- Speech by
Norman E. "Ned" Sharpless, MD
Acting Commissioner of Food and Drugs - Food and Drug Administration
White Oak, MD
(Remarks as prepared for delivery)
Thank you Shelisha. Good morning everyone, and thank you for joining us for this momentous – one might say historic -- occasion.
That’s not only because today is the official opening of this amazing exhibit documenting FDA’s history, but because it falls precisely on the 81st anniversary of the enactment of the 1938 Food, Drugs and Cosmetic Act, the law we operate under today.
I’m a big fan of history. Not just in the academic sense, because it’s interesting to learn how things came about, or who was responsible for inventing something, or why something is named for someone.
For me, history has always been especially important and relevant because of what you can learn from it by applying it to current situations and needs.
For example, as an oncologist, I’ve seen how charlatans prey on the vulnerability of cancer patients (both human and animal) by trying to sell them fraudulent cures for their cancer.
FDA has a long history of making sure that when a medicine is touted as a medicine it does what it says it’s going to do. And studying that history not only gives us an understanding of FDA’s role, but how and why we go about protecting the health of the public.
So you won’t find it surprising that I find a great deal of truth in the famous quotation that “those who don’t remember and learn from history are condemned to repeat it.”
I might even suggest that this aphorism is the ultimate FDA consumer warning.
So we need to study and understand our history to be able to make good decisions today. And FDA’s history is a long and distinguished one, marked by the noteworthy achievements of committed and often courageous people. 0
One of those people – Harvey Wiley, was the seventh person to hold the position of USDA Chief Chemist. It was largely thanks to him that the 1906 Pure Food and Drug Act was passed, setting FDA on the road to consumer and patient protection.
But Harvey Wiley is just one of many individuals who played key roles in FDA’s long history of protecting and promoting the public health. This new exhibit captures a number of these revealing and often inspiring stories.
For instance, the exhibit documents the work of Alma Hayden, a Branch Chief in the Division of Pharmaceutical Chemistry in the Bureau of Medicine, who led a team of FDA scientists who helped uncover the chemical identification of a worthless but popular cancer treatment called Krebiozen in the 1960s as creatine, an amino acid known since the early 19th century.
It tells the story of William T. Ford, an inspector in the Cincinnati District Office, who was known as the “Dean of Inspectors” for his leading role in many major investigations, including the efforts to recover tainted Elixir Sulfanilamide from the market in 1937.
And it recalls the tale of Ruth deForest Lamb, the first person to hold the title of Chief Education Officer, who helped craft a successful campaign to inform the public, the press, and Congress about the dangers of the marketplace and the need for a new and improved law to replace the 1906 Food and Drugs Act.
These and many other tales are why the exhibit we proudly open today is called “Our Story.”
While statutes and regulations may create our legal responsibilities and authorities, the driving force behind their application and enforcement is the many FDA employees dedicated to public service.
It’s about people working together without special recognition, whether to develop and approve approving a lifesaving medical product, craft a policy that bridges the space between a law and its execution, develop a campaign to communicate important health information to the public, or interdict and remove a deadly item from the market.
Of course, “Our Story” also is designed to remind us that we don’t work in a vacuum. It’s not just FDA staff that shapes our work. The perspectives of patients and advocates and outside experts have long been a vital part of our ability to effectively fulfill our public health mission.
So this exhibit is also about those lured into believing that worthless products could help them, especially when safe and effective treatments existed.
It’s about patients and advocates who champion changes in the law that will help develop new therapies that help millions of people.
For example, “Our Story” includes the heartbreaking letter sent by the mother of Joan Marlar, the six-year-old killed by Elixir Sulfanilamide, to President Franklin Roosevelt to plead for a law to prevent such deaths from happening again.
The exhibit also allows visitors to come face-to-face with products that changed the course of medical history, such as the test kit for HIV, the Dalkon Shield, and thalidomide.
And it includes examples of the work done by our diligent inspectors in the field.
Importantly, this exhibit also is designed to showcase some of the ways our agency evolves, adapts and improves our work to reflect changes in market and society, in science and technology, to public health threats, to legal requirements, and to help inform and educate the public.
For example, the 1938 Food, Drug and Cosmetic Act (which replaced and strengthened the 1906 law) specifically authorized FDA to publish material relating to matters of imminent danger to health or gross deception of the consumer” involving the commodities we regulate.
That law allowed FDA to distribute warning posters about harmful cancer treatments and dangerous medical devices in the 1950s, 60’s and 70s. And to provide public service announcements on consumer product safety, food labeling initiatives, informed over-the-counter drug use, and prevention of youth tobacco use, to name just some of what you’ll see included in this exhibit.
We’re the oldest federal regulatory agency, and our work touches, safeguards and improves the lives of millions every day. FDA employees are proud to work here, and the history you’ll get to experience in “Our Story” explains some of why this is the case.
I want to congratulate everyone involved with the development of this important and exciting project, and I hope you all take the time to study this exhibit … and our history more closely.