The Food and Drug Administration, better known as the FDA, is a governmental agency that is under the purview of the Department of Health and Human Services. The FDA is tasked with protecting the health of the general public in the areas of a number of products, including the following:
- food safety
- veterinary products
- prescription and over the counter medicines
- ERED (electromagnetic radiation emitting devices
- dietary supplements and vitamins
- medical devices
- vaccines and biopharmeceuticals
- blood transfusions
The United States Food and Drug Administration came to be established on June 30, 1906. Prior to its incarnation as the FDA, the agency was a part of the USDA (particularly in the areas of chemistry). Between 1927 and 1930, the FDA was known as the Food, Drug and Insecticide Administration.
The headquarters of the FDA is located in Silver Spring, Maryland. The agency employs almost fifteen thousand individuals, and it operates on an annual budget of about $3.16 billion. The acting commissioner of the Food and Drug Administration is Janet Woodcock.
There are several “child” agencies of the U.S. Food and Drug Administration. They include the following:
- the Center for Veterinary Medicine
- the Center for Food Safety and Applied Nutrition
- the Center for Biologics Evaluation and Research
- the Office of Regulatory Affairs
- the Center for Devices and Rediological Health
- the Office of Criminal Investigations
- the Center for Drug Evaluation and Research
- the National Center for Toxicological Research
- the Center for Tobacco Products
The Food and Drug Administration is under the commission of the Commissioner of Food and Drugs, a position that is appointed by the president and confirmed by the Senate. The FDA’s mission is to enforce the Federal Food, Drug and Cosmetic Act. This piece of legislation was enacted by Congress in 1938, and it was intended to oversee the safety of products such as cosmetics, food and prescription medications as well as over-the-counter medications, and medical devices.
The FDA is also tasked with enforcing the Public Health Service Act, particularly Section 361 of the law. This means that the FDA carries out regulatory functions as related to a number of products including cellular devices and even lasers. The FDA is also tasked with the control of disease.
As of January 20, 2021, Janet Woodcock is the commissioner of the Food and Drug Administration, and she reports directly to the Secretary of Health and Human Services. While the FDA is headquartered in Maryland, the agency possesses 223 field offices as well as thirteen laboratories. These facilities are located across the United States as well as in Puerto Rico and the Virgin Islands.
The History of the FDA
Prior to the inception of the FDA in the early twentieth century, there were only a handful of federal regulations governing the food and pharmaceutical safety of the American Public. In fact, it was the latter part of the nineteenth century when the U.S.D.A (the United States Department of Agriculture) – specifically the Division of Chemistry of the USDA – began to investigate the safety of food and medical products available on the market for Americans. The chief Chemist at that time was Harvey Washington Wiley, and he led the push for investigating in unauthorized adulterations as well as misbranding of food and drug products.
The Food and Drug Administration came to be during a time of Progressive movements across the United States. Author Upton Sinclair had published his controversial book, The Jungle, which drew quite a bit of attention regarding the meatpacking industry. Wiley himself became an advocate of regulating food production as a result of Sinclair’s book as well as other influences. A diphtheria vaccine had been produced which ended up killing thirteen children; the incident prompted the Biologics Control Act of 1902.
Just four years later, President Teddy Roosevelt signed into law the Pure Food and Drug Act of 1906. It was nicknamed the “Wiley Act” after the chemist who had advocated so diligently for the new law. This new law prohibited the interstate transport of “adulterated food.” The Wiley Act also prohibited drugs which had also been adulterated; it also created the beginning of ingredient labels on food and drugs.
At that time, the Bureau of Chemistry under the leadership of Harvey Washington Wiley, ant the new law gave the responsibility of finding evidence of misbranding or adulteration in food and pharmaceuticals. Wiley himself would aggressively go after manufacturers who utilized chemical additives to the production of food. Ironically, not long after Wiley began this campaign, a series of judicial rulings began to cut down on Wiley’s powers within the Bureau of Chemistry. In addition, the rulings also set a group of standards for proof of fraudulent intent when it comes to manufacturing food and products.
By 1927, the Bureau of Chemistry’s powers had been reorganized into the Food, Drug and Insecticide Administration, and the name of the FDA that we know today was finally established by 1930.
However, journalists like Upton Sinclair – described as “muckrackers” due to their style of writing and bringing national attention to certain situations – did not stop in their campaign to make products safer for the American public. Under the 1906 law that Roosevelt had signed into law, there were still a number of products that were harmful, but still allowed to be manufactured under the law. These products included:
- radioactive drinks
- unproven cures for tuberculosis and diabetes
- a mascara, Lash lure, which was found to cause blindness
It took five years for the laws proposed after the muckraking journalists brought these products to light to meander through Congress for approval. However, when more than one hundred Americans died after using an over-the-counter medication that contained a toxic solvent, Elixir Sulfanilamide, the law (the Federal Food, Drug, and Cosmetic Act) was finally passed in both chambers of the Congress. Franklin Roosevelt signed int to law on June 24, 1938.
The new law required that all medications must have a pre-market review prior to their release on to the market. It also required that there could be no false claims as to the results of the product. It removed the idea of “fraudulent intent” that had been established during the time of Harvey Wiley.
Shortly after the 1938 Act was passed and signed into law, the FDA began to classify medications into two different groups – those that should only be dispensed to the public under the supervision of a doctor and those that could be purchased over-the-counter, such as aspirin.
The idea of prescription drugs was written into law with the Durham-Humphrey Amendment of 1951. This law gave the FDA the ability to recall harmful prescription drugs after they entered the market.
The drug approval process that the Food and Drug Administration utilizes today was put into place during the 1960s when the Kefauver-Harris Amendment was passed. This amendment added a requirement that all new drug applications must show a certain amount of efficacy when applying for the approval of a medication.
At the time, the new amendment had the effect of not only increasing the length of time that a drug was approved by the FDA and the time it would finally take for the medication to be available to the public. It also increased the difficulty by which medications were approved for public use.
The FDA has been associated with the development of both brand-name medications as well as the generic drug approval process. In 1984, the Drug Price Competition and Patent Team Restoration Act (also nicknamed the Hatch-Waxman Act) as well as the Abbreviated New Drug Application paved the way for the manufacture of both brand-name drugs as well as their generic counterparts.
The Food and Drug Administration requested that Endo Pharmaceuricals remove oxymorphone hydrochloride – an extended release medication for moderate to severe pain – from the American market. This was the first time the FDA had ever made such a request, and it was partially in answer to the opioid epidemic in the United States.
The Scope and Funding of the FDA
The FDA regulates over $2 trillion in products and goods in the United States. The FDA is responsible for monitoring the import of cosmetics and other such goods brought into the United States for resale.
Regulatory Programs of the FDA
The FDA is tasked with carrying out any necessary emergency approvals for products, such as it did for the COVID-19 vaccines. The FDA regulates almost every facet of the production process of prescription and OTC medications. The FDA publishes what are called “shaming lists” for companies that may use unlawful or unethical means to prevent competition.
The FDA is tasked with monitoring the claims of supplements – particularly the ingredients and the health benefits of said supplements.