(Remarks as prepared for delivery)

Thank you, Susan [Winkler].  I want to express my great appreciation to the entire team at the Reagan-Udall Foundation for the time and energy you spent developing this report.  It’s clear you’ve given it a lot of thought and focus.  

I'll offer a few points about the report that I hope we can expand upon in our discussion.  In general, the report underscores several essential points about this troubling issue:  

•    First, the critical need for the public to have access to accurate medical and scientific information to help inform the decisions they make about their health; 

•    Second, the vital importance of the FDA’s communications role to deliver accurate, understandable, and timely health information, both to the public and to experts trusted by the public, especially clinicians, and the importance of expanding this work; and

•    Third, the understanding that this is an immense and very frustrating problem for which there is no one magic solution, that it is a challenge that must be addressed head on, in real time, and that it can only be effectively responded to through collaboration and teamwork within our own agency, throughout the government, and across the entire public health sector.

Let me begin with the report’s title, “Strategies for improving Public Understanding of FDA-Regulated products.” Implicit in this title is one of the most basic and essential roles of the FDA -- to provide and disseminate facts about science and medicine to the public in order to help Americans make informed decisions and choices about their health. That role is embedded in our mission statement, which says, in pertinent part, that the FDA will “help[] the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health”.  

It is a role we have embraced and attempted to cultivate for many years by using plain language and straightforward facts to communicate with the public in a variety of ways.

These include informing them about the safety of products and other consumer-based information, providing basic scientific factual information, filling gaps in the public’s knowledge, warning people about dangerous or deceptive products, giving them accurate nutritional information, and in many other ways to help make sure that medicines, foods, and other products are safe for consumers and patients and that the public has the information it needs to make health-related decisions.

This is not a small challenge, given the many scientists, clinical experts, lawyers and policy makers involved in our assessments and decisions.  Each of these disciplines take pride in the complexity and jargon involved in their work and translating it into plain talk is not natural.  We also have a high proportion of introverts in our workforce.  But it’s a fact that we have taken this seriously and we agree that we need to redouble our efforts.

The point is also well made that people trust their clinicians—doctors, nurses, pharmacists etc.   We have always communicated with these trusted intermediaries, but increased intensity of communication is needed.

Despite all of our efforts, we find ourselves facing an unprecedented challenge to our continuing ability to fulfill this important aspect of our mission. It is a change due in great part to the power of the Internet, the digitization of our world, and the preponderance of what is commonly referred to as social media. 

Make no mistake. I’m no Luddite who wants to return to the slide rule.  As someone who has spent a career focusing on the importance of having more and better data to inform our scientific conclusions, I’ve seen the power of technology for expanded health care opportunities, particularly to people who previously would not have had them.  I’ve seen how it has expanded opportunities for medical treatments and for generating and sharing reliable evidence.  It’s why we’ve worked hard at the FDA to adopt the most cutting edge technologies in our work. 

This report focuses on technological changes that have increased the ability of many to accumulate and share resources and to transcend previously existing boundaries, with few or no standards to guide them.  In the past, our voice at the FDA was considered authoritative and the communications ecosystem was relatively simple.  Now, we are one of many voices in a cacophony of information and opinions.  Exacerbating that impact is the fact that many of those voices are intent on diminishing or undermining our role.

There is certainly nothing wrong and plenty that is right with having more voices or increased opportunities for information.  Free speech is a foundation of our society.  

My concern comes when that speech poses an increased threat to public health, in great part because much of the information from many of these voices is unreliable or lacks scientific support and provides inaccurate and sometimes harmful information – misinformation – which can cause people to make plainly uninformed and adverse choices regarding their health.  Tuesday’s Washington Post has three articles on the decline in longevity and other health parameters in our country that draw the direct link between bad information, bad decisions, bad health and higher rates of death.

Many of those same voices also contribute directly to the longer-term undermining of trust in authoritative sources and experts, including the FDA and the erosion of scientific facts – disinformation, that is misinformation that causes harm.   

And yet, even as trust in the agency has dropped, at least partially as a result of these attacks, according to this report, the good news is that there remains both a strong foundation for building back that trust and a vital need to do so.  Let me offer one clear example from my field of expertise -- if there is such a thing as a simple example anymore.

In a recent Kaiser Family Foundation poll, 34% of Americans believed that Covid 19 vaccines have caused thousands of sudden deaths in otherwise healthy people.   I’ve spent my career studying sudden death and looked carefully at our post-marketing data—this is wrong and explains why people are hesitant to get vaccinated!  The fact is that those who are up to date on vaccinated are much less likely to die.

I’ll make one final point – and it’s a delicate one that goes to the very nature of how, whether, and when we can respond to the false claims and attacks on our work and activities.  

As the report accurately points out, misleading information, which tends to be more often sensational or emotional, often gets more attention than does straight factual information. It also tends to spread faster.  As Mark Twain wrote, "A lie travels around the globe while the truth Is still putting on Its shoes."

There's another related issue, which Is that the actions taken by the parties who are attacking and undermining our societal institutions like FDA can often prevent us from doing our job by putting limits on what we can say.   

So where do we go from here?  We must develop new and better ways to cut through and counter the misinformation and the disinformation so that we can meet our responsibilities and provide the public with the knowledge they need to make informed decisions about public health.  While this report is not an examination, per se, of the FDA’s work in this area, it does offer a number of options for us to build on what we are already doing to strengthen our response and help ensure that we continue to be a trusted, reliable voice that can cut through the noise.  

There are some who would say this problem is too big for us to respond to and that those who are committed to undermining science or diminishing trust in our government’s scientific institutions are too numerous and too well financed to overcome.  

I won’t deny this is an enormous challenge that can seem more perplexing at every turn.  It often feels like the Hydra, the mythical multi-headed serpent who would grow a new head every time one was chopped off.  

But it is essential that we try – not just for the work and reputation of the FDA, but for the very health of our nation.  

It will require enormous collaboration -- across our agency, and more broadly across the health care community.  This is a challenge that goes to the structural foundation of our society, and it is a job far too big for any one agency to take on.   

But respond we must.  As the writer George Moore said, “A winner is just a loser who tried one more time.”