- Speech by
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )
Good afternoon. It’s a pleasure to be back with you again, albeit virtually.
The work that this organization does – in terms of the support you provide to researchers, the collaborative support you give to agencies like the FDA, and the hope that you give to patients – is profound.
As someone who has spent my life immersed in researching and treating cancer, I know just how valuable your efforts are in the search for developing new treatments and cures.
As you’re well aware, we’ve been engaged in responding to the public health emergency triggered by the SARS-CoV-2 virus for more than eight months now.
While we continue to make progress in our understanding of this disease, our work is nowhere near done. We must continue our collaborative efforts to help contain the spread and to find new treatments and vaccines.
When I spoke to this group just a few months ago, I outlined some of the developments in our ongoing efforts to counter the virus and to support the development of a vaccine.
We are making important progress, and the FDA continues to provide the essential regulatory advice, guidance, and technical assistance needed to respond to this disease.
In my brief remarks today, I want to underscore that even as we’ve been working around the clock to take on the extraordinary challenges of responding to the pandemic -- with what has represented an approximate doubling of our workload -- our centers and offices have continued to maintain the Agency’s regular mission-critical responsibilities.
Some good news on this front is that, through the CURES pathway established by Congress, we’ve been able to increase hiring over the past year. For FY 20, the FDA hired 2,308 staff (and lost 1,281) with a total net gain of 1,027, compared to a FY19 net gain of 135.
We have also made significant progress with the percentage of CURES hires from outside the agency, as 54 percent of our Cures hires have been external. This represents an important achievement for the agency especially at a time when our focus has rightfully been on the global pandemic.
It’s meant we’re better equipped to maintain our high standards of food safety, continue to approve safe and effective new drugs and biological products, approving and clearing important medical devices, and, of course, continuing our oversight of tobacco products, including e-cigarettes.
When I last spoke with you in September, we had just hit an important milestone related to tobacco – the premarket review submission deadline.
This ensures that new tobacco products, including many already on the market, undergo a robust scientific evaluation by the Agency to determine, for example, whether marketing the product is appropriate for the protection of the public health.
We still have a lot to do in this area, particularly to counter the alarming increase in the number of youth who are using e-cigarettes. We remain committed to this work. We will continue to take enforcement action against companies who target or market e-cigarettes to kids. And we will maintain a major investment in public education campaigns to dispel any misperceptions held by young people that e-cigarettes contain just harmless water vapor.
Our work in the cancer space also continues full force, offering great promise. You’ll hear a good deal about some of this work shortly, from the head of our Oncology Center of Excellence, Dr. Pazdur, but I wanted to highlight just a few exciting developments, including some of this work that has been related to COVID-19.
For instance, we are studying closely whether, as some reports have indicated, patients with cancer have worse outcomes than others with COVID-19.
One way we’re gathering these (and other) data is with the COVID-19 Evidence Accelerator, run by the Reagan-Udall Foundation and Friends of Cancer Research.
Among other research activities, the Accelerator community is applying real world data to help characterize the natural history of patients with cancer and COVID-19, including long term sequelae, thereby strengthening our science-based response to this unprecedented public health emergency.
We are also leveraging our research-based collaborative agreements with several main real-world data companies to support rapid characterization of COVID-19 incidence in cancer populations, as well as its impact on treatment and outcomes.
And we are continuing to address the impact the pandemic has had, and will likely continue to have, on the conduct of clinical trials of medical products, from quarantines, infections of participants, site closures, travel limitations, or interruptions to the supply chain for the investigational product.
We are studying and supporting sponsors and trial sites in their work addressing these challenges. For instance, we released the “FDA Guidance on the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” and have updated the guidance several times to address inquiries received from stakeholders. In addition, we established a central email box for sponsors and investigators to send inquiries regarding clinical trial conduct and have responded to over 500 inquiries to date.
Meanwhile, we continue full speed ahead on our non-COVID cancer-related work, including important drug approvals.
For instance, as of October 30, CDER had approved 42 novel drugs, including 15 new drugs to treat patients with various forms of cancer.
Several of these approvals have been “firsts” for oncology, including:
The first FDA-approved therapy, Tabrecta (capmatinib), to treat non-small cell lung cancer with specific mutations; Retevmo (selpercatinib), the first therapy approved specifically for lung and thyroid cancer patients with the RET gene alterations; and
Tazverik (tazemetostat), the first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer that often occurs in young adults.
And this is just a small sampling.
As this group well understands, for decades we’ve seen a significant shift in the direction oncology has been heading, ever since the discovery of hormone-receptor status in breast cancer. Increasingly, rather than necessitating separate development programs for each disease site, these types of approvals are irrespective of organ site or histology.
Sponsors may need to focus on both drug and biomarker development to pursue site-agnostic indications. And multiple sponsors may be pursuing the same site-agnostic indication as well as developing a companion diagnostic test. We encourage sponsors to work collaboratively on biomarker and companion diagnostic development.
Work and research in the cancer field continues to be promising, helping to shape and inform so many other types of medical research and to spur the development of new and creative treatments across medicine.
It’s in large part thanks to your work and commitment that we are able to realize much of this potential.
In closing, let me just once again thank the Friends of Cancer Research for everything you do to support patients and innovation, for your partnership with the FDA, and for your support of our public health mission.