Hcs/430 Regulatory Agency

Topics: Food and Drug Administration, Health care, Pharmacology Pages: 5 (1496 words) Published: June 17, 2013
Regulatory Agency
Michelle Grubb
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 entities of the FDA is to protect and promote public health in the U.S. and to uphold the laws dictated by the government regarding public health. This is accomplished through close monitoring and testing of regulated products used by U.S. consumers. These products consist of drugs, food, cosmetics, radiation-emitting products, vaccines and other biologics, veterinary drugs and products, and tobacco products (FDA, 2013). The FDA is also constantly looking for ways to advance public health by assisting other organizations to make medications safe and more effective (FDA, 2013). Not only does the FDA monitor the food supply coming into the U.S. to ensure its safety but also plays a role in counterterrorism efforts by developing products and medications to respond to a public health threat (FDA, 2013). Issuing and enforcing warning labels for drugs and other products is another function in the role of the FDA. The labels serve to educate the public and medical professionals on the use and hazards of using a specific medication or product. However, these labels do not always have the desired effect. Impact on Health Care

The efforts of the FDA throughout its history, has created a much safer consumer environment as it relates to food products, cosmetics, and other non-medical items. Foods are carefully scrutinized before they are allowed on the market to ensure these products are safe for the public to consume. Strict guidelines are in place for all types of products that are available to consumers. However, there is some controversy concerning warning labels on prescription drugs. There have been recent reports that communications by the FDA regarding drug risks are not immediately effective (Hitt, 2012). It is the duty of the FDA to monitor and enforce warnings for prescription drugs involving the safety risks to public health. According to Emma Hitt, some of the warnings that recommended increased monitoring of a patient while taking a prescription drug or...

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
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