...One of the oldest U.S. consumer protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards. As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States. It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation's blood supply. To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action. Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways. The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the scientific...
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...2006, p. 319) The clinical trials are designed to obtain regulatory approval to market new pharmaceutical or biotechnology products. (Kaluzny & McLaughlin, 2006, p. 319) The services they perform for such clients as pharmaceutical companies include: “consulting and advice related to the design of drug development programs to labor-intensive services that are part of the drug development process; these include clinical monitoring of investigational sites, data management and statistical analysis, and presentations of regulatory submissions for review by regulatory agencies such as the U.S. Food and Drug Administration”. (Kaluzny & McLaughlin, 2006, p. 319) The FDA in the United States clearly mandate practices to protect the public’s health by implementing laws, regulations, and guidelines that provide oversight of the drug development process. (Kaluzny & McLaughlin, 2006, p. 322) The FDA requires the CRO to complete an IND or investigational New Drug application. “The pharmaceutical industry sometimes seeks advice from the FDA prior to submission of an IND”. (The FDA’s Drug Review Process, 2011) Throughout the whole process the FDA participates or more like regulates these clinical trials. The CROs as well as the...
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...to understand and keep up with all of the laws and regulations would by a full time job. The information available is very vast and the types of laws and regulations can vary depending on what type of health care facility or physicians practice that are being addressed. The government whether it is local federal or state are where these laws and regulation are made and implemented. There are also private sectors and organizations who help to develop regulations. To try and understand what the laws or regulations are about or who or what they might be meant for, there needs to be an understanding of what the agencies are that regulate them. When we look at the federal jurisdiction there are some that once said many people are familiar with such as Center for Medicare and Medicaid, CDC (Centers for Disease Control and Prevention, and the FDA(Food and Drug Administration). The state level agencies would consist of the following, welfare department, insurance, and the health department. The private sector brings organizations in which play important roles when it comes to health care laws and regulations. The following are part of the private sector organizations NCQA (National Committee of Quality Assurance) and JCHAO (Joint Commission on Accreditations of the Health care Organization). With so many laws and regulations, only two governmental agencies will be viewed and focused on to try and understand and see how they are used, and work or not work in today’s health care. ...
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...January 1, 2012 8:52 PM Chapter 44 Lecture Note # 1 by Spring Walton Note edited by Spring Walton on 01/03/2012 08:07PM Chapter 44 Consumer Protection I. Introduction Consumer law issues include those of contracts (including UCC sales), torts, crimes, and product liability, often acting as a backup to the failures and shortcomings of those other areas of the law. All of them provide some measure of consumer protection, yet none stand alone as being complete. They are interdependent and, as such, students must be aware of the big picture of consumer protection. This chapter covers the fourth major set of venues within a quadripartite of remedies available to a wronged or injured consumer. First, there is criminal law. Victims of consumer fraud and similar offenses have always been able to seek state-supported sanctions against wrongdoers. This venue may provide some ephemeral satisfaction for the victim and may even, at least temporarily, protect society from further harm. But criminal law does not truly make the victim whole. As a matter of fact, most of the miscreants convicted of consumer fraud are also judgment proof, i.e., they have no assets from which civil judgments can be satisfied. The second area of consumer protection is found in tort law and the permutations of intentional tort, negligence tort, and strict liability. These remedies can and do provide meaningful substance to civil correction of wrongdoing...
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...present amongst many educational institutions all over the world, which would be plagiarism. Plagiarism is the use of someone else’s work as your own without giving proper allocation and praise to the original author. Copyright infringement would be another ethical issue that deals with the stealing of the original authors of works of art, music, and other original masterpieces. There are two essential questions at the heart of any copyright infringement action: whether the plaintiff owned the copyrighted work and whether the defendant copied it (Halbert, 2012). An ethical issue that is related to the regulation of product safety is that products are being labeled correctly and have all ingrdients that are approved the Food and Drug Administration (FDA). This is aimed at different...
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...101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk Shirley Murphy, MD, and Rosemary Roberts, MD Silver Spring, Md A prominently displayed boxed warning, the so-called ‘‘black box,’’ is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and implications of these ‘‘black box’’ warnings. In this review, our goal is to provide insight into how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. We discuss drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in children, and postmarketing safety surveillance. In addition, we encourage health care providers to report drug reactions to the Food and Drug Administration’s MedWatch program. A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted. (J Allergy Clin Immunol 2006;117:34-9.) Key words: Food and Drug Administration, adverse drug reactions, MedWatch, ‘‘black box’’ warning, drug labeling, drug benefit/risk, risk management, postmarketing surveillance, drug development Abbreviations used AERS: Adverse Event Reporting System CDER: Center for Drug Evaluation and Research...
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...industry has a key role in manufacturing and developing new vaccines and drugs with an objective to improve life and prevention of diseases. Pharmaceutical industry have involvement in research and development, dealing in research and generation of new drugs, bulk manufacturing involving production of already existed drugs and in marketing. In spite of the fact that pharmaceutical industry is subjected to high risk and challenging business conditions as compared to any other industry. It has made tremendous contribution in improving global health. (IFPMA, 2012) “ Pharmaceutical industry spends more on research and development, relative to its sales revenue, than almost any other industry in the United States. According to various estimates, the industries’ real spending on drug R&D has grown between threefold and six fold over the past 25 years and that rise has been closely matched by growth in drug sales”(CBO, 2006). The research and development based pharmaceutical industries invest billions of dollars for development of a single drug and on an average the annual spending by the pharmaceutical industry is five times greater than that of the aerospace and defense industries, 4.5 times more than that of the chemicals industry, and 2.5 times more than that of the software and computer services industry”(IFPMA, 2012). IMPACT ON GLOBAL HEALTH & ECONOMY Pharmaceuticals research and drugs showed a remarkable performance in improving life, increasing life expectancy...
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...Industrial Regulation is the regulation on an entire industry by the government. This form of regulation exists to safeguard industry prices and to prevent the formations of monopolies. One of the key reasons of industrial regulation is to protect the consumer from being taken advantage of. Industrial regulation can affect the market by passing on higher prices to the consumer as a result of higher production costs. Do to the lack of competition in certain industries industrial regulation could lead to x Inefficiency in the market place. This form of regulation could also affect the market by keeping a monopoly in power long after natural monopoly conditions have expired. The regulation of natural monopolies affects the market by protecting consumers from high prices. Regulations are put into place, allowing monopolies to receive fair profits and returns on their business enterprises. The entities that are affected by industrial regulation in terms of market structure are natural monopolies and oligopolies. Natural monopolies are affected by industrial regulations through perfect competition. When you have monopolies new business are not allowed into the industry and with the firm that has the industry monopolized that one firm is the consumer’s only option. The other market structure affected is by industrial regulation is the oligopoly. Oligopoly is a group of a few large firms controlling an industry. Regulations affect this market structure by deterring the firms within...
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...Trisha Roiger Health 240: 07 FDA Regulation The Food and Drug Administration is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription, over-the-counter drugs and etc. The FDA also enforces other laws, many of which aren’t directly related to food or drugs. The FDA regulates drugs by requiring that the producers of prescription and over-the-counter drugs must demonstrate a drug's safety before it is allowed to be placed on the market. Drugs are tested by their producer for an average of 8.5 years in both labs and clinical trials (Discovery). Following these tests, the producers must file an appeal to the FDA for the drug's approval (Discovery). If the FDA approves the drug, it's classified as a prescription or over-the-counter drug. If not, the drug can't be sold in the United States. Approximately 0.1 percent of drugs tested in labs gain FDA approval. Some people may or may not agree with this procedure. Each time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA develops rules to implement the law. The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA's interest in formulating, amending or repealing a rule, and offering the public the opportunity to...
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...Abhitej Nibber YR7544 NEWS MEMO 2- Food Politics Should the FDA regulate Vitamins and Dietary supplements? How healthy are the Vitamins and Dietary supplements that promise to promote good health? Vitamins and other Dietary supplements have no set boundaries since the law that regulates this industry, The Dietary Supplements Health and Education Act of 1994 took the legal control and jurisdiction power away from the Food and Drug Administration (FDA). This law was passed in 1994 by the Congress and signed by the president and resulted in a piece of legislation called the Dietary Supplement Health and Education Act (DSHEA) of 1994.This legislation limits the FDA’s power to regulate dietary supplements. These Vitamins and Supplements have long been known to have potential serious health consequences and can also lead to death. Excess and improper consumption of these supplements can cause Liver damage, reduced bone strength, Cancer and cause birth defects. Excess of iron may lead to vomiting and nausea, harmful during pregnancy and nursing, harmful to children, increased risk of high blood pressure, heart attack, stroke and various other cardiovascular problems. The safety and health is endangered by the unregulated dietary supplements, but the dollars the industry is spending serves to dampen congressional concern over the issue,” said Ms. Sloan. “Heartbreakingly, this kind of money spending is highly usual as it has a great impact. Industries facing a threat...
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...in Marketing, Product Safety, and Intellectual Property Amanda Terry Professor: Dr. Michael Hanners LEG 500- Law, Ethics, and Corporate Governance March 12, 2015 Introduction John, a former research employee at PharmaCare pharmaceuticals, asked my law firm to represent him as a client. He expressed his concerns about his involvement with PharmaCare’s top-selling drug AD23. John and his team of pharmacists discovered that the drug could slow down the progression of Alzheimer’s. Therefore, his team reformulating the drug to maximize the effect of the drug without the approval from Federal and Drug Administration. In this paper, I will evaluate three ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety, as well as, analyze whether PharmaCare violated any of the issues in questions. I will argue the pros and cons of Direct-to-Consumer (DTC) Marketing by drug companies. I will determine which parties were responsible for regulating compounding pharmacies under the current regulatory scheme. Also, the actions that either party, or the FDA could/ should have taken in this scenario; whether PharmaCare could face legal exposure surrounding its practices. I will analyze whether or not the PharmaCare used U.S. Law to protect its own intellectual property, and if John (the client) has any claim of being the true “inventor” of AD23. I will present at least three ways the company could compensate John for the use of...
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...smoke, to the user (Mayo Clinic, 2013). Many of the manufacturers of electronic cigarettes boast the safety of these products although there are little evidence supporting that claim. Nevertheless, people continue to purchase them, and it is important to start implementing stricter policies on them. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the FDA authority to regulate the marketing, manufacture and sale of tobacco products (Products, 2013), but the original intent of the FDA is to regulate electronic cigarettes as therapeutic drug delivery devices because of the contents of the liquid. In 2010 the United States District Court of Appeals declares that electronic cigarettes should be considered tobacco products (Grana, 2013). Unfortunately, since this declaration, the FDA has not exercised regulatory authority over electronic cigarettes. A main reason for this is partly due to the government shutdown in October. Prior to this, the FDA has taken steps to provide a proposed rule to the Office of Management and Budget, which is currently reviewing it (Staff, 2013). In the absence of FDA regulation many states, localities, and the Department of Transportation have enacted their own policies to restrict electronic cigarettes, whether it be the sale to minors or the use of them in public spaces. In a 2010 hearing before the Senate Committee on Commerce, Science and Transportation, Susan Kurland, Assistant Secretary for Aviation and International Affairs...
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...The Food, Drug and Cosmetic Act was a law which was enforced to be used by United States Food and Drug administration to safeguard the health of the consumers of Food, Drug and Cosmetics in the United States. The enactment of the law was done after the disaster that happened in 1937 due to the consumption of Elixir sulfanilamide which resulted in the death of public due to its toxicity effect. The disaster happened because of the use of Polyethylene glycol as a solvent to dissolve the sulfanilamide which resulted in the toxicity of the medicament. The medicament was not tested for its toxicity studies and Pharmacological studies which resulted in failure to determine its toxic effects. So, the consumers of the medicine died of severe toxicity. Thereafter in 1938 the Federal government passed this law to ensure that the manufacturers perform all the required tests on the products manufactured so that they are...
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...Dietary supplements, according to the Food and Drug Administration (FDA), are vitamins, minerals, herbs, amino acids, enzymes, concentrates, or extracts. Using them multiple times a week, these supplements could be a way to maintain a healthy lifestyle. Americans use dietary supplements as a way to receive results instantly by ingesting many forms of supplements for things ranging from increased memory to hair growth. Some people might see it as a relatively cheap and convenient way to help relieve issues without the use of prescription drugs, but they must wake up...
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...A. Sherman Act (1890) is meant to prevent activities that a business may do that the federal government regulators believe to be anticompetitive. The Act maintains that the federal government is to examine and track trusts, companies, and organizations suspected of being in violation. It was the first federal statute to limit cartels and monopolies. (Sherman Antitrust Act, 2014) Clayton Act provides clarification to the Sherman Act of 1890. It is meant to encourage competition with businesses within the United States, discourage formation of monopolies, and prohibit price discrimination, price fixing and unfair business practices. (Clayton Antitrust Act, 2014) Robinson-Patman Act (1936) prohibits a business from selling the same item to one company for a different price while selling the same item to another company for a different price. This protects smaller businesses by limiting the large company's ability to command discriminatory discounts through its purchasing power. (Robinson-Patman Act, 2014) Federal Trade Commission Act enforces the other three antitrust laws by preventing unfair competition and deceptive practices. This act discourages businesses from entering into unlawful competition. B1. Industrial regulation deals with the government regulation of a business pricing in certain markets. It helps to decrease the control of oligopolies, prevent conspiracy and increase competition among companies. This regulation helps the consumer know that oligopoly...
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