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Regulatory Agency Paper: FDA The History of Organization Healthcare is very important part of our life. People always want to be confident in government and regulations aimed to guaranty public safety. The Agency springs from 1906, when American government adopted the Pure Food and Drug Act. From the very beginning of its activity the Agency was known as the Division of Chemistry, then (after 1901) is was renamed into the Bureau of Chemistry. The Bureau of Chemistry was renamed into the Food, Drug, and Insecticide Administration in 1927 and only in July 1930 the name of organization was shortened till the name it is known by now: the U. S.
FDA (Food and Drug Administration). FDA is a regulatory, scientific and public health organization that oversees items accounting for 25 % of the consumer dollar (about a trillion dollars a year). FDA is a watchdog organization that encompasses the major part of foodstuff, all kinds of drugs (both animal and human), animal products, surgical and medical devices, cosmetics, therapeutic agents of biological origin, to mention a few. According to information from FDA Website, the administration grew from a single chemist in the U. S.
Department of Agriculture in 1862 to a staff of approximately 9, 100 employees and a budget of $ 1. 294 billion in 2001, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others (Swann: n. p. ). Agency functionaries are responsible for working out and implementation of new strategies and evaluation of regulations for new medical devices, drugs, color and food additives, etc. FDA controls import, manufacture, storage and sale of about $ 1 trillion worth of products annually at a cost to taxpayers of about $ 3 per person (Swann: n. p. ).
FDA Structure FDA is not an independent organization. It acts within the limits of the Department of Health and Human Services. The Agency consists of eight centers / offices : CBER (Center for Biologics Evaluation and Research) CDRH (Center for Devices and Radiological Health) CDER (Center for Drug Evaluation and Research) CFSAN (Center for Food Safety and Applied Nutrition CVM (Center for Veterinary Medicine) NCTR (National Center for Toxicological Research OC (Office of the Commissioner ORA (Office of Regulatory Affairs) Besides, there are two FDA-Affiliated Organizations: National Center for Food Safety and Technology Joint Institute for Food Safety and Applied Nutrition Mission The FDA Modernization Act (FDAMA) adopted in 1979 confirmed the important role FDA plays in public health protection. According to this Act, Fda's mission is as follows: To promote public health reviewing clinical researches and undertaking all measures in order to control the marketing of regulated products in time To protect public health and to ensure the U. S. citizens that products they utilize and consume are safe, wholesome, sanitary, and properly labeled (A Tour of FDA, Mission n.
p. ), the medical and surgical devices are safe and effective, and that public health is protected from electronic product radiation (n. p. ) To collaborate with representatives of other countries and health protection organizations in order to the burden of regulation, coordinate regulatory requirements, and achieve appropriate equivalent arrangements (n. p. ) According to regulations and recommendations of the Secretary of Health and Human Services, to consult with experts in medicine, science and health care and to be in touch with importers, retailers, manufacturers and consumers of products controlled and regulated by FDA, to fulfill tasks more effectively Carrying Out Day to Day Responsibilities Although it is extremely difficult to be on the look-out of new products, FDA makes all efforts to protect the consumers. Lets give several examples of FDA activity and dwell on them briefly.
For example, in 1962 the scientists discovered that a new sleeping pill, thalidomide causes birth defects in the Western Europe. FDA (and personally Dr. Frances Kelsey, FDA Medical officer) bent every effort to ban the drug from the American market. On Fda's advice Kefauver-Harris Drug Amendments were adopted in order to provide U. S. consumers with stronger drug regulation.
According to Kefauver-Harris Drug Amendments, drug manufacturers were required to prove the effectiveness of drugs before they will start marketing campaigns and promotion (Mugler, n. p. ). In 1966 the Food and Drug Administration concludes contract with the National Academy of Sciences/National Research Council. The aim of this contract is to evaluate the safety and effectiveness of four thousands human drugs adopted during 1938 - 1962. A little bit later the Agency approves Fair Packaging and Labeling Act. According to this Act, all consumer products regulated by FDA (medical and surgical devices, cosmetics, drugs, etc) must be labeled in a proper way.
In 1973 the Supreme Court supports drug effectiveness law of 1962 and sanctions FDA to control entire classes of products by regulations rather than to rely only on presumably more time-consuming litigation (Mugler, n. p. ) In 1976 Medical Device Amendments are approved (Monheit, Silverman & Fodera Website, n. p. ). Since then the manufacturers of FDA regulated products have to register with FDA and obey quality control regulations. FDA adopts a range of products that must be pre-market approved by FDA to ensure its safety. In 1984 in accordance with Drug Price Competition and Patent Term Restoration Act, the FDA get permission to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective (Mugler, n.
p. ) However, one of the most important efforts undertaken by the FDA was AIDS blood test (1985) approved to enhance protection of patients from AIDS infected donors. In 1987 the Prescription Drug Marketing Act prohibits the diversion of prescription drugs from legitimate commercial channels (Mugler, n. p. ). The Congress takes into account information presented by FDA and requires drug wholesalers to be licensed by the states (n. p. ). FDA strives for impossible and gets the permission to restrict drug re importation from other countries because it leads to distribution of mislabeled, adulterated, sub potent, or counterfeit drugs (n.
p. ). The 1990 s were well known for numerous scandals around silicone gel breast implants. FDA undertook an aggressive campaign because of reports of leaking breast implants and even produced a brochure to highlight the more common problems that occur in the breast or chest area (Breast Implants, n. p. ) The impact of FDA is great. The Agency regulates products (foodstuff, all kinds of human and animal lifesaving drugs, animal products, surgical and medical devices, cosmetics, therapeutic agents of biological origin, etc) accounting for 25 % of the dollar spent by U. S.
citizens. FDA network is huge and consists of eight departments with offices in over 40 states. The Agency's priorities in protecting and advancing Americas health involve all kinds of patient and consumer protection as well as efforts to empower consumers for better health by providing them with information they require to weigh the benefits and risks of FDA-regulated products and help them make smarter decisions about their health (FDA Progress and Priorities 2004, n. p. ) Bibliography: A Tour of FDA.
The Mission. Retrieved November 5, 2005. web Breast Implants - Potential Local Complications and Reoperation. Retrieved November 5, 2005.
web FDA Progress and Priorities 2004. Protecting and Advancing America's Health. Retrieved November 5, 2005. web Monheit, Silverman & Fodera Website.
Medical Devices. Retrieved November 5, 2005. web Mugler, M. (1996). A Brief History of the FDA. Retrieved November 5, 2005. web Swann, J.
P. FDA History Office. History of the FDA. (adapted from George Korean, ed. , A Historical Guide to the U. S. Government (New York: Oxford University Press, 1998) ). Retrieved November 5, 2005.
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