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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the Award Ceremony for Dr. Frances Kelsey

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Award Ceremony for Dr. Frances Kelsey
September 15, 2010

What an extraordinary series of reflections on the life and work of Dr. Frances Kelsey. There is no doubt that she was—and is—a remarkable women, with so many stories to tell. We are so grateful that she is with us today and so very much more grateful that her career path brought her to the FDA in the first place. Like for many of us, it was not a predetermined path.

I’m told that when Frances Kelsey completed her undergraduate degree in pharmacology in 1934, as a woman looking for work in the midst of the depression, she realized she had two choices: enter graduate school or join the bread line. “Those were about the only alternative in those days,” Dr. Kelsey recently told one of our FDA historians. “I decided graduate work would be more interesting.”

She looked for a program in biochemistry, wanting to study the “conductor of the endocrine orchestra,” the pituitary gland. But when that department was full, she found a professor in the pharmacology department working on the posterior pituitary. Though it was considered unglamorous stepchild the gland back then, Dr. Kelsey could see the potential of her research and decided to pursue it. And, as we are all aware, that wasn’t the last time her foresight paid off.

But before she could make the decision that would etch her name in the history books forever, Dr. Kelsey, then Frances Oldham, continued her studies. Some time after she earned her master’s degree, she applied for a research assistantship position and PhD at the University of Chicago. And she was accepted. And as always, she broke new paths.

One thing bothered her about the acceptance letter. It began, “Dear MISTER Oldham.” She wondered then: should she write and explain that Frances with an “e” is female and Francis with an “I” is male? And she wondered later: “if my name had been Elizabeth or Mary Jane,” would “I have gotten that first big step up?” Sadly, I don’t know…

But we can certainly agree today that we’re all extremely lucky she did.

After finishing her PhD, attending medical school, and working as a practicing physician, Dr. Kelsey arrived at the FDA as a medical officer and reviewer of new drug applications—a job that took advantage of both her pharmacological training and her medical degree…a rare combination in the Bureau of Medicine.

She applied her knowledge and intellect to the tasks before her. As you all well know, she was given the job to review the drug thalidomide. She took that responsibility seriously, and she questioned what she saw. She scrutinized the data that came before her and all that she could find outside. She didn’t settle for glib or easy answers.

The rest is history. And history makes clear through her story and through the consequences of the decisions she made at FDA and throughout her work, that Dr. Kelsey carved out a life and a career that elevated the principles and values of science-based decision making to the highest level. There is no doubt she saved lives and saved many thousand individuals and their families from devastating damage

Dr. Kelsey’s contributions after the events of Thalidomide have received less fanfare and public notice, but may, in fact, be at least as important for the ongoing work of FDA and regulatory science.

Working with others, she helped to develop strategies and rules for medical testing that have resulted in the three distinct phases of clinical trials commonly utilized today. And drawing on her knowledge and experience, she also helped to really focus attention and strengthen rules and practices to address the critical issues of conflict of interest and human subject protection.

In so many ways, Dr. Kelsey has helped to define modern medical product testing and clinical trials. She has strengthened regulatory science in ways that have changed FDA forever, and her contributions have made a difference—and continue to make a difference—worldwide.

Today, we must build on her example. We must recognize the importance of bringing the best possible science to bear on all that we do: both importance of continually advancing regulatory science here at FDA and, working with others, the importance of continually building and extending the scientific framework for our regulatory work.

We must have the best regulatory science possible in practice at this agency, and we must recognize the need to commit wholeheartedly to our priority of strengthening the field for the future. For us to be the strong, effective public health agency we need to be—and we can be—we must approach those same principles of science with the same excellence and vigor that our honoree, Dr. Kelsey, did so many years ago.

After all, this award does much more than commemorate a 50th anniversary. It also celebrates the 49 years between then and now—years that were fundamentally and irrevocably shaped by the principles behind Dr. Kelsey’s decision…the principles of a woman whose example continues to inspire us today.

I am pleased to be able to also bring to this celebration the thanks and greetings of both our Secretary of Health and Human Services, Kathleen Sebelius, and our nation’s President, President Obama. Dr. Kelsey, you will receive the originals of these letters at your home. But I hope you won’t mind if I read them to you and the group assembled with us now.

[Letters from Secretary Sebelius and President Obama read by Dr. Hamburg.]

So Dr. Kelsey, as we honor you with this award, we also recommit ourselves to the scientific rigor and conviction with which you approached your job—and because of which, you transformed thousands of American futures. It is my privilege to present you with this award and to thank you for your extraordinary service to this agency and to this country.

And I speak for all of my colleagues when I say that it’s our honor—and our commitment—to continue your great work here at the FDA. Fifty years later, we still follow your lead—and promise that we will going forward.