Dr. Califf, I have deep admiration for your past and ongoing public service. The hard work of trying to protect the food and drug supply in the United States is a difficult and at times thankless task. The fact that you have taken this responsibility on more than once speaks volumes to your character.
Your decision post the infant formula scare and shortage in asking the Regan-Udall Foundation to take a critical look at the culture and structure of the FDA took a bit of confidence and a lot of courage. I had the honor to testify before your chosen panel and stayed to listen to the full two days of testimony from thought leaders – consumer, industry, academia and government – on how the “F” in FDA could best accomplish its mission.
Pulling from the panel’s recommendations, the FDA’s path to a safer food supply seems clear albeit a lot to “chew on”:
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.
My vision of a more empowered food-side of the FDA would have created two Senate appointed commissioners – one with a portfolio of all aspects of food as mentioned above and one with a portfolio of drugs and medical devices. However, I learned long ago to listen to those who swim in the deeper end of the intelligence pool. I think you agree with that. As you were recently quoted in an interview with the Washington Post:
In 2016, there was a deputy commissioner who was empowered. First, I was very comfortable with it. Secondly, it didn’t fix all the problems. There are still issues within that that need to be dealt with. We are coalescing on a plan. I had a deputy commissioner [when I was FDA Commissioner in 2016]. Scott Gottlieb [the next FDA Commissioner] changed that. If a commissioner comes in with grandiose ideas and gets halfway through a change, that’s not good for people. I think we are going to put in structures that are going to survive.
It seems that you, the Regan-Udall Foundation and the recently departed Frank Yiannas agree on the need for a revised structure within the FDA and the need for a person empowered to deliver and be accountable for creating “the safest food supply in the world”. As Mr. Yiannas recently said:
One, based on my experience these past four years, I (as well as a diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & Industry Stakeholder Groups) firmly believe the agency would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods. In this manner, she or he can more easily make the necessary changes that are needed to transform FDA’s Food Program for the 21st Century. Secondly, I also urge you to consider transferring the small, yet exceptional staff comprising the Office of Food Policy and Response (OFPR) to a new office of the Deputy Commissioner for Foods.
Dr. Califf, thank you for your leadership. The 48,000,000 who are sickened yearly by food they consume, the 125,000 hospitalized and the 3,000 that die are counting on you.
Dr. Califf, one final thought; lock the door and do not let Frank Yiannas leave the building.
Although I do not always agree with Mr. Yiannas on policy, the Regan-Udall Foundation’s definition of “ideal leadership” reads like a Frank Yiannas resume. The FDA needs someone with broad private sector experience who understands that the power of the FDA to effectuate positive food safety changes – including human nutrition – will come from both consumer and industry stakeholders – not exclusively within the present FDA structure.
When you make the FDA structural change, you need to have someone (Frank Yiannas) at your side. Do not let this moment pass. We all depend on you.