By Nancy Bradish Myers, Catalyst Healthcare Consulting, Inc.
President Biden and his leadership team have taken great pains to put in place a diverse and talented set of leaders across the federal government, and the effort should be applauded. Now, it is the FDA’s turn.
With the crossing of 100th day in office mark, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the myriad challenges caused by the pandemic and its aftermath.
Case in point is the CDC’s recent wading into the role of analyzing vaccine safety data and communicating it to physicians, which are primarily FDA’s responsibilities. The effort was so misaligned that former FDA Commissioner Scott Gottlieb felt it necessary to pen an op-ed in the Wall Street Journal highlighting and drawing lines around the FDA’s jurisdiction. Without a permanent commissioner in place, the FDA wasn’t in a position to push back.
Too Much At Stake
The agency is at a crossroads: It needs a commissioner who can not only skillfully lead as the agency continues to address the challenges of a pandemic but who also has the capability to gently and deftly implement reforms, including the efficiency and workforce lessons learned from COVID, in order to start pivoting to a post-pandemic FDA.
As a long-time FDA watcher and FDA alumnus, it is very clear to me that now is not the time to install a well-intentioned outsider as commissioner. A sign stating “Novices Need Not Apply” should be affixed to the commissioner’s office door at White Oak. Too much is as stake and the moving parts of the job are too intricate for a leader who will need on-the-job training.
Just on the medical products side of FDA’s responsibilities, consider the challenges around conducting timely and rigorous reviews for COVID vaccines and treatments while also closely monitoring for unexpected safety signals from products available under Emergency Use Authorizations. A commissioner simultaneously is going to need to show leadership and stepped-up coordination with international regulatory authorities and find safe ways to overcome manufacturing snafus.
Meanwhile, the agency must diligently work to tackle pandemic-induced slowdowns in facility inspections and non-COVID product reviews, which in some centers are significant.
Other essential tasks include implementing new IT infrastructure and integrating learnings from both the unintended silver linings and occasional missteps of the full-bore COVID effort.
This colossal and complex agenda, which includes medical products, food, animal health, cosmetics, over the counter products, tobacco, and much more, calls for permanent leadership as quickly as possible -- with an FDA leader who can hit the ground running and, with careful but expeditious steps, skillfully lead the agency through the storm with knowledge, confidence, and resolve.
There are many possible landmines along this path, and the FDA needs a leader who has the knowledge and experience to recognize and management skills to address them.
One risk perhaps underappreciated by the White House is the possible chilling effect on staff morale and retention that may accompany inexperienced leadership.
The FDA staff has been working at full throttle to address the COVID crisis under political circumstances that put FDA’s gold-standard reputation into question, and their understandable fatigue and frustration is bubbling to the surface. Installing a novice with limited management experience and/or awareness of unique pressures of working at FDA risks a mass exodus of highly trained and in-demand personnel that would set the agency back for years.
The Candidate Qualified To Take On Challenges Ahead
FDA will be best served by a commissioner who on day one possesses qualifications including:
- Deep knowledge of the nuances of FDA policy, law, and process, including the technical and scientific issues the agency faces.
- Significant experience managing a large government agency like FDA and an understanding of its budget and user fee negotiation agreements.
- A track record that has earned the respect of a proud but weary FDA workforce and a readiness to deal with the challenging needs of a staff returning after over a year of working at home while also recruiting new top talent.
- Ability to communicate credibly and accurately about highly technical issues to various audiences in order to win the public trust.
- Experience working collaboratively and in a bipartisan manner with Capitol Hill, and the capability to represent the agency effectively at Congressional hearings with fluent knowledge of FDA policy, programs, and history.
- A vision for FDA that recognizes opportunities to innovate regulatory frameworks without undermining the gold standard reputation of the agency.
- Established relationships with foreign regulators so the agency can rapidly address and formulate solutions to global supply chain, policy, and intellectual property issues, including pressing matters related to the pandemic.
- Compliance with FDA’s strict conflict of interest requirements, which preclude investments in areas of FDA’s very broad portfolio.
It is clear few professionals can meet these criteria.
Although I am biased because I worked for her at FDA, I do have one suggestion: Acting Commissioner Dr. Janet Woodcock.
Dr. Woodcock has established relationships with the key players in FDA’s orbit and has garnered respect of politicians, scientists, patient advocates, international regulators, and the agency workforce. She has proven herself to be a nonpartisan workhorse who has earned accolades from both sides of the aisle over the years. Her tenure would not be an entry on the resume of somebody on the way to the next job but the capstone of a 37-year career dedicated to advancing the mission of the agency. In many ways, she’s FDA’s Anthony Fauci, whom the president has praised for his 40-year government career and called “trusted, a truth teller, a patriot.”
Side-Stepping Politics And Considering Totality Of The Evidence
It appeared not long ago that Woodcock would be named permanent commissioner. But it’s now unclear whether the administration is willing to go the mat for her nomination -- even though a wide range of stakeholders continue to push hard for her appointment, including patient and research groups with which Biden has long relationships stemming from his Cancer Moonshot initiative when he served as vice president.
The politics of Senate confirmation appear to be a factor standing in the way of her nomination.
One of the reasons Woodcock’s candidacy is in the crosshairs is that a few politically important Democratic senators believe that as the director of the Center for Drug Evaluation and Research, she allowed numerous powerful opioids to enter the U.S. market and was not quick enough to use her regulatory power to help halt the opioid crisis once it was identified.
The drugs approved by FDA proved to be extremely addictive and were over prescribed both knowingly and unknowingly and ruined many, many lives. It is a tragedy, and in retrospect most agree that FDA could have and should have done better. Every policymaker to a person, especially those at FDA, would likely love a “do over” -- but that is impossible. FDA could have handled things better, but looking back, I don’t think Woodcock’s role is disqualifying for the commissioner job.
As with all careers, I would hope the administration and senators involved in a confirmation process would take the totality of the person’s experience into consideration when making a decision as important as who would best serve and manage FDA during a pandemic. Woodcock has been the driving force behind much of the innovative regulatory thinking at the agency over nearly four decades.
So, there’s an obvious political attraction for the administration in putting forth a shiny-penny nominee who lacks a longstanding track record of FDA-related opinions and actions that could risk complicating the confirmation process. Someone with little FDA experience will have the luxury of offering politically expedient, vague, and collaborative responses to Senators’ questions and could provide the short-term benefit of a smooth, speedy, and uncontroversial confirmation.
In addition, some names recently floated as trial balloon candidates may also satisfy important administration stakeholder constituencies with interests in specific policy topics.
But this is not the time to take the path of least resistance.
FDA’s critical action list is too long and too consequential to play politics or to use to appease a specific constituency. If we bear in mind Dr. Stephen Hahn’s recent rollercoaster tenure as commissioner, it becomes clear that the public health will be best served by side-stepping the temptation to nominate a novice, despite being professionally accomplished and well-intentioned, and place a career agency leader and expert in the FDA top job, especially in the midst of a pandemic.
And looking forward, FDA would benefit from having a leader with firsthand experience of missteps, and the depth of knowledge and experience to set agency policies and take actions to mitigate against their happening again. Management experience is power, and it engenders confidence from a skilled and committed career staff. We can’t afford to have a commissioner so new to the agency that he or she is unaware that with FDA, there always is a potential crisis lurking around the corner.
As the search proceeds, it is my hope that the White House and Senate remain mindful of the stakes at hand. We need a leader who understands from day one the work required to find the answers to challenges FDA faces in fulfilling its public health mission, not someone who will need time and on-the-job training to even identify them.
And so, we wait.
About The Author:
Nancy Bradish Myers, JD, founder and CEO of Catalyst Healthcare Consulting, Inc., is a Washington, D.C.-based attorney with deep expertise in healthcare law and regulation, policy development, patient engagement, and government relations. She served as senior policy counsel in the Office of the FDA Commissioner, as well as special assistant/senior strategic advisor to the FDA acting deputy commissioner for operations. Myers has been closely involved in drug, biotechnology, and medtech regulatory issues for over 25 years. She currently advises cutting-edge clients on regulatory and health policy matters. You can reach her at email@example.com or connect with her on LinkedIn.