- Speech by
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )
Good evening. Thank you, Ellen [Sigal]
I’m delighted to be with you tonight for the Reagan-Udall Foundation’s presentation of its Innovations in Regulatory Science awards.
There is perhaps no organization better qualified to present these awards, which go to the heart of the kinds of work the FDA does to further our mission to protect and promote the public health.
The Reagan-Udall Foundation (or RUF) provides essential backing for that mission, by supporting the development and application of knowledge, tools, and methods necessary to address regulatory science challenges, and giving us a leg up in in ways that might not be possible for a government agency acting on its own.
I think it’s important to make clear at the outset what we mean by regulatory science.
At its most basic, of course, it is the combination of rigorous science and effective regulation. But regulatory science is far more than the sum of its parts.
Regulatory science is a discipline that supports and speeds innovation, and, specifically as it relates to the FDA, strengthens our regulatory decision-making processes and ensures they are modern, efficient, and supported by cutting-edge science and technology.
We live in an era of great scientific and medical promise, which creates enormous opportunities for new treatments and cures. We must stay current with these developments to help ensure the safe and effective development of new products for the patients and consumers who need them.
The Reagan Udall Foundation’s support helps us to do that.
You demonstrate this support in many different ways, from convening meetings of FDA’s stakeholders on key issues to collaborating on the development of individual initiatives.
For example, your support for the Innovation in Medical Evidence Development and Surveillance (IMEDS) initiative helps us leverage and expand the FDA Sentinel network for use by other stakeholders.
For those not familiar with Sentinel, it has been a gamechanger in strengthening our ability to monitor and track the safety of medical products on the market.
It has enabled us to more quickly and accurately identify issues like adverse events associated with new drugs, and it helps meet requirements for post-market surveillance and reporting.
The RUF also has played an important role in our work on the Expanded Access pathway, which provides access to an investigational drug or biological product to patients with serious or immediately life-threatening diseases or conditions.
Most recently, their support helped pave the way for the “Expanded Access eRequest,” which provides users with a streamlined and convenient experience when applying for expanded access for individual patients in non-emergency settings.
Quite simply, the FDA would not be as capable and resourceful an organization if it weren’t for the Reagan-Udall Foundation.
Today’s award ceremony is one more way the Foundation demonstrates its support for innovation in regulatory science, and shines a spotlight on the critical role regulatory science plays in addressing challenges in public health today.
And I can’t think of three more appropriate and deserving award recipients than the Foundation’s selections for this year’s honors.
The work being done by the Michael J. Fox Foundation for Parkinson’s Research is helping spur the development of new and better therapies and efforts to find a cure for Parkinson’s Disease.
By engaging patients and experts around the world, the Foundation is building a collaborative research environment, providing support and models for scientific research, and helping to educate policy makers and inform the public about these developments.
They are a true model of effective advocacy.
I’ve had the opportunity to work with this year’s recipient of the RUF’s innovation award, the Friends of Cancer Research, and its extraordinary director, Ellen Sigal.
As commissioner of FDA, and prior to that, in my work as a doctor who focused on researching and treating cancer, I’ve seen first-hand the important role that Friends of Cancer plays -- providing support to researchers, building collaboration with agencies like the FDA, and generating hope in patients in the search for new treatments and cures.
Their work to advance the use of Real World Evidence is just one way they accomplish this – but it represents one of the many ways they are helping strengthen clinical research, improve regulatory processes, and spur the development of new treatments for patients.
Last, but not least, it is with special pride and pleasure that I congratulate the recipient of the RUF’s leadership award.
Amy Abernethy is not just one of our own -- the FDA’s Principal Deputy Commissioner and Acting Chief Information Officer -- she is an impressive force for positive change.
Since she joined the FDA, Amy has helped lead and support the Agency’s work to develop better, more sophisticated, and more efficient ways to use and build data and technology solutions to strengthen patient care and enhance the development of new treatments and cures.
This innovative work is key to helping ensure we have the data and technology systems and tools we need to support our scientific work.
And she applies this focus to everything we do, with the overarching guide being how we can use it to learn from, and support patients. It has been my honor to work closely with such an outstanding public servant.
As I said, I can’t think of three more deserving winners of this award. This is particularly so coming as it does at a time when it is more important than ever that we support strong regulatory science that helps us speed innovation
During my tenure as Commissioner, I’ve seen how the FDA puts this into action in addressing its enormous breadth of responsibilities.
I’ve seen it in the way our scientists and regulators maintain our high standards of food safety and help ensure the security of our food supply, how they respond to health crises like the opioid epidemic, ensure our continuing oversight of tobacco products, (including e-cigarettes), and review and approve new medical devices, and approve safe and effective new drugs and biological products, to name just some of the areas of our oversight.
Perhaps most remarkably, however, I’ve seen how the commitment to these responsibilities has continued unabated in every center and office across the FDA, even as we deal with responding to the public health emergency posed by COVID-19 -- an effort that essentially has involved a doubling of our workload.
Since the beginning of the pandemic, the FDA has been working non-stop to help gain greater understanding of this virus, and it continues to be a primary focus of our work.
We are uniquely equipped with the necessary tools and resources to address this kind of challenge, from the Emergency Use Authorization, created by Congress after 9/11 to provide us with the ability to respond quickly during a public health emergency, to our application of the most rigorous science and best available data to each and every challenge we face.
We’ve successfully brought this ability to many different areas of our response to the pandemic – from the need for personal protective equipment, ventilators, and other essential medical devices and products; to our work to combat the sale of fraudulent COVID-related products; to our continuing support to develop therapeutic products and vaccines.
The good news is that we are making important scientific progress. Each day brings greater knowledge and new understanding of the novel virus, and with it increased promise of meaningful treatments and preventive measures that will keep us safer.
In recent weeks, we’ve seen some very promising developments. As you are aware, two manufacturers have submitted requests to the FDA to authorize the emergency use of COVID-19 vaccines that have completed stage 3 clinical trials. Others are moving through the pipeline.
I can’t speculate what will happen on this or any product that is submitted, as all the data are being reviewed by FDA’s career scientists. But I can say, with complete assurance, that they will receive the most careful scrutiny by our scientific experts.
While speed in reviewing these products is important, so is ensuring that any approved or authorized vaccine meets the Agency’s rigorous standards for safety and effectiveness. We will not authorize or approve any COVID-19 vaccine until such an approval or authorization meets the relevant statutory standard.
Additionally, we are committed to being as transparent as possible in order to promote public confidence in the FDA’s scientific review process and ensure that the authorized products are used appropriately.
One way to achieve this goal of transparency is by having the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) review vaccine applications submitted for authorization.
This advisory committee consists of external experts who provide non-binding recommendations to FDA related to data concerning the safety and effectiveness of vaccines and other biological products.
They currently have two meetings in open session scheduled – on December 10 and December 17 -- to discuss the requests for Emergency Use Authorization (EUA) of the Pfizer-BioNTech and Moderna COVID-19 vaccines, respectively.
We believe this transparency will help reassure the public regarding FDA’s commitment to ensuring that any FDA- authorized or licensed COVID0-19 vaccine meets its rigorous standards for quality, safety and efficacy.
This confidence in the work of the FDA is essential for any product we authorize or approve, but particularly so in the context of a national vaccination campaign for COVID-19.
We will no doubt face even more adversity before we can resume life as we once knew it. In the meantime, we must remain vigilant and safe in our response to this disease, and meet it with responsible behaviors and action that help keep us safe.
In addition, at the FDA, we will continue to apply what we have learned from the current crisis – to adapt and strengthen our approaches as needed, so that we can be as efficient and effective as possible.
I know that in this work, and in all the work we do, we can count on the continuing support of the Reagan Udall Foundation. And for that, we are grateful.
In that spirit, I am delighted to join with them today to celebrate the heroes of innovation in regulatory science they have chosen to honor today.