(Remarks as prepared for delivery)

I’d like to thank everyone for joining us today to give input on a topic of importance to all of us - FDA’s use of and processes for advisory committees.

For over 50 years, FDA has relied on advisory committees for external advice from scientific, public health, and medical experts, as well as representatives of industry, consumers, and patients.

While our regulatory decisions are made by FDA career staff, our advisory committees are a vital resource in helping us as we evaluate complicated issues related to drugs, devices and other FDA regulated products, both before and after they go on the market.  Of note, the majority of the thousands of decisions the FDA makes every year do not go to an advisory committee; today we are discussing the issues and products with more complexity than the usual, a situation in which external advice is highly valuable.

But advisory committees don’t just advise on issues related to specific product applications, they can provide counsel on broader scientific, medical, and public health topics as well.

Before my time at FDA, I thoroughly enjoyed the opportunity to serve as a Special Government Employee, or SGE, on the FDA Cardiorenal Advisory Panel, the FDA Science Board's Subcommittee on Science and Technology along with some ad hoc SGE work with some of CDRH’s device advisory committees.  In many ways, the bringing together of complex data and information at an FDA advisory committee is an amazing component of our scientific enterprise.

Advisory committee meetings provide a unique window into the FDA’s work and into associated issues in use of technology and critical areas of medicine and health, and they can play a particularly important role in uncharted areas of public health. For example, during the Covid public health emergency, the Vaccine and Related Biological Products Advisory Committee provided valuable external advice that FDA carefully considered when making decisions about authorization of the Covid vaccines that played such a key role in countering the pandemic.

Our advisory committees play an important role in opening up the process and increasing transparency, and ensuring that the FDA hears from external voices, free to agree or disagree with FDA reviewers and leaders, as we make decisions and policies. 

We recognize that most people have a lot of things to think about other than the details of FDA advisory committees, but I remain hopeful that we can improve the understanding that advisory committees don’t make the decisions.  Rather our full-time civil servants make the decisions, as specified by law.  I also hope that disagreements in interpretation between our staff and advisors should not always be regarded as a negative.  If we always agreed, we wouldn’t need advice.  

While advisory committees are just that—advisory, many of you have heard me speak before about how important advisory committees are to the FDA’s work.  The Agency has frequently reconsidered ways to optimize our use of advisory committees, and I’ve been pleased to work with Dr. Bumpus on these efforts since she joined the Agency.  Our efforts out of the Commissioner’s Office have focused on finding ways to modernize and improve our systems, and to enhance the experience of Special Government Employees who serve the public as members.  While this infrastructure effort does not have the “glitz” of decisions about policies and products, a lot has been accomplished already in our systems, internal education, and attention to the needs of the SGEs who are so important to us.  A measure of our success will be if SGE’s spend less time on paperwork and more time digesting the complicated science, public health, and medical issues.  

As we work on process improvement, we wanted to be sure to give a forum to hear from the public about your experiences and ideas about advisory committees.  We are eager to hear from you today about these issues.  

As a physician, I know that the best care that leads to the best outcomes for patients is that which is grounded in solid scientific data, research, and expertise. This approach is equally applicable to FDA regulated products and public health issues at large. For this reason, it's equally important that FDA’s advisory committees involve a diversity of membership and experiences, to better understand the needs of our broad population.

There is an important related issue concerning the key role the FDA plays in communicating health information to the public.  I have been vocal about my concern that misinformation is a top threat to public health in America because of how it undermines not only the trust that the public has in the FDA, but in science itself. 

Addressing this issue goes beyond simply publishing accurate information. It involves clear, consistent communication, sound science and sound policy, as well as open dialogue involving the FDA, experts in the topic areas we are addressing and the broader public. 

Environments that open the dialogue and allow a broad array of people to witness how we and outside advisors examine the data and evidence underlying our decisions, and the consideration of experts, provide an avenue to build public trust and confidence in decisions.  An important element of this discourse is discussion of the uncertainties as study designs, interpretation of the needs of consumers and patients, and data analyses are dissected in the course of advisory committee discussions.  I believe that this is an area where a lot of work is needed—having differences of opinion as a part of science rather than using differences to undermine confidence in science.

FDA’s advisory committees include committee members from a wide variety of backgrounds, often including patient or consumer representatives, whose role is to provide a voice for those most impacted by our decisions. 

The public can also submit comments through the public docket or by speaking at the open public hearing portion of advisory committee meetings. 

As our advances in science and technology continue to expand, and the opportunities for new treatments and approaches grows, it is increasingly important for the public to be aware of and understand the work of advisory committees and how that work is factored into the FDA’s decision-making. This will enhance the understanding of emerging products and issues that affect them, demonstrate that it is valuable to voice concerns, recommendations, and feedback, and, if we get it right, increase their trust in the process. 

I am eager to hear your suggestions for the composition of our advisory committees, how we can improve the public’s understanding of advisory committees, and overall, how we can optimize the advisory committee process. 

It is my hope that with your input, we can make our advisory committees stronger than ever.

Thank you for your participation.  At this point, I am pleased to turn the microphone over to our Principal Deputy Commissioner, Namandjé N. Bumpus, for additional remarks.
 

 

Remarks by Dr. Bumpus

Thank you, Dr. Califf, for that insight on the importance of advisory committees and thank you all for joining us today. 

As Dr. Califf said, the FDA relies on advisory committees composed of outside experts who evaluate data to provide advice on scientific, technical, and policy questions and share their perspectives on patient and consumer experience issues, to help the FDA make decisions based on the best science available. 

The FDA has 32 advisory committees, one of which has 18 panels, and 2 subcommittees that cover the full range of products and public health issues that fall under the FDA’s regulatory authority.
The types of advice that FDA asks of individual advisory committees can vary. For example, the FDA might ask for an advisory committee to provide feedback on the nuances of data interpretation; the clinical importance of possible benefits, risks, or toxicities of interventions; or product safety and effectiveness.

The topics FDA takes to advisory committees are often intricate. The committees’ consideration might include assessment of multiple co-related outcomes such as the relationship between clinical applications and product development or ethical considerations and emergency use.

Because of the complex nature of their work, it is important that advisory committees are composed of the right experts for the topic, and that administrative burdens for the SGEs are addressed to the extent possible.

Over time, we have received a lot of feedback on our advisory committee process, from their composition to their role in advising FDA. 

Because of this, we have made it a priority to evaluate our advisory committee process and to explore ways to optimize their use.  While the Agency regularly receives input about advisory committees from some specific groups, we would like to hear more broadly from all parties interested in the advisory committee process and how it can inform FDA’s decisions.

As part of this ongoing effort, we have convened this listening session to hear directly from you all on the composition, public perception and overall experience of advisory committees and their members.

I am delighted that we have over 50 speakers sharing their perspectives today and I am confident that this dialogue will provide an important and a useful step forward in our continuing effort to optimize our advisory committee process.