- Speech by
Scott Gottlieb, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( May 2017 - April 2019 )
Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
FDA Science Forum
White Oak, MD
Since joining FDA earlier this month, I’ve had the opportunity to meet with many people here at the agency, including many FDA scientists
This is my third time at FDA. And I know from my prior work at the agency, that the expertise of our professional staff and the opportunities they have to apply their skills – and use cutting-edge science – is essential for maintaining the high quality of our work.
As FDA Commissioner, one of my highest priorities is to make sure that the FDA's work environment encourages creativity, efficiency, and superior science – and that we maintain an environment which attracts and retains top-quality scientists – an environment that enables scientists to do cutting-edge work as part of an effective team.
The work showcased during this forum is a foundational part of that commitment.
In the time since I last served at FDA, and for all the years I’ve followed the outstanding work that FDA does, I can tell you that I can’t think of a more rewarding time to be at the agency.
This owes to two reasons that bear directly on the state of science.
First, the challenges we face in promoting and protecting the public health. Many of these challenges, related to the growing diversity and sophistication of the products we regulate, are greater than ever.
Second, our ability to use tools of science to meet those public health challenges has also never been better.
The volume and complexity of activities for which FDA is charged with regulating has been increasing. There are more novel drugs and medical devices available to save and improve lives, and even more to come.
New technologies such as gene therapy and gene editing give us more opportunity to envision fundamental cures for a wider range of deadly and debilitating diseases. In the field of regenerative medicine, for example, FDA is currently formulating guidance that will advance standards to help the development of these products move forward.
At the same time, there are a growing number of more diverse food products than ever before, giving consumers more options to meet their needs. And we’re adding to these choices by importing a larger volume and greater diversity of foods than ever before.
These opportunities, many enabled by advances in science, are generally good things for all Americans.
But with the growing complexity of the products that we regulate –along with all the increasing promise – come novel risks.
With more sophisticated devices come risks to cybersecurity.
With novel platforms like gene therapy and gene editing, with tools like CRISPR, come certain new risks that are not typically associated with traditional small molecule drugs.
Similarly, gene editing of plants for human food provides new opportunities for innovation. But we also need to consider the most appropriate regulatory framework for these new commodities.
On top of these product-specific and scientific complexities to our work, we face certain broader societal challenges. First, we face many new challenges when it comes to safety for families: whether it’s the addiction to opioids and the abuse of opioid drugs, or the harms of tobacco, which now fall squarely within our public health mandate.
Second, FDA and all of us involved in public policy must do more to address health care costs without sacrificing the great potential of medical innovation. With exceptional medical treatments worth literally many billions of dollars in terms of better medical outcomes, have come concerns about rising health care spending and, in particular, the rising cost of prescription drugs. While FDA doesn’t play a direct role in drug prices, we all have a part to play in tackling these challenges.
In many of these cases, the new advances – and new risks – require us to reconsider and update the way FDA carries out our mission.
We’re here to implement the best possible approaches to reduce risks to the public and advance beneficial new innovations. This requires expert knowledge, creative thinking, and dedicated effort – day in and day out.
Above all else, it requires modern science to guide our work.
That science is happening right here at FDA.
For example, CDRH, in collaboration with members of academia and the device industry, are developing novel methods to create models of virtual patient outcomes. Leveraging prior clinical data, these models can be used to augment and, thereby, reduce the time and cost of future clinical trials. It can also improve efficiency. FDA, through CDRH, is now using this approach in a mock premarket submission review.
We’re also working toward having the science base to explore the potential to move current smokers – unable or unwilling to quit – onto less harmful products, if they can’t quit altogether.
Part of that important science base will emerge from a massive longitudinal study FDA is funding and overseeing known as the Population Assessment of Tobacco and Health, or PATH Study.
PATH will help us better understand how tobacco products that may pose less risk at an individual level are being used at a population level.
The agenda of this year’s Science Forum illustrates many other examples of how that modern science is guiding our work:
From progress in nanotechnology to 3D printing; to computational modeling and simulation that help support our evaluation of medical products; to the identification and development of new biomarkers; to genomic tools like the GenomeTrakr network, now used internationally to detect and trace foodborne illness.
FDA also recently signed a research and development agreement with Emulate to explore groundbreaking approaches for toxicity evaluation – using human organ systems in miniature, micro-engineered chips – to study the potentially harmful chemical and biological hazards in foods, dietary supplements, and cosmetics.
But, in order to keep pace with these advances and appropriately balance risk, FDA must continue to be an organization that keeps up with the rapid changes in the industries we regulate.
We must be an organization capable of developing and deploying effective, innovative, public health tools to guide our work.
The scientific work showcased here today is a foundational part of that commitment. So is the opportunity for scientific exchange with leading experts in our fields.
And so it’s in that spirit that it gives me great pleasure to introduce the keynote speaker for today’s forum: Dr. Eric S. Lander, the president and founding director of the Broad Institute of MIT and Harvard.
Dr. Lander is a famed geneticist, molecular biologist, and mathematician. He’s played a pioneering role in all aspects of the application of human genomics and was one of the principal leaders of the historic international Human Genome Project – a project that marked a watershed moment in modern science.
Dr. Lander has developed and applied methods for discovering the molecular basis of rare genetic diseases, common diseases, and cancer.
He’s done pioneering work on genetic variation, evolutionary forces, and methods to systematically identify the genes essential for biological processes, among many different disciplines and fields of study.
He’s one of the great scientific minds of our times, and it’s an honor to have him join us here today.
My FDA colleagues, I introduce to you Dr. Eric Lander.