NURS 6051 wk 11 : Federal Drug Administration

NURS 6051 wk 11 : Federal Drug Administration

NURS 6051 wk 11 : Federal Drug Administration


The Food and Drug Administration Abstract This paper aims to discuss the way the U. S Food and Administration department makes its rules and how the agency implements them. It also presents an analysis of the enforcement process in the United States and gives a way forward on the improvement in the enforcement of the law. Introduction Body Background of the Food and Drug Administration. How the FDA makes it rules Types of rules How the agency implements the rules Analysis of enforcement process f) Conclusion Background The Food and Drug Administration is a scientific agency of the U. S. NURS 6051 wk 11 : Federal Drug Administration

Department of Health and Human Services that oversees the regulation of food products, human and animal drugs, medical devices and radiation among other public health products. FDA was established in 1906 to establish a foundation that would foster comprehensive, and science-based protections that ensure the highest quality of products essential for health and survival in America. The department grew from a single chemist in the U. S.

Department of Agriculture and eventually became attached to the Department of Health and Human Services, as FDA in 1953. The agency boots of an administrative capacity of about 9, 100 employees within and outside of the Washington D. C. 1 On its work-list are chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, and lawyers, among others. How the FDA makes it rules FDA is a regulatory agency like many others in the U. S. As an agency it is empowered to create and enforce rules and regulations that carry the full force of a law.

Violation of its rules or regulations by individuals, businesses, and private or public organizations often results into sanctions, imprisonment, forced closure or fines undertaken by the regulatory bodies with support from government bodies. 2 Rules are defined as a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency according to web Regulatory bodies supervise operation of several sectors like banking, health, environment, education and energy in most economies. The following are some of the laws that the agency uses to ensure public safety: Sec. 1. Manufacture of Adulterated food or drugs, Sec. 2. Interstate commerce of adulterated goods, Sec. 3. NURS 6051 wk 11 : Federal Drug Administration

Rules and regulations, Sec. 4. Chemical Examinations (of foods and drugs), SEC. 9. Guaranty from manufacture and Sec. 10. Seizure of original packages. 3 The agency also has enforcement jurisdiction for provisions of these laws; Fair Packaging and Labeling Act (FPLA), Public Health Service Act (PHSA) and Public Health Security and Bio-terrorism Preparedness and Response Act. 4 Other examples of regulatory agencies that enforce public health safety measures include; the Administrators In Medicine (AIM), Federation of State Medical Boards (FSMB), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Medicaid and Medicare and United States Department of Health and Human Services. 5 The rules that implemented by these agencies are commonly discussed and passed by the Congress. In other countries, it is the obligation of parliament to pass the laws by which the regulatory agencies should govern their areas of concern. 6 In addition, rules are not created randomly considering the impact of their outcome on the public. The rules are formed with the publics help.

All citizens are given chance to submit their thoughts about the rules proposed by the FDA, before the Congress endorses them. The department offers telephone numbers and e-mail addresses to consumers to facilitate communication between it and them according to the departments website. 7 In America, the FDA is the primary regulatory agency impacting the food industry with regard to food safety, food adulteration, and food labeling or misbrand ing. However, majority of the food-related regulatory activity is within the Center for Food Safety and Applied Nutrition according to the FDA website web The agency inspects and regulates domestic and imported food (including shell eggs, bottled water, and wine beverages with less than 7 % alcohol) sold in interstate commerce, except meat, poultry, and processed egg products (which fall under the Usda’s Food Safety and Inspection Service) according to the FDA website. Its responsibility covers the Federal Food Drug & Cosmetic Act (FDCA), Nutritional Labeling & Education Act (NLEA); and Dietary Supplement Health & Education Act (DSHEA) federal acts in addition to the one mentioned above. Under authority of the Federal Food, Drug and Cosmetic Act (FDCA), the FDA has primary jurisdiction for the prevention of adulteration and misbrand ing of foods, drugs, and cosmetics sold in interstate commerce. Food is considered adulterated if it contains a residue of a physical, chemical or microbial agent at an unsafe level. NURS 6051 wk 11 : Federal Drug Administration

In addition to the presence of an unsafe level of a substance, a food is also considered adulterated under the FDCA if a food product is deemed to be prepared, packed, or held under unsanitary conditions or has not been manufactured under current Good Manufacturing Practices or economically damaged. 8 Packaged food is considered misbrand ed when the label or labeling is considered false or misleading, or if it is not labeled in accordance with FDA labeling regulations (7). Also when the packaged food products are not in conformity with have appropriate nutrition information in accordance with the Nutritional Labeling and Education Act (NLEA). It is also mandatory that dietary supplements must be appropriately labeled in accordance with the Dietary Supplement Health and Education Act (DSHEA). 9 Enforcing the rules The FDA administers its rules through Americas 57 States. Contracts to enforce the rules are awarded through tenders to the various states. Under these contracts, the states conduct more than 188, 000 compliance checks according to web For example by close of FY 1998, FDA had signed contracts with 43 states and territories totaling $ 16, 382, 912.

Under these contracts, the states conducted more than 188, 000 compliance checks by September 30, 1999 according to the Department of Health and Human Services. 10 In bid to achieve publicity among the consumers and other stakeholders in the states, the agency designs a comprehensive outreach program, which informs and ensures compliance to the rules it sets. The campaign includes advertising, direct mail, press events, exhibitions, speeches and on-line information dissemination according to web FDA also publishes rules that establish regulation of foods, drugs, biologics, cosmetics, radiation-emitting electronic products, and medical devices. According to Elder, (2006) FDA conducts inspections and surveillance of establishments throughout the nation, at ports of entry, and in foreign countries, to enhance safety and integrity of the products in America. In addition, the agency gathers and analyses samples of products to determine their safety, effectiveness, quality, purity, and truthfulness of labeling. In addition, the agency chemists and inspectors, the agency carries out its work with the help of laboratories and inspection offices spread around the nation. NURS 6051 wk 11 : Federal Drug Administration

Their work is facilitated by thorough research and study, and resourcefulness that have helped them meet technology advancements in product and manufacturing technology. Agency scientists also evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $ 1 trillion worth of products annually at a cost to taxpayers of about $ 3 per person. Investigators and inspectors visit more than 16, 000 facilities a year, and arrange with state governments to help increase the number of facilities checked. 11 As part of the agency’s broader initiative to ensure the safety of the public, FDA prohibits through warning letters, manufactures and distributors of unapproved drugs that could endanger the lives of Americans. For example on March 1 2007, the FDA told 20 companies to stop marketing unapproved drug products containing ergot amine tartrate.

This followed the discovery of unapproved drugs that pose a real risk to the American public and the need by the agency to ensure a safe and effective drug supply for the American public. FDA also urged consumers who were using ergot amine products to ask questions regarding their health care provider. For example, the FDA issued a warning letter to Aventis Pharmaceuticals of Bridgewater, N. J. , last November after milder notices about ads for its cancer drug Taxotere failed to produce what the agency considered an adequate response. 11 When an individual (s) or companies fail to meet the requirements of the agency, it takes a range of disciplinary actions against them. The penalties that took shape in 1956 are administered to the culprits. These include seizure, injunction, disqualification of clinical investigators, civil money penalty cases, examples of the types of Warning Letters issued, and recalls and prosecution. NURS 6051 wk 11 : Federal Drug Administration


For less serious, less threatening breaches, informal means are used to achieve compliance. More formal written warnings are issued in other situations where prompt corrections are expected to achieve full compliance with the law. Violators who do not heed these warnings, however, or whose actions pose a more serious public health risk may be subject to more formal and severe measures. 12 In a nutshell, FDA extensively carries its work and has succeeded almost all its efforts over the years however; it does not comprehensively meets its administrative roles because of certain limitations. This is because it lacks adequate manpower and often leaves its work to a few people who are often overwhelmed by the bulk of work. In his article, FDA struggles to police Print ads for Prescription Drugs. Pugh (2006), says because the FDA is understaffed, drug ad campaigns are sometimes over before the agency’s watchdogs spot a faulty ad.

When the FDA does object, drug companies sometimes respond slowly or incompletely, with the same result: Consumers are left with misleading impressions of how safe and effective advertised drugs are. On another occasion, only 18 FDA reviewers were assigned to scrutinize the roughly 37, 000 drug ads and promotional materials that drug companies submitted last year. The manpower was half the required manpower and thus could not produce adequate reviews that were required by the department. Pugh also reveals that drug companies have little motivation to respond quickly to FDA complaints because the agency isn’t using the legal authority it has to seize drugs or take violators to court. Instead, the Bush administration says proposed sanctions must pass a new review by the FDA’s general counsel.

Congressional investigators say that slowed efforts to crack down on dubious ads. In my opinion, I think decisions made by the FDA should be independent of any of the Bush administration. Simply because the FDA is conversant with the environment within which it works and is free from economic pressures. The department needs to hire more scientists to administer its regulation and enforce the rules it makes. Further strengthening should be done through development in the departments technology know how since theres an evolution of products and birth of new ones almost every other new day. The department should also hire sound media monitoring agencies to closely monitor advertisers of products that do not conform to its laws.

By so doing, it will improve its capacity to limit the unapproved food and drug products from getting sold on the market. The end result will be better and less endangered lives of most Americans. ? Bibliography 1. David, K. Elder (1956). The Enforcement story / The Impact of the Food and Drug Administration on Our Society, Published by MD Publications, New York. 2. NURS 6051 wk 11 : Federal Drug Administration