It is a great pleasure to be with you today.  I’m sorry we can’t be together in person, but I am delighted to participate in this important event. 

I strongly believe that all of us in the scientific community as well as the business community and many others must help to support and stimulate girls’ interest in science, and make sure we provide meaningful opportunities for those who might not otherwise be encouraged to do so or have the chance to participate fully. 

This organization mission to remove systemic barriers to girls’ participation in STEM, while encouraging and engaging them in this type of learning is such an important goal, for a number of reasons.

The most obvious is simply that it’s the right thing to do, helping overcome an exclusionary and regressive approach to education, and preventing the development and growth of negative stereotypes. 

But there’s another reason to encourage opportunities for girls to engage in STEM, which is that it strengthens our scientific capacity and research generally, thereby helping improve the good of society. 

Who knows how many brilliant minds could be developing cures or new approaches to treat diseases if we just encouraged and supported them?  Who knows who the next Marie Curie, Francis Kelsey, or Susan Ellenberg will be? 

History is filled with far too many stories about girls whose curiosity for science (among other subjects and professions), was thwarted or undermined by someone who asserted that such a path was “inappropriate” for a girl.

As Francoise Barre, the eminent virologist and 2008 Nobel Prize winner in Physiology and Medicine, commented, “Certain people – men, of course – discouraged me, saying [science] was not a good career for women.” 

But, like so many women before and after her, Dr. Barre did not let that stand in her way.  In fact, as she explained, opposition to her career choice pushed her “even more to persevere."

I can personally appreciate some of the hurdles that many young women interested in the sciences face. 

Early in my education I knew that I loved science. But I didn’t come from a science background or a scientific family, and I was never particularly encouraged to take science or STEM courses.  In fact, at one point when I talked about going into science as a profession, my family suggested that I should probably just get married.

But when I was in high school, we won a state science competition and advanced to the national finals, which were held at Princeton that year.  I was overwhelmed by the school and the rigor of the scientific endeavor, and it helped fuel my passion for science.

So, in 12th grade, as I was looking at colleges, I went to my guidance counselor and said, “I want to go to Princeton.”  To which she responded something like, “What’s Princeton?” 

Needless to say, I didn’t go to Princeton.  But I went to Bucknell, where I studied chemistry, as well as doing many other things.  I then went on to medical school, and even continued my scientific training after that. 

But in fact, even when I interviewed for medical school, and of course this was a long time ago. But I did get a question from one of the interviewers, I did get the comment from one of the interviewers saying, “You’ll probably just get pregnant and have children, so why should we waste a slot on somebody who would follow that path.”  That was really the place things were for many years. 

But even though there were barriers, I had opportunities to follow my passion, and it was an important part of my development.  And certainly, if I hadn’t had those doors opened for me, I would have been the worse for it. 

Eventually, I ended up at the FDA, which, for a medical scientist, is really a dream job. 

I say that not just because I’ve had so many enriching and exciting opportunities there (or because I’m Acting Commissioner).  I say it because the FDA offers a virtual cornucopia of scientific possibilities to focus on. 

For example, today’s discussion is on COVID-19.  The FDA plays an important role in that response, which I’ll talk about momentarily.

But even as we respond to the current public health emergency, FDA staff have continued to meet our regular essential responsibilities to protect and promote public health, which are truly expansive and varied. 

To give you a quick idea of what this encompasses, the FDA ensures the safety, efficacy, and quality of all human and veterinary drugs, biological products, and medical devices, as well as of our nation’s blood supply.  We regulate cosmetics, dietary supplements, radiation-emitting products and tobacco products. And of course, the first initial in FDA stands for food; we oversee the safety of most foods, including the tracking and tracing of outbreaks of foodborne illness across the nation.

Additionally, the FDA helps to speed innovations that make medicines and devices safer and more effective. And we ensure the public has accurate, science-based information it needs to use medicines, devices, and foods to improve their health. 

What all this means is that FDA is responsible for overseeing approximately two trillion dollars annually in medical products, food, cosmetics, dietary supplements and tobacco. The products we regulate account for between 20-25 cents of every dollar spent on consumer goods in this country.

But how we do this is the second reason why the FDA can be a research scientist’s dream job.  That’s because nearly every aspect of work we do to advance consumer and patient safety relies on the need for strong data and the best available science.

Perhaps there’s no better example of the ways we work to gather and evaluate enormous amounts of data than in our response to the virus that causes COVID-19.  It involves a careful balancing of scientific innovation and the need to ensure the safety and efficacy of medical products.

What this can mean is that often are asked why we are we taking so long to approve something?  Or, by contrast, why did we approve something so fast? 

This focus on speed misunderstands that our analysis and decisions are based on a review of the data we have, and if we don’t have the necessary data, we have to make sure we get it. 

This process can be even more daunting during public health emergencies, which by their nature, demand faster responses and even greater innovation. 

During the current emergency, we have been challenged to the utmost by the need for new diagnostics, vaccines, and therapeutics.

We created a very successful action plan specifically focused on the development of treatments for COVID. 

In addition, we used the Emergency Use Authorization (commonly called EUA) to strengthen our response to the pandemic. As many of you may know, the EUA is a regulatory tool created by Congress after the 9/11 attacks.  It’s designed to enable rapid availability and use of medical countermeasures and lifesaving products, including vaccines, during public health emergencies. 

During this emergency we’ve issued more than 400 EUAs covering nearly 800 medical products, including diagnostic tests, PPE, and, of course, the authorization of three vaccines, including one that can be used in adolescents.

The EUA process is a good example of how we continually evaluate the best available data.  Even though the process for issuing an EUA for a vaccine is speedier than the formal approval process, the review is nonetheless supported by rigorous, scientific standards. 

The EUA is not the final step, however.  As you know, we recently approved the first COVID-19 vaccine. The FDA’s extensive review relied not only on the company’s comprehensive submission, but also involved the agency’s independent analyses of the data. And the vaccine also continues to be available under EUA for all of the populations for which it is authorized.

This work on vaccines is ongoing. 

So, while the COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, the available data suggests that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant.

The Biden administration announced a plan to begin offering additional doses of the vaccines, what has been called a booster shot, this fall to maximize vaccine-induced protection and prolong its durability.  These booster shots, if they come to pass, are subject to the FDA conducting an independent evaluation and determination of the safety and effectiveness of an additional dose of the Pfizer and Moderna COVID-19 vaccines.

Similarly, we are hoping to see the initial data that might support an EUA in the 5-11 year-old population by the end of September.  The company (Pfizer) has said publicly that’s when they intend to submit it.

When that comes in we’ll review the data as rapidly as possible and come to a decision.  I can’t stress enough how important it is that we evaluate the safety, effectiveness and dosing data for this age group from the clinical trials before administering the vaccine.  As we’ve learned time and again, these children are not just small adults and they may respond differently.

What this reinforces is that our review process is a meticulous one and a dynamic one.  We are constantly acquiring, reviewing, and evaluating data and expanding the evidence on which we base our decisions. 

It’s an approach we take in every area in which we have responsibility – whether evaobaluating a new medical product, tracking an outbreak of foodborne illness, or determining the safety of tobacco products, as we’ve been doing recently with e-cigarettes and newly deemed tobacco products.

All of which makes the work we do very challenging, very exciting, and very meaningful.  And it’s science-based. It’s why we want to encourage the best minds to join us.  And it’s why we need to support all who want to study STEM, especially those young women or others who might not think they are suited for it, or are discouraged by others from taking this path.

As Mae Jemison, the first African American woman astronaut in space said: “Don't let anyone rob you of your imagination, your creativity, or your curiosity.

It's your place in the world; it's your life. Go on and do all you can with it, and make it the life you want to live.”

I thank you for your attention today, and your commitment to this issue.