Ninety Years of Regulatory Evolution: From 1924 to 2014
In the early 1920s — a little over 90 years ago — the United States was being transformed by the rapid expansion of technology into everyday life. Think automobiles, radio, electricity, home appliances, and air travel. The key issues facing the President and the Congress were: job creation, tax reform, immigration, deficit spending and the role of government. Income inequality was a very hot topic! So, too, was balancing a war-weary population’s desire to withdraw from world affairs with a constant stream of events that seemed to require our involvement.
While much has changed, there are some very interesting parallels! Out of curiosity, I wondered how such a comparison might apply to the Food and Drug Administration.
In the 1920s, FDA had a small staff of scientists (mostly chemists) and a small staff of investigators. Its job was to enforce The Pure Food and Drug Act of 1906, which focused the agency solely on adulteration of food and drugs in interstate commerce. It’s job was wholly reactive.
Arrayed against the agency was a largely unregulated marketplace in food and drugs (some states had good laws, but those only extended to their borders). This was still the era of patent medicines with unknown ingredients and outlandish claims about therapeutic benefit. It was also an era in which food and cosmetics were often mixed with dubious compounds — leading to widespread illness from foods and disfigurement and blindness from cosmetics.
At that time, interstate commerce was narrowly defined, so the agency had to be able to document not only product adulteration, but also that goods had crossed state lines. There were no standards of identity to work from in judging adulteration. Outright fraud and willful disregard of public safety were common in the marketplace. Also, method of analysis was primitive — often FDA staffers and volunteers would ingest the food or drug to see if it caused harm.
With regard to FDA, the parallels to our own time turn out to be quite weak. While fraud still exists, it is a relatively minor part of the FDA’s work. Adulteration is still an important component of FDA’s mission, but it is mostly subsumed under the safety requirements for food and drugs that became law in 1938. The strongest similarity is the focus on enforcement — then the entire budget of the FDA and now about half of the budget authority appropriation. Even there, a major difference is the shift from domestic to global commerce.
What is striking is how much more sophisticated the food and drug world has become in 90 years and how much FDA has grown — in mission and size — to be able to stay ahead. Prevention of food safety problems is now a priority. Regulatory science is a target for investment. Drugs are now evaluated, pre-market, for safety and efficacy. Unknown in the earlier era were vaccines, drugs that actually work, biologics, packaged foods, mechanical refrigeration, and so on.
The FDA of today is built upon the agency of the past, but it has become much broader and vastly more sophisticated. The FDA is now vital — in a way it wasn’t 90 years ago — to both commerce and our nation’s health and well-being.
Note: This week’s analysis and commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA