitfalls:

  • The No votes last time came from Senators concerned about the FDA’s prior policies in approving opioid medications. During his tenure Dr. Califf conducted a review of the FDA’s opioid policies and outlined a new strategy. Nevertheless, as of press time, Sen. Joe Manchin (D-W.Va.) opposes Dr. Califf again and Sen. Richard Blumenthal (D-Conn.) has “very grave reservations.”
  • Bernie Sanders (I-Vt.) and others can be expected to grill Dr. Califf about his ties to biopharma companies. Not surprisingly, many of the clinical trials he participated in had biopharma funding. More controversial will be the biopharma stock holdings and board seats he has taken on since leaving the FDA; Dr. Califf has agreed to divest these holdings and recuse himself from certain decisions if he is confirmed.
  • Califf’s role at Verily may raise some questions about the privacy of patient data in clinical trials.
  • His tough stance against tobacco and vaping products may raise concerns for a couple of Senators.
  • And although last time Dr. Califf enjoyed bipartisan support, in today’s tribal environment some of the Republican Senators who previously voted for him could withhold their support this time around.

Once confirmed, what next?

The emergence of the omicron variant is only the latest challenge from COVID-19. The FDA is still setting policy and precedents as it considers authorizations and approvals for vaccines, boosters, and antivirals, and is under pressure to make decisions faster and to better coordinate messaging with the Centers for Disease Control and the White House.

The FDA also has a substantial backlog of manufacturing inspections delayed by the pandemic, affecting new drug approvals. The agency must decide how to evaluate several more potential therapies for Alzheimer’s disease in light of the Aduhelm precedent, and more broadly faces questions about the accelerated approval pathway and how it enforces mandated post-approval research. The FDA is behind schedule in decisions on a number of vaping products. The FDA remains short-staffed, and some key leaders are nearing retirement. Fortunately, to help address these various needs the FDA can tap off-budget funding from last winter’s American Rescue Plan and potentially the current Build Back Better Act.

Jon Bigelow

Priority One is likely to be the need to bolster the FDA’s internal morale and public credibility. The agency’s staff deserves more recognition for their dedication, and national leaders as well as average citizens have relatively little understanding of the complexities involved in clinical trials, drug approvals, and promotional regulation.

The brevity of his prior stint at the FDA limited his ability to make transformational change, but suggests a focus on greater use of real world data to supplement clinical trials, disparities in health outcomes, and reforming the FDA hiring process. As the keynote speaker at the Coalition for Healthcare Communication’s Rising Leaders Conference on Healthcare Policy in May 2017, Dr. Califf emphasized the importance of the FDA effectively communicating about innovations and safety issues not just to a narrow set of stakeholders, but to the entire American population. His passion and down-to-earth style were refreshing. The FDA is ready for a new start, and I sincerely hope that Dr. Califf will bring this same passion and style to his second term as Commissioner. Watch along with us at www.cohealthcom.org.