Highlighting Major Issues Critical to FDA

Across Our Diverse Agency After One Year Back

By Robert M. Califf, M.D., Commissioner of Food and Drugs, FDA
Twitter: @US_FDA

Recently I marked my one-year anniversary as the 25th Commissioner for Food and Drugs. I have been proud to represent the U.S. Food and Drug Administration and its talented and hard-working staff in these extraordinary times. So much has been accomplished despite the enormous workload and societal forces that make the mission more challenging than in other times. While I could cite myriad achievements from the work the agency has accomplished on specific projects over 2022 and many more in the queue for 2023, to give you a sense on my priorities, I’d like to highlight major “cross-cutting” issues that are critical for the FDA as an institution across our diverse agency.

These are indeed extraordinary times. The FDA is always in the public eye because the decisions that we make impact so many people every day. But we are now fully into an era in which the vast majority of people have access to the internet, either through increasing availability of high-speed service or the ubiquitous ownership of cell phones. The combination of the COVID-19 pandemic and the rise of misinformation purveyors on this vast new communication landscape have led to substantial societal mistrust in our society’s institutions, including the FDA. On the other hand, if you turn on the television or social media, you readily see the power and value of the FDA’s approval or clearance—both advertisers and newscasters refer to “FDA approval” as an important stamp of quality of a product. We are fortunate to work in an arena with such an important societal impact, and I’m very lucky to be the leader for a second stint. The agency needs to use this power wisely and with humility.

Human Foods Program

The infant formula recall happened on the day I was confirmed, and food has been my major focus since then. During my confirmation I heard from many people indicating that there was internal and external agreement that the Human Foods Program needed more attention and support. Armed with the Food Safety Modernization Act and the “New Era of Food Safety” documents, the Solomon report on infant formula and the Henney-Reagan Udall Foundation report on the Human Foods Program, by the turn of the new year we had all we needed to initiate planning for a transformational change. Enormous forces are impacting the food industry: climate change and international disruptions of supply chains; immense potential benefits (and potential risks) of biotechnology, including genome editing; “big data” opportunities to redefine the impact and regulation of toxins in food; continued improvement in our understanding of nutrition; and scientific and technological innovation. We have a chance to design a food program that will support the constructive evolution of the industry to a period of plentiful, nutritious, and safe food for the U.S. and the world.

Office of Regulatory Affairs

Supporting the work of the FDA’s Office of Regulatory Affairs (ORA) will be central not only to the success of the recently proposed Human Foods Program, but also to moving all of the FDA into the model for future regulation. I can’t stress enough my belief that optimizing our work is not simply a matter of drawing new boxes for the organization. The ongoing work of the Implementation and Change Management Group is to look at the workflow and identify approaches that will support the functions of ORA and provide first rate technology to make the work more efficient, effective and rewarding for our stellar workforce.

Center for Tobacco Products

2022 also marked the retirement of Mitch Zeller from the FDA’s Center for Tobacco Products (CTP). Mitch is an icon of the field. Fortunately, we were successful in recruiting Brian King to lead CTP from a field of highly qualified candidates. CTP is in its “teen age years” compared with other FDA centers, and it faces daunting issues with the continued enormous mortality and morbidity from combustible tobacco as the industry is shifting to vaping as its future market. The difficulty of dealing with millions of applications for products and the complexity of enforcement were addressed in the Silvis-Reagan Udall Foundation report. Our responses will be posted shortly. With major proposals to eliminate flavored combustible tobacco products and to reduce nicotine in cigarettes being considered and developed, we have a chance to play a major role in dramatically reducing the almost 500,000 deaths per year in our country from tobacco as we move CTP into “young adulthood.”

User Fees

The successful reauthorization of the user fees for the medical products was a tremendous achievement, locking in critical funding for five years. The Omnibus included important legislation like an extension of hiring authority beyond medical products, improving the accelerated approval pathway, and bringing cosmetics regulation into the modern era. Now we have a lot of work to do to make the legislation work for the American people and for our own workforce, and to see across the finish line key legislation that was left behind at the end of last year. And, of course we have ADUFA and AGDUFA up for authorization this year.

COVID-19 Pandemic

I can’t think about the past year without recognizing the remarkable management by agency staff of so many issues with the ongoing COVID-19 pandemic. Thanks to their hard work in conjunction with all sectors, Americans have plenty of tests, effective vaccines, antivirals and ample other devices and medical supplies and intact supply chains for food. Time after time they have made critical decisions without all of the information to weigh risk and benefit that we have in normal times—in the midst of a pandemic we have to use our best judgement based on the data and information available, and they have done that well. In the oversight hearing of February 8th, I was able to defend our staff’s excellent, hard work with no hesitation. But the pandemic is not over despite the planned ending of the public health emergency under the Public Health Service Act—we all have a lot of work to do to guide the industries we regulate into usual order in a way that sustains health and confidence in the system.

Hybrid Work Environment

An outgrowth of the pandemic was the realization that the FDA could construct a hybrid work environment, optimized for productivity and lifestyle. Looking forward, it’s not so much about COVID-19. Instead, the hybrid work environment is the best way to optimize the “balanced scorecard” that defines our work: productivity, employee satisfaction, constituent satisfaction, and cost. As we move into the next era, fine tuning the approach should enable us to optimize these factors for each individual and group in a way that was not possible before the pandemic caused us to explore new options.

Misinformation

I strongly believe that misinformation is a leading cause of preventable death in America now. While, of course, this cannot be proved, the situation with COVID-19 is instructive. Most of the COVID-19 deaths since vaccines and antivirals became available were preventable if people had gotten updated on their vaccination status and, if high risk and infected, had they been treated with an authorized antiviral. In the “good old days” snake oil salespeople had limited reach—now they can reach a billion people in 10 minutes. The impact of this evolving information environment goes well beyond COVID-19 into everyday decisions that Americans make about their health. We will be working on a strategy to fulfill our stated mission of “helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health” in the face of a tsunami of confusing and misleading information. A Reagan-Udall Foundation project will be helping us explore this issue this year.

This article was originally published on FDA Voices and is reprinted here with permission.