Dr. Hahn's Remarks to the Reagan Udall Foundation Annual Meeting October 13, 2020

Speech | Virtual

• Speech by: Stephen M. Hahn, M.D. ; Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )

(Remarks as prepared for delivery)

It is my great pleasure to be able to join all of you today and provide you a brief summary of some of the FDA’s recent work. 

I want to begin by expressing my appreciation for the Reagan-Udall Foundation and its support of the FDA. 

I share with you, the commitment to the agency's mission and responsibilities, and particularly its emphasis on data driven decision-making and regulation. 

All of which makes my appreciation for your role with the agency that much greater.

The support you provide allows the FDA to advance its vital mission in ways that probably would otherwise not be possible for a government agency to do on its own.   Your help in developing and applying knowledge, tools, and methods necessary to address regulatory science challenges are just a few examples of your support.

This is especially important at a time of profound scientific advances and the opportunities they create. 

It is essential for the FDA to stay ahead of these developments.  In this way we are able to make the most informed regulatory decisions. 

The evidence of your engagement is everywhere.

It’s evident in the meetings and other ways you bring together FDA’s stakeholders on key issues.

It’s evident in the support you’ve provided to help us advance specific initiatives, such as Innovation in Medical Evidence Development and Surveillance (IMEDS), which helps us leverage and expand the FDA Sentinel network for use by other stakeholders.

Few projects I can think of that have had more of an impact on our ability to help ensure track the safety of products than Sentinel. 

It has vastly speeded up our monitoring ability, and allowed us to more quickly and accurately identify issues like drug-associated adverse events, and to help meet post-market surveillance and reporting requirements.

Your support and insight also is evident in our work on the Expanded Access pathway, which provides patients with serious or immediately life-threatening diseases or conditions access to an investigational drug or biological product. 

You’ve helped in the development of the expanded access Navigator website and database, which provides patients and their health care providers with information about how to access investigational treatments outside of clinical trials.

And most recently, your support helped pave the way for the “Expanded Access eRequest,” which provides users a streamlined and convenient experience when applying for expanded access for individual patients in non-emergency settings.

And this is just scratching the surface. 

What your consistent and targeted support reinforces is that you understand the value and importance of the FDA, particularly in our world today as we face the challenges posed not just by the COVID-19 pandemic, but by a host of other public health challenges that the FDA is uniquely prepared to address.

Last week, I spoke to the Food and Drug Law Institute (FDLI) annual conference.  Some call it the “State of the FDA” speech. 

And, as I said there, it is quite easy to summarize what the state of the FDA is.  Very … busy.  Very, very busy in fact.  But, also very productive.  And, as always, we remain committed to, and successful in fulfilling our mission to protect and promote the health and safety of the American public.

The primary reason we continue to be successful in that mission – even in the face of a public health crisis like the one we are engaged in now – is due to something you all at the Reagan Udall Foundation know very well. 

And that is the professionalism, knowledge, and commitment to its public health mission that the 17,000-plus employees of the FDA bring to their jobs every day. 

Since day one on the job, I’ve relied on the hard work and support of the amazing FDA staff.

And throughout this pandemic, I’ve seen this staff immersed in a round-the-clock, multi-faceted, accelerated response to COVID-19 -- an effort that essentially has involved a doubling of the workload. 

But I’ve also seen, in the face of this incredible challenge, how our centers and offices continued to fulfill the Agency’s mission-critical responsibilities in every center and office across the FDA.

I’ll give you just a few recent highlights. 

For instance, at a time when we’ve faced temporary shortages as a result of food supply chain issues, we have worked with our partners at CDC and OSHA to help employees and employers in affected food industries continue operations safely, AND we’ve been able to advance a number of important new food safety initiatives. 

In July, Frank Yiannas and I announced the release of the New Era of Smarter Food Safety Blueprint, which outlines the steps the FDA will take over the next decade to create a more digital, traceable and safer food system -- to minimize the impact of foodborne illness in this country by reducing the number of illnesses.

Through this plan, we will be leveraging new and emerging technologies and modern tools and approaches to build on the work we’ve done and continue to do through implementation of the FDA Food Safety Modernization Act (FSMA).

The challenges of the pandemic have only clarified that our New Era goals will strengthen how we approach the safety and security of the nation’s food supply.

Another important milestone occurred earlier this year, with the release of the 2020 Leafy Greens STEC Action plan to outline a collaborative, action-oriented approach to enhancing the safety of leafy greens.

We also launched two education campaigns, one to raise consumer awareness of the New Nutrition Facts label and another called “Feed Your Mind” – in partnership with the U.S. Department of Agriculture and the EPA -- to provide science-based information on genetically engineered foods, commonly called GMOs.

Thanks to the efforts of our Center for Tobacco Policy in effectively regulating a complex and rapidly changing tobacco landscape, we marked an important milestone in our efforts to respond to the alarming increase in the use of e-cigarettes among our youth. 

The health implications of nicotine addiction and combustible tobacco use are clear.  And, further, we know that young people who experiment with e-cigarettes are more likely to try combustible cigarettes.

September 9th was the premarket review submission deadline, when manufacturers of deemed, new tobacco products – including many currently on the market – submitted their premarket applications to FDA.  The Agency has received some criticism over the delay of this deadline and I am proud of Mitch Zeller and the staff of CTP who enabled FDA to reach this important public health achievement.

Deemed products are now in line with the cigarettes and smokeless tobacco products already subject to premarket review under the statute. The FDA will conduct a robust scientific review to determine if a new tobacco product meets the criteria for receiving FDA authorization.

Also on September 9th the data from the 2020 National Youth Tobacco Survey (NYTS) was published in partnership with the CDC demonstrating an overall decline in youth e-cigarette use with about 1.8 million fewer U.S. youth currently using e-cigarettes (compared to last year). 

Despite the positive news, there is much work to be done as 3.6 million youth are still current users of e-cigarettes. I made a promise when I was confirmed of my commitment to protect America’s youth and now I pledge that the FDA will continue this important work.

I also want to highlight the great work of our Office of Operations, which has forged a strong strategic partnership with Senior Leadership of the Agency to substantially increase hiring. 

This issue has received a lot of attention and some criticism since the establishment of the CURES pathway for hiring was established by Congress in 2016.   I am happy to report that for FY 20, the FDA hired 2,308 staff (and lost 1,281) with a total net gain of 1,027, compared to our FY19 net gain of +135. 

We have also made significant progress with the percentage of CURES hires from outside the agency, as 54 of our Cures hires have been external.  And I’ll offer one more number as evidence of this progress – the agency this year has reached a new high total number of 18,261 on board federal employees.  This represents an important achievement for the agency especially at a time when our focus has rightfully been on the global pandemic. 

We also continue to use a variety of tools to conduct inspections and enforce our regulations. 

In July, the Agency began working to resume prioritized domestic inspections, after announcing in March at the start of the pandemic, that we would be temporarily postponing all domestic and foreign routine surveillance facility inspections.  This was done to protect the safety or our employees.

We are expanding our working relationship with the US Postal Service, and other agencies, and planned the establishment of satellite laboratory operations at selected International Mail Facilities (or IMFs), bringing scientists with special training and advanced tools for rapid testing to these points of entry.

We soon expect to sign an MOU with U.S. Customs and Border Protection and U.S. Immigration and Customs Enforcement, in collaboration with other Homeland Security agencies that will allow our agencies to maximize inspections, investigations, and detection capabilities.

Our medical product centers have been especially focused on addressing the challenges of the pandemic, supporting the development of safe and effective medical countermeasures, from ensuring that our front-line health care workers had and will continue to have the necessary protective equipment, to providing essential regulatory advice, guidance, and technical assistance to advance the development of tests, therapies, and vaccines.

For example, our Center for Devices and Radiological Health (CDRH) has, as of last month, issued more than 525 Emergency Use Authorizations (EUAs), which is more than ten times the number authorized in all prior national emergencies combined. 

I know I don’t need to explain to this audience that the diagnostic tests, PPE, infusion pumps, ventilators, and other devices authorized under these EUAs have been instrumental in the public health response.

Of course, these centers have continued to meet the broader demands of the nation related to non-COVID medical products. 

To give you one example, as of September 8, CDER had approved 40 novel drugs, addressing a wide variety of illnesses. including 15 new drugs to treat patients with various forms of cancer.

And sixty percent (24) of these new drugs will help patients with rare diseases.

We have also continued our pace on generic drugs.  As of July 31, 2020, we have approved more than 400 generic drugs, including 38 first generics.

And CBER also has continued to apply its expertise and embrace its many different responsibilities, from helping to ensure the safety of the blood supply to the review and approval of new biological products.

I also want to point out that we have maintained a similar pace of meeting our goals on review of applications for medical products during the pandemic that we have maintained in recent years.

For instance, in FY20, we met most of our user fee goals for drugs by taking timely action on at least 90 percent of brand, generic, and biosimilar drug applications, even during the pandemic.

As you know, congressionally authorized user fees provide resources to enhance the efficiency of the review process.  We continue to take our responsibility to fulfill our user fee commitments very seriously.

This brief sampling shows how the American public can always depend on the hard work of the FDA.

And that’s especially important right now as we face the continuing challenges of the COVID-19 pandemic and the search for therapeutics and vaccines.

I’m sure you’ll have a number of questions about this topic, but before we open it up, I just want to say a couple things. 

We are moving as quickly as possible to support the development of these products.

Of course, our work on COVID-19 and non-COVID issue comes with unprecedented public scrutiny.  And sometimes criticism.  Any agency that has the broad responsibilities and impact of the FDA, particularly involving issues of public health, can’t expect to do its job without inviting controversy and disagreement. 

But it’s also essential that the criticism we get never shakes the underlying faith the public has – and should have – in the FDA and our commitment to protecting public health.  I am confident in the decisions that are being made related to COVID-19 and that will be made as we continue to address these challenges. 

I know there has been particular attention paid to a few of the decisions reached by FDA scientists over the past several months.  I want to assure you that every one of them has been made by career FDA scientists based on science and data, not by politics.

FDA represents science in action.  Often, we must make real-time decisions based on ever evolving data concerning a previously unknown, highly contagious virus that we are still learning about even today.

And sometimes it is necessary to change or reverse decisions as new data emerge.  This is inherent in the Emergency Use Authorization (EUA) process and is akin to how a doctor might approach a patient in an emergency situation, constantly updating a treatment plan as new data emerge.

It is essential for a national vaccination campaign is to be successful that the American public understand and have full trust in the FDA’s review process.

I want to assure them, and you, that the FDA will not authorize or approve any COVID-19 vaccine before it has met the Agency’s rigorous expectations for safety and effectiveness.

Every one of the decisions we have reached and that will be made have been and will be made by FDA career scientists based on science and data, not politics.

Finally, I want to note that we are regularly reviewing our responses to the pandemic and applying the lessons learned to both current and future challenges.

For instance, on clinical trials, COVID necessitated changes to the way clinical trials were being conducted across medical product areas, and we look forward to studying closely the results to identify those modified procedures that might be beneficial to implement in clinical trials more broadly.

The COVID-19 Evidence Accelerator, run by the Reagan-Udall Foundation and Friends of Cancer Research—with robust participation from FDA—has become a great example of how a large group of stakeholders can come together to advance the science of RWD and its use in responding to the pandemic.

Finally, you’ve already heard from Drs. Shah and Abernethy, about the COVID-19 Pandemic Recovery and Preparedness Plan (or PREPP), which focuses on identifying avenues for improvement by coordinating scientific leadership, agency operations, communications, and programming across the agency for all regulated products.  

This is an essential aspect of the FDA’s work.  We don’t operate in a vacuum and aren’t simply reactive.  It’s important that we have a plan in place – as we did for this public health emergency – to apply what we are learning now, so that can be stronger in combatting the next emergency.

I know we can continue to count on the support and guidance of the Reagan Udall Foundation’s in our efforts to address the continuing challenges we face, and I very much look forward to working with you.

Let me again thank you and all the members of your organization for the terrific work you do.