History and Overview of the FDA
Problems of contamination in food supplies have plagued consumers for as long as the concept of shared resources has existed. Toxicity or lack of effectiveness have been liabilities in the development of medicinal products throughout recorded history. From Hippocrates’ use of wine covered with fig leaves to treat wounds to the introduction of artificial skin, from chewing on willow bark to treat fever to genetically-targeted pharmaceuticals, the history of health care is brimming with stories of spectacular successes and catastrophic failures.
In the US and worldwide, food and drug safety issues have been addressed by a series of laws enacted throughout the last century. Enforcement of these laws is the primary role of the US Food and Drug Administration, commonly referred to as the FDA. The FDA is most commonly thought of in the context of approval of new drugs. Its mandate, however, actually extends far beyond pharmaceuticals. It is responsible for approval and oversight of a broad range of products including food, drugs, medical devices, radiation-emitting products, vaccines, blood and biologicals, veterinary products, cosmetics, and tobacco products. This presentation will briefly review the origin and evolution of this body into the important governmental agency that exists today.
The Department of Agriculture was established in 1862 by President Abraham Lincoln and immediately set out to address a myriad of issues related to food production and safety. As it became apparent that the problem of food adulteration was becoming more and more widespread, a special division of the Department of Agriculture- the Bureau of Chemistry- was charged with enforcing a ground-breaking statute known as the Federal Food and Drugs Act of 1906. The regulatory wing of the Bureau of Chemistry saw its responsibilities and authority evolve, and it ultimately became known as the Food and Drug Administration. In 1940, the FDA was removed from the Department of Agriculture and, after transitions through the Federal Security Agency and the Public Health Service of the Department of Health, Education and Welfare, today’s FDA is a division of the US Department of Health and Human Services.
Prior to the creation of the FDA and its antecedents, control of adulterated and misbranded foods and of drugs was haphazard, at best. State and local governments loosely and, often ineffectively, monitored food and drug production and claims of effectiveness for medicinal products. More often, the publication of information related to these topics and the resulting reactions of the public was left to individuals or citizen groups. Thus, the American Medical Association, the American Pharmaceutical Association, and journalists and authors were at the forefront of the investigation of these critical problems. A famous example was the publication of Upton Sinclair’s novel, The Jungle, which highlighted health violations and unsanitary practices in the American meatpacking industry, and which led to meaningful reforms.
Similarly, a tragic experience with a popular “wonder drug” exposed the lack of coordinated oversight in the pharmaceutical realm and spurred public outcry and legislative action. Sulfanilamide was a widely used and highly effective treatment for streptococcal infections. It had been used safely in tablet and capsule forms, with impressive curative effects, for almost three decades. In an effort to satisfy a regional demand for a liquid form of the medicine, a new formulation was developed in which the drug powder was dissolved in diethylene glycol, the unpleasant taste was masked with a flavoring agent, and this new “Sulfanilamide Elixir” was quickly dispatched, in September of 1937, to eagerly awaiting clinics throughout various sections of the country. Within weeks, there was reported a sudden rash of deaths in patients to whom this elixir was administered. In October and November of 1937, the drug was implicated in the deaths of more than 100 people in 15 states. Once the association to Sulfanilamide Elixir was identified, scores of FDA agents and others were sent out to recover the distributed medicine. Although diethylene glycol was commonly used as an antifreeze, its toxicity in humans was not yet widely known. Since safety testing was not required for drug formulations, the poisonous effects of this supposedly life-saving elixir came as a horrifying surprise. Public demands following this event precipitated the enactment of the 1938 Food, Drug, and Cosmetic Act that provided for a rigorous system of animal testing and controls in the development and approval of new drugs and formulations.
Numerous amendments to the original Food, Drug and Cosmetics Act, and additional related legislation in subsequent decades, have dramatically expanded the authority of the FDA to enforce regulations in a very broad arena. Today, FDA devises and enforces policies related to the development, testing, manufacturing, and marketing of a diverse range of food and health-related entities, including the following:
· - Testing insulin and antibiotics
· - Regulation of chemical pesticides
· - Regulation of food and color additives
· - Distinction between prescription and non-prescription medications
· - Regulation of drug efficacy
· - Ensuring good manufacturing practices
· - Control of prescription drug advertising
· - Regulation of therapeutic agents of biological origin
· - Oversight of nutrition labeling
In recent years, consumer demand and political pressures have led to FDA efforts to accelerate drug approval timelines, particularly for orphan drugs (for rare diseases) and for treatment of new illnesses, such as AIDS. FDA has responded to the needs of both patients and researchers by improving techniques for the development and testing of new drugs and drug formulations, as well as by extending patent protections to allow for time-consuming testing and approval processes. It has also modified the review process for generic versions of drugs in order to encourage and facilitate the development of lower-cost alternatives to brand-name products.
The over-arching responsibility of the FDA is to ensure, as far as possible, that the foods and drugs that we consume are safe and, in the case of pharmaceuticals and other medical products, will have a positive impact in the treatment of a medical condition. However, while lack of efficacy is a significant disqualifying factor for any drug being brought to the market, the basic guiding principle, first and foremost, is the same as that stated in the Hippocratic Oath that is sworn to by newly graduated physicians: “first, do no harm”.
 US Department of Heatlh and Human Services / US FDA website
 Taste of Raspberries, Taste of Death, The 1937 Elixir Sulfanilamide Incident, Carol Ballentine, FDA Consumer Magazine, June 1981