I must admit I was a bit suspect when I flew from Seattle to DC a few months ago to testify for 5 minutes before the Independent Expert Panel. Putting aside if they would pay attention to me, but would the panel take to heart the experience and thoughtfulness of all the panels and the panel members. From a read of the report, I think they did. Now the question is will Congress and the FDA Commissioner take the recommendations to heart?
Here are a few highlights cut from the final report:
Most FDA employees understand the immense responsibility of the Agency’s Human Foods Program, appreciate the importance of their work, and share a common value of striving to protect public health. However, the current culture, structure, and governance model detract from the Program’s effectiveness.
There are several factors contributing to this culture, including the lack of a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and, when the situation requires, an ultimate decision-maker, who is responsible for the Human Foods Program. The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration.
The lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil…. As senior leaders are considered for the Human Foods Program, an ideal leadership skill set should include:
· Expertise and knowledge in food safety and/or nutrition
· Ability to make decisions in a complex regulatory environment
· Ability to lead in a complex work environment
· Strong demonstrated management capability
· Superb communication skills
· Ability to identify and nurture talent
· Commitment to collaboration, not isolation
· Capable of breaking down silos
· Proven abilities to lead, support, and incent teamwork
· Ability to support initiatives that increase staff professionalism and performance
· Commitment to joint staff development and other activities by the collective parts of the Human Foods Program
To move the Human Foods Program toward a more enabling and effective culture, the Panel recommends FDA leadership consider the following:
· Identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement for the Human Foods Program.
· Establish an organizational structure with a clear leader and ensure that there is a clear articulation of roles and responsibilities within the Human Foods Program and a culture that is well-equipped to survive (inevitable) leadership transitions.
· Develop and nurture a culture where regulatory decision-making is rooted in scientific evidence and FDA’s legal framework.
· Commit to transparency, timeliness, and predictability in decision-making, with a preference towards action.
· Commit to an on-going process of culture change from the highest levels of FDA leadership.
· Develop and implement a change management strategy that not only manages change, but also effectively improves and monitors the environment for cultural change.
· Build expectations and incentives into the system to embrace a positive, collaborative culture that expects, values, and rewards teamwork.
· Create a culture of feedback and authenticity where continuous, honest, and constructive feedback is given and received.
· Nurture current staff and recruit, hire, and promote top quality staff, including strong managers.
FDA should increase the visibility and prominence of the Human Foods Program.
Given the economic impact that foodborne illness and diet-related chronic disease have on Americans and the federal budget, it is imperative that the Human Foods Program become more prominent. When compared to the medical products programs within FDA, the Human Foods Program continuously struggles for visibility and prominence. A component of this elevation of the Human Foods Program is strong advocacy to advance the Human Foods Program at all levels of the government, especially at the Department of Health and Human Services (HHS) and the White House, including the Office of Management and Budget.
The Human Foods Program should have clear lines of authority.
Within the Human Foods Program, the importance of nutrition should be elevated.
The foods portfolio of ORA should be integrated directly with the other elements of FDA’s Human Foods Program.
The food-relevant work of CVM should be integrated with the overall FDA Human Foods Program.
A new Foods Advisory Committee, at the Commissioner-level, should be established to strengthen external input to Human Foods Program activities.
Structure changes should be implemented with cultural transformation efforts.
Honestly, this is what I focused on. I am convinced if you get the structure right and the right leaders in place, the culture will develop and the resources will be available. The Panel had five structural option. My preference is the first one:
The expectations of the FDA Human Foods Program and its impact on public health and our nation’s economy are immense. However, relatively modest increases in federal budget authority, flat staffing levels, and lack of sustained and sufficient commitment to upgrading information technology (IT)— contrasting with a rapidly changing food industry– have constricted the ability of the Human Foods Program to carry out its mission efficiently and effectively. In addition to aforementioned cultural and structural changes, the FDA’s Human Foods Program urgently needs additional personnel, financial, and IT resources to perform its Congressional mandate more effectively.
Here is the full report.