By Ned Sharpless, M.D., Acting Commissioner
History was made today at the U.S. Food and Drug Administration (FDA). That may not sound like news, since the Agency takes important actions every day that impact the health and safety of the American public. But today, it is a big deal because the Agency unveiled its first permanent exhibit documenting the FDA’s history at the White Oak headquarters in Silver Spring, MD.
In such a fast-paced, forward looking, science-based Agency as the FDA, we don’t often take the time or have the opportunity to look back at our history. But that kind of reflection is important and beneficial. It has been said that you need to study the past if you want to define the future. The new exhibit, entitled “Our Story,” includes many of the noteworthy achievements in the FDA’s long history. Just how long that history is depends, like most records, on the date you measure it from. One key date in the FDA’s past is 1906, when the consumer protection authority of the FDA was created with passage of the landmark 1906 Pure Food and Drugs Act. Though earlier laws relating to foods and drugs existed, this was the first focused on consumer protection. It provided what was then called the Bureau of Chemistry the authority to protect the nation’s food and drug supply, and mandated improvements in both the make-up and labeling of foods and drugs traveling in interstate commerce. That timeline would put the Agency’s history at 113 years.
By another measure, we can trace the history of this Agency all the way back to 1862. That’s when the head of the U.S. Agriculture Department under President Abraham Lincoln appointed the first chemist to research grape varieties for their sugar content and other qualities to help develop the early wine industry in the U.S.
By any measurement, one of the FDA’s greatest strengths has been the way the Agency marshals scientific expertise to respond to changes in science and technology, health, and industry, and to address public health crises that may stem from new and unprecedented developments. It also plays a key role in informing and educating the public about these developments in a timely, targeted, and responsible way.
Learn more about the FDA’s new permanent exhibit on the White Oak campus by taking this video tour with the FDA’s historians, John Swann and Vanessa Burrows.
Understanding Our History Helps Inform Our Future
A better, fuller understanding of FDA’s past, and the people who shaped the Agency and made it what it is, can inform and support the work today to address 21st Century challenges and protect the public.
Learning about the passage of the 1938 Food, Drug, and Cosmetic (FD&C) Act, for instance, which remedied many of the shortcomings of the 1906 Act, leads to understanding of how the public and their elected representatives can bring about change in the law to protect consumers. That important statute was enacted in the wake of a therapeutic disaster in which an untested drug killed more than 100 patients.
The impact of that legislative change was even broader. It brought cosmetics and medical devices under federal regulation, implemented standards of identity for foods, drug and medical device labeling, and required companies to provide evidence to FDA of a new drug’s safety before marketing. And, since its initial enactment, the FD&C Act has been amended many more times over the years, sometimes adding to FDA’s regulatory authority in response to new technologies, such as radiation-emitting devices.
The Heroes of Yesterday Reinforce Our Responsibilities Today
At the core of the FDA’s new history exhibit are the important contributions made by FDA staff, as well as FDA stakeholders and outside experts, advocates, patients and consumers. Each play an essential role in the Agency’s efforts to understand which products work, which cause harm, and what our society must do to better address the health needs of our population. Their stories demonstrate the many ways the FDA continues to build on the successes and challenges of the past to ensure the continued fulfillment of our mission to protect and promote the health of the public today and in the future.
Having greater awareness of the work of Alma Hayden, a branch chief in the division of Pharmaceutical Chemistry in the Bureau of Medicine, for example, reinforces our understanding of why we need to be vigilant in our review of products that claim to treat or cure disease. During the 1960s, Hayden helped uncover the chemical identification of a worthless but popular cancer treatment called Krebiozen.
Similarly, the story of Dr. Frances Oldham Kelsey, the scrupulous medical officer who refused to give FDA approval to the drug thalidomide in the early 1960s, reminds us how important it is to make sure that claims about a treatment are backed up by the best evidence possible, including legally mandated testing.
Equally valuable is the drama of the Poison Squad, a group of young men who worked for Harvey Wiley, the “father of the FDA,” during the first years of the 20th century. They were part of a groundbreaking five-year study to assess the safety of chemicals to preserve foods or mask unappealing qualities, collecting evidence of dangerous food adulterants, and testing the products on themselves. Their findings and the wide interest in these experiments helped spur public support for the 1906 Pure Food and Drugs law. Today, their courageous actions reminds us how important it is to ensure a rigorous body of scientific evidence with which we can evaluate the safety of foods and link adverse events with food additives.
The exhibit also offers educational examples of some of the different and interesting ways we’ve worked to make sure the public is informed on areas such as nutrition, including with the help of famous athletes, movie and television entertainers, and even Curious George. Public education is a key aspect of our responsibilities for everything we do to protect the public health.
The FDA’s History is the Health of Patients and Consumers
Of course, the primary focus of the FDA’s work is the impact it has on protecting patients and consumers, who are not only the focus and beneficiaries of the laws the FDA enforces, but also central to determining what laws are needed and what products require greater scrutiny and oversight.
Their engagement can affect our innovations in new science and cures, and help to prevent the marketing of products that may harm patients or consumers. At times, it involves the risk and sacrifice of patients themselves, as well as those who treat them.
It’s why Miles Coulson, the 5-month-old who received a medical device known as the Berlin Heart in 2004 and remained on it for nearly two months until undergoing a successful heart transplant, is so important to the history of the FDA and medicine.
It’s why the new exhibit documents the activism of protesters from the AIDS Coalition to Unleash Power (ACT UP), who gathered outside FDA headquarters in 1988 to call for greater access to experimental treatments and faster approval of AIDS drugs. Their activism helped spur the Agency to invite greater patient engagement in the policy-making process.
Understanding the importance of that protest movement, as well as the 1985 approval of an HIV test kit to help protect the blood supply, illustrates the impact of this unprecedented health crisis. But even more important, it underscores why the FDA listens to the patients, and how the Agency musters the best possible regulatory science to respond to rapid changes in science and technology in the interests of the public health.
It’s a different world and a different Agency than the one that began with a single chemist working in a small laboratory in the basement of the U. S. Patent Building. The FDA has grown into a sophisticated federal consumer protection Agency with a broad and constantly evolving public health mission and workforce across the nation and the globe. Today, the FDA regulates products accounting for about 20 cents of every dollar spent by U. S. consumers. Our work protects consumers and patients, helps advance scientific innovation, and educates the public to make informed choices about their health.
The FDA continues to understand and learn from its history, in order to inform its work, and achieve the kinds of conscientious science-based decisions that enables the Agency to fulfill its mission. It is our hope that partners, visitors, students, the public and FDA employees experience the new exhibit and gain a better understanding of how our Agency has evolved over the years and how its history continues to pave the way for the future.
Those unable to visit the exhibit in person, can still explore this fascinating Agency history by browsing a Flickr album featuring items in the exhibit, viewing this video tour of the exhibit, or watching some of these videos about aspects of FDA’s history that are part of the exhibit.