The United States Food and Drug Administration (FDA) has gone through numerous changes since its inception in 1906 but its core mission remains the same; protecting the health of the public by ensuring safe, efficacious, and secure drugs, biologic products, and medical devices reach consumers and making sure the country’s food supply, cosmetics, and products that emit radiation are safe. In addition to its responsibilities in regulating food, drugs, and cosmetics, the FDA also regulates tobacco products including its manufacturing, marketing, and distribution.

The evolution of the FDA has mostly been the result of an unfortunate event leading to the harm or death of people. It was a way for the government to ensure that certain precautions were taken so that such terrible events did not repeat itself. The Pure Food and Drugs Act of 1906 was a piece of legislature signed by President Theodore Roosevelt that defined some of the modern regulatory function of the FDA, although the FDA didn’t adopt its current name until 1930. Prior to 1930, the FDA was called Food, Drug, and Insecticide Administration. The Pure Food and Drugs Act of 1906 prohibited interstate commerce of misbranded and/or adulterated foods, drinks, or drugs. This act was passed after it was discovered that many food and drug factories were using poisonous preservatives and food dyes and misleading statements about drug ingredients on drug labels. At this point in history, drug companies did not have to prove the efficacy or safety of its drug product in order to sell it to consumers. The Sherley Amendment of 1912 prohibited drug manufacturers from making false therapeutic claims on their labeling. In 1937, a poisonous ingredient called diethylene glycol found in a drug called Elixir of Sulfanilamide resulted in the death of 107 people, many of whom where children. This tragedy yielded the passage of The Federal Food, Drug, and Cosmetic (FTC) Act of 1938 which gave the agency new charges some of which included more control over cosmetic and therapeutic devices, requiring new drugs to show they are safe, establishing a level of safe tolerance for unavoidable poisonous substances, and factory inspections. The FDA’s role in ensuring the safety and efficacy of certain drug products began in the 1940s.

The Insulin Amendment of 1941 required the FDA to test insulin products for purity and potency before it could be used by the consumer. In 1945, the Penicillin Amendment passed which required the FDA to test and certify that all penicillin products were safe and effective. There were other amendments passed later on that extended this requirement to all antibiotics. It wasn’t until the Thalidomide event and the passage of the Kefauver-Harris Drug Amendment of 1962 that all drugs had to prove its efficacy and safety to the FDA prior to marketing the drug product. Thalidomide was a drug used as a sleep aid in Europe in the late 1950s to early 1960s. Its popularity grew when it was discovered that thalidomide was also effective in treating morning sickness in pregnant women, although this was not an approved indication (off-label) of the drug. The off-label use of thalidomide meant that it was never tested in pregnant women for the treatment of morning sickness, therefore, the long-term effects were unknown. An association between thalidomide use during pregnancy and offspring being born with a condition called phocomelia was quickly discovered. Phocomelia is a developmental disorder where the baby is born with absent or shortened limbs. Around 160 babies were affected by phocomelia in Europe which resulted in the removal of thalidomide from market.

A baby born without arms in 1963 after her mother took thalidomide for morning sickness during her pregnancy.

One of the most significant amendment that continues to impact our current laws and regulations in regards to medication use is the 1951Durham-Humphrey Amendment which delineated the types of drugs that could not be safely used by the consumer unless under medical supervision. This restricted the sale of these drugs to those with a prescription from a licensed healthcare provider. This continues to be enforced in our current practice of medicine as we categorize drugs as prescription or over-the-counter (OTC). Over-the-counter medications are certified by the FDA for safe use by the consumer without the need of direct medical supervision. Prescription medications are drugs that have been proven safe and effective in clinical trials but requires medical supervision because drug use by the consumer needs to be monitored to ensure continued positive outcomes. When prescription drugs are used without medical supervision, it can lead to patient harm.

The evolution of the FDA since its establishment has been driven by concern for public safety. The acts and amendments mentioned in this article are merely a few compared to the overall evolutionary timeline of the FDA.

For a more detailed version of the FDA’s historical timeline, you can visit:

www.fda.gov

Elif Özdener, PharmD