U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) is a federal agency established in 1906, originally formed as the Food, Drug, and Insecticide Administration. It is primarily responsible for ensuring the safety and efficacy of food products, drugs, medical devices, cosmetics, and various other products that impact public health. The agency plays a crucial role in the approval process for new drugs, closely monitoring research, packaging, and marketing practices. Over time, its jurisdiction has expanded significantly, particularly with the enactment of the Federal Food, Drug, and Cosmetic Act in 1938, which broadened its oversight to include cosmetics and the inspection of production facilities.
The FDA also regulates advanced biological products, vaccines, and tobacco products, reflecting its diverse responsibilities. While some critics question the concentration of power within the FDA and suggest decentralization to mitigate potential conflicts of interest, supporters argue that its comprehensive oversight is vital for safeguarding public health. The agency's significance was particularly highlighted during the COVID-19 pandemic, where its rapid response and emergency use authorizations were deemed essential for vaccine development and public recovery efforts. Overall, the FDA is viewed as a pivotal entity in the landscape of consumer protection in the United States.
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U.S. Food and Drug Administration (FDA)
- DATE: Established in 1906 as the Food, Drug, and Insecticide Administration within the US Department of Agriculture
- IDENTIFICATION: Federal agency that is responsible for the regulation of both drugs and foods in the United States.
SIGNIFICANCE: The US Food and Drug Administration, the first regulatory agency created in the United States to focus on consumer protection, has a more diverse and widespread jurisdiction than any other US agency in the regulation of food products and drugs. The agency oversees the safety of foods, drugs, medical devices, cosmetics, and other products and services that may affect the public health.
The US Food and Drug Administration (FDA) oversees a number of agencies that regulate foods and drugs. It is perhaps best known for its role in the process of the approval of new drugs seeking entry onto the market. The FDA closely monitors the research performed on drugs and the ways in which drugs are packaged and marketed once they are approved for sale. In addition, the FDA has a great deal of influence in regard to the preservatives and chemicals that are allowed in foods.
The FDA began as a watchdog agency focused on big businesses in the areas of commercial food and drug products. The pressure for the US government to establish an agency to oversee the safety of foods and drugs began to mount in the early twentieth century, when newspapers and books publicized the unsanitary conditions under which many foods were processed and kept. The FDA originated as a wing of the Department of Agriculture’s Bureau of Chemistry in 1906, when the Pure Food and Drug Act and the Meat Inspection Act were passed by the US Congress. The FDA was originally focused on investigating potential existing food additives and drugs that were harmful to consumers, but its jurisdiction soon began to grow. In 1938, with the passage of the Federal Food, Drug, and Cosmetic Act, the FDA extended its jurisdiction to cosmetics and the marketing of new drugs and also took on the inspection of factories.
The FDA continued to expand its regulatory jurisdiction with the development of new technologies. For instance, the agency oversees cell and tissue products, vaccines, gene therapy products, and other advanced biological products through the Center for Biologics Evaluation and Research, one of its many branch agencies. The Center for Devices and Radiological Health, another branch of the FDA, is responsible for approving medical instruments and overseeing their safety. The 2009 Family Smoking Prevention and Tobacco Control Act granted the FDA authority to regulate the manufacturing, distribution, and marketing of tobacco products.
Critics of the amount of power given to the FDA have argued for decentralization of the agency. They contend that because the FDA’s decisions have significant influence over the stock value of numerous companies, great potential exists for corruption and inappropriate influence on the agency by special interests. Proponents of the FDA argue that the agency's oversight is crucial for ensuring public health and safety. Indeed, the agency's role in the health of the country was evidenced by its response to the COVID-19 pandemic, which included emergency use authorizations (EUAs) for vaccines and treatments. Many saw the FDA's efforts during the crisis as instrumental to the rapid development of COVID-19 vaccines and the country's overall recovery from the pandemic.
Bibliography
"FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative." US Food and Drug Administration, 2 Apr. 2021, www.fda.gov/about-fda/reports/fda-covid-19-pandemic-recovery-and-preparedness-plan-prepp-initiative. Accessed 18 Dec. 2024.
Hawthorne, Fran. Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat. Wiley, 2005.
Hickmann, Meredith A., ed. The Food and Drug Administration. Nova Science, 2004.
Hilts, Philip. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation. Random House, 2003.