The Food and Drug Administration (FDA) is a federal agency that has monitored the quality of food and drugs in the United States of America since 30th June 1906. There are many manufacturers and distributors around the country who want to make a large profit margin without considering the quality of the products. The reason for choosing to study this agency is because it is the one that gives the stamp of approval for distributing many products, and without it, companies would not reach their market. In 2019, the FDA implemented the new organization’s departments in line with the new technology and needs. This paper will expound on the FDA’s structural organization and some of its significant roles in maintaining quality food and drug products in the market.
Basic Structure of the Organization
FDA is an agency in the Health and Human Services Department. It consists of nine centers and thirteen new offices that play different roles in the company. The centers include; Biologics Evaluation and Research, Devices and Radiological Health, Drug Evaluation and Research, Food Safety and Applied Nutrition, Tobacco Products, Veterinary Medicine, Toxicology Research, Regulatory Affairs, and Operations. The Center for Biologics Evaluation and Research has regulated the production and distribution of safe biological products such as cosmetics, food, and drugs. The Center for Devices and Radiological Health promotes public health by ensuring proper medical products and practices. For instance, FDA provided new standards that regulate the amount of radiation emitted from imaging devices such as X-rays (Miller et al., 2021). The Center for Food Safety and Applied Nutrition ensures quality in locally produced, imported, and exported food items.
Besides protecting human health, FDA ensures safety and quality in animal products such as feeds through the Center for Veterinary Medicine. Additionally, the Center for Tobacco Products controls the growing of tobacco, manufacturing, advertising, and distribution of tobacco products. Tobacco is a legal drug in the United States of America, even though it is harmful to people’s health. The FDA sets performance requirements, reviews marketing authorization applications for creating and improving risk tobacco products, requires updated safety warnings, and establishes and enforces advertising and promotion limits under the Family Smoking Prevention and Tobacco Control Act. These responsibilities encompass the regulatory role of the FDA through its nine centers.
Fundamental Departmental Roles of the Organization
FDA is responsible for approving drugs that should be affordable and effective through the Center for Drug Evaluation and Research. Some newspapers articles question the work of the FDA, such as the “Furor rages over FDA approval of controversial Alzheimer’s drug” post by the Washington Post by Lauren McGinley. According to the article, the agency approved the drug as its trial treatments showed the reduction of amyloid, a compound in the brain that inhibits communication between brain cells which is a factor for Alzheimer’s (McGinley, 2021). Alzheimer’s treatment is a new venture in the medical field, and many people are skeptical about the new drug. The general public was infuriated by the drug’s treatment price, which would cost $65,000 a year. It is up to the FDA to approve effective drugs worth their price tag.
Market Regulation of Products
Nonetheless, many pharmaceutical companies have come up with vaccines, and after vaccines, they introduced boosters, which seemed like a market play for many consumers that which FDA should regulate. The regulatory offices are in charge of the market distribution of pharmaceutical products. Nonetheless, another newspaper article by The New York Times, “FDA Allows Second Coronavirus Boosters for Everyone 50 and Older,” reports on the FDA’s allowance of another booster (Lafraniere, 2022). To the public, a second booster shot is unnecessary. However, FDA announced its approval of the booster showing the need for 50-year-olds and older to take it four months after the first booster. The organization regulates the products in the market.
Nonetheless, the organization facilitates research to improve awareness about quality products. For instance, the organization established the Oncology Center of Excellence (OCE) on 17 January 2016. The body oversees many research and educational outreach projects and activities to advance the production and control of cancer-related medical products (de Claro et al., 2021). This facilitation of research is essential in creating cancer awareness, financing research projects, and educating people on the primary ways of preventing cancer. According to the review, cancer treatment products undergo a strict public submission process to the FDA, ensuring that there are efficient oncology products in the market (de Claro et al., 2021). The research facilitation helps in providing quality products.
The Food and Drug Administration plays a crucial role in maintaining the quality of food and drugs manufactured and distributed in the country. The organization has nine important centers that promote consumer safety and quality standards for food and drugs in the country. Its mission is to protect the consumers and ensure food safety. It also regulates the manufacturing of all food products and drugs ad heir distribution. It works on educating the public on standard products and those they should avoid for their safety. It also ensures the development of sustainable medical products through research.
de Claro, R. A., Gao, J. J., Kim, T., Kluetz, P. G., Theoret, M. R., Beaver, J. A., & Pazdur, R. (2021). US Food and Drug Administration: initial experience with the real-time oncology review program. Clinical Cancer Research, 27(1), 11-14.
Lafraniere, S. (2022). FDA allows Second Coronavirus Boosters for Everyone 50 and Older. The New York Times.
Miller, D. L., Kakar, S., Jiang, L., Spelic, D. C., & Burk, L. (2021). The US Food and Drug Administration’s role in improving radiation dose management for medical X-ray imaging devices. The British Journal of Radiology, 94(1126), 20210373.
McGinley, L. (2021). Furor rages over FDA approval of controversial Alzheimer’s drug. The Washington Post.