Hcs/430 Regulatory Agency
Regulatory Agency
Michelle Grubb
HCS430
June 3, 2013
C. Darnell Stroble, Esq.
Regulatory Agency The role and responsibility of the U.S. Food and Drug Administration (FDA), most importantly, is to uphold the laws dictated by the government concerning products that include drugs, medical products, food, and non-health related products and to protect and promote public health across the country. This essay focuses on several aspects of the FDA, from the role of the agency and its effect on health care in the United States, to the authority this agency carries in relation to health care. There will also be an explanation of how the FDA carries out these responsibilities on a day-to-day basis. The FDA has held a strong presence in the realm of public health since 1848 when it began as a consumer protection agency (FDA, 2013). The FDA, formed after the 1906 Pure Food and Drug Act was put in place and inspired by the scientific work of Harvey Washington Wiley, who was the Chief Chemist at the U.S. Department of Agriculture. Wiley worked to eliminate the dangerous practices of marketing unregulated drugs and food products to consumers (FDA, 2013). Since that time, the FDA has become a powerful force, monitoring and working to protect public health in the United States.
FDA Role The FDA is an agency that works within the Department of Health and Human Services. The Office of the Commissioner takes the lead role with four other branches that manage other functions (FDA, 2013). The Office of the Commissioner takes “leadership of the agency’s scientific activities, communication, legislative liaison, policy and planning, women’s and minority health initiatives, agency operations, and toxicological research” (FDA, 2013). The four groups that work under the Office of the Commissioner are the Office of Foods, the Office of Global Regulatory Operations and Policy, the Office of Medical Products and Tobacco, and the Office of Operations. The function of these five
Michelle Grubb
HCS430
June 3, 2013
C. Darnell Stroble, Esq.
Regulatory Agency The role and responsibility of the U.S. Food and Drug Administration (FDA), most importantly, is to uphold the laws dictated by the government concerning products that include drugs, medical products, food, and non-health related products and to protect and promote public health across the country. This essay focuses on several aspects of the FDA, from the role of the agency and its effect on health care in the United States, to the authority this agency carries in relation to health care. There will also be an explanation of how the FDA carries out these responsibilities on a day-to-day basis. The FDA has held a strong presence in the realm of public health since 1848 when it began as a consumer protection agency (FDA, 2013). The FDA, formed after the 1906 Pure Food and Drug Act was put in place and inspired by the scientific work of Harvey Washington Wiley, who was the Chief Chemist at the U.S. Department of Agriculture. Wiley worked to eliminate the dangerous practices of marketing unregulated drugs and food products to consumers (FDA, 2013). Since that time, the FDA has become a powerful force, monitoring and working to protect public health in the United States.
FDA Role The FDA is an agency that works within the Department of Health and Human Services. The Office of the Commissioner takes the lead role with four other branches that manage other functions (FDA, 2013). The Office of the Commissioner takes “leadership of the agency’s scientific activities, communication, legislative liaison, policy and planning, women’s and minority health initiatives, agency operations, and toxicological research” (FDA, 2013). The four groups that work under the Office of the Commissioner are the Office of Foods, the Office of Global Regulatory Operations and Policy, the Office of Medical Products and Tobacco, and the Office of Operations. The function of these five
References: Hitt, E. (2012). Some FDA Warnings Have Minimal Effect. Medscape Medical News. Retrieved June 2, 2013 from www.medscape.com. FDA. (2013). U.S. Food and Drug Administration. Protecting and Promoting Your Health. Retrieved June 2, 2013 from www.fda.org. Writing, A. (2013). FDA Certification Requirements. EHow. Retrieved June 2, 2013 from www.ehow.com