...The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter. When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the drug proves to be effective and safe, the FDA will approve it. However, the FDA requires some drugs to be furthered studied and require additional clinical trials. When the drug is officially approved, the FDA sends an approval letter to the company- this process may take many years. Some important steps taken for an approval are (2008 Internet Drug News Inc.): Synthesis & Purification - FDA estimates that it takes approximately eight-and-a-half years to study and test a new drug before it can be approved for the general public. This estimate includes early laboratory and animal testing, as well as later clinical trials using human subjects. Animal Testing (short term) - Generally, two or more species (one rodent, one non-rodent) are tested...
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...Professor Lodge UNIV 200 14 April 2011 Ensuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration The Food and Drug Administration (FDA) 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 foods, medical devices, and prescription and over-the-counter pharmaceutical drugs (medications). The FDA regulates and supervises medical devices and drugs throughout their development, manufacturing, process of approval, marketing, and post marketing stages. When a drug or medical device is granted approval by the FDA, it will shortly become marketed in the United States and available for public use. The FDA responsibility during this post marketing stage consists of ensuring product safety and efficacy through continued research and testing of the product. If the FDA discovers safety or efficacy problems with the medical device or drug, they are also responsible for removing the product off the market and informing the public of their findings. The FDA is a very powerful United States government agency, who plays a crucial role in American citizen’s health and well-being. Through their legal authority established by the United States government, the FDA is chiefly responsible for ensuring the American public’s health and safety in the foods we eat, to the medicines we take to cure a common cold, to the treatment choices we use to help...
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...Food and Drug Administration Almost Everyday grocery stores all around the world are filled with many customers looking to buy goods. Is the FDA administering food unhealthy to humans? The answer to this question varies among so many people, as all of us have different views on how the FDA system works. The FDA is allowing these foods to be sold. In my opinion, the food is very unhealthy. Although, many people like anything they can get their hands on and sometimes that is always not the best choice. People have so many concerns whether food is unhealthy or not, it is always hard to find good and healthy food, but FDA is not one of them. Most of the food is non-organic and has GMO in it. That is why a lot of people get sick more than usual ,because of the chemicals that the individual is putting in their body....
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...The Food And Drug Administration has made a rule that requires motor carriers and shippers to make sure that vehicles are cleaned and properly-refrigerated when they are transporting food. Doug Morris is the OOIDA Director Of Safety And Security Operations. He has stated that the changes are something that they have been working on since January 2013. He also stated that these are major changes dealing with the housing, shipping and production of food. The Food And Drug Administration Modernization Act sets requirements for carriers, loaders and shippers who are involved in transporting both human and animal food. People are required to use the proper sanitary practices in order to ensure that food is safely transported. The rule specifically...
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...he United States Food and Drug Administration (FDA) is a regulatory body vetted by the US Federal Government. It is responsible for securing the safety of its citizens and livestock in the realm of consumables like food, medicines, chemicals and all of their biological delivery methods. The FDA charter, by default, makes it intimately tied to various industrial and economic entities within the United States. Since the United States is the principal world leader in economics, the FDA is often viewed as the most efficient, thorough, and authoritative food and drug organization in the world. While the US FDA oversees the majority of food and medical innovation internationally, it is not the only world class regulatory department actively engaged in the safety of the world’s population. Comparable government committees throughout the industrialized world have matching, if not higher, standards than the US FDA. Without the “red tape” associated with...
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...risks. Here I am about to tell my readers important information that you can share with your family and friends about Dietary Supplements! Dietary supplements refer to vitamins, minerals and other substances available in the form of a pill, gum, lozenge, drops or injections and intended for human consumption. Dietary supplements are available at health food stores, vitamin shops and even in doctor's offices. While their purpose is to provide health benefits, supplements should never be used as a substitute for nutrients found in foods or medication prescribed by your doctor. Dietary Supplements are vitamins, minerals, and other less familiar substances — such as herbals, botanicals, amino acids, and enzymes (see box at right). Dietary supplements are also marketed in forms such as tablets, capsules, soft gels, and gel caps. Some benefits of taking Dietary Supplements are some supplements may help to assure that you get an adequate dietary intake of essential nutrients. However, supplements should not replace the variety of foods that are important to a healthful diet — so, be sure you eat a variety of foods as well. Unlike drugs, supplements are...
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...into two categories: dietary supplements and cosmetics. Dietary supplements are products that are ingested, such as dried herbs, teas, tinctures, capsules, and tablets. These must meet regulatory requirements for processed foods as well as those listed below. Cosmetics are products that are applied to the human body for cleaning or body care. Fresh culinary herbs are exempt from these regulations. Information on selling fresh herbs can be found in the Fresh Fruit and Vegetable Fact Sheet. Washington State law abides by the federal food, drug, and cosmetic act and with the federal trade commission act that expressly outlaws the false advertisement of food, drugs, devices, and cosmetics. For more information, please see the Washington State Food, Drug, and Cosmetic Act (RCW 69.04) which outlines the regulations governing the sale of dietary supplements and cosmetics at http://apps.leg.wa.gov/RCW/default.aspx?cite=69.04. In this fact sheet, we will review the regulations for: • dietary supplements definition; • dietary supplements safety and claims; • labeling dietary supplements; • definition of cosmetics; • federal regulations for cosmetics; and • cosmetics claims. Dietary Supplements Definition The State of Washington follows the Food and Drug Administration (FDA) definition of dietary supplements. These are considered products (other than tobacco) that are: • Intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a...
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...sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval. (FDA U.S. Food and Drug Administration, 2013). 2. Post-marketing control- According to "FDA U.S. Food and Drug Administration" (2013), Post-market surveillance is an assortment of processes and activities the FDA uses to screen the safety and efficiency of medical devices once they are on the market. These actions are designed to produce information to rapidly identify below par performing devices and other safety glitches, precisely characterize real-world device performance, clinical outcomes, and facilitate the development of new devices, or new uses for existing devices. 3. Consumer Education- According to "Direct-To-Consumers Prescription Drug Advertising" (March 2010), The FDA identifies three types of DTC ads: 1) reminder ads that include no reference to the drug’s purpose, benefits, or risks, and that refer to the drug’s brand name only, 2) help-seeking ads that contain information about a disease or medical condition without mentioning the drug’s brand name, and 3) product-claim ads that include both the drug’s...
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...Drug and alcohol control Name Course Institution Tutor Date Drug and alcohol control The pure food and drug act of 1906 The pure food and drugs act of 1906 was an important piece of the progressive Era registration. This act was enacted to safeguard the public against the adulteration of food and also from the products which were identified to be healthful without the scientific support. It was applied to the goods that were shipped in the foreign commerce. The main reason was to safeguard against misbranding or adulteration. The adulteration was as a result of poisonous color or flavor in food or even various ingredients that which would be harmful to the health of humans. The provisions included development of the food and drug administration that was entrusted on with the charge of testing of all drugs and foods that was meant for human consumption (Curtis, 2013). The provisions required that there be prescriptions from the licensed physicians prior to purchasing certain drugs by the patients. There were also requirements for the label caution for drugs that are addictive. In case a distributor or a manufacturer were caught offending this enforcement they were liable for prosecution by the central government. However distributors were not entirely liable to this action if they could show a sufficient guarantee from the vendors (Curtis, 2013). The pure food and drug act also required that certain drugs inclusive of alcohol, heroin, cocaine, cannabis and morphine...
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...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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...International Legal and Ethical Issues in Business Abstract In this assignment, we will review two scenarios of business practices and how these practices influence consumers. We will also explore antitrust laws and the fact that they were established to protect consumers and businesses from anti-competitive business practices. The foundation of a dynamic economy is free and open trade. The benefits of lower prices and higher quality products or services is done through aggressive competition. To maintain this dynamic economy the United States Congress established and passed the first antitrust law. This law was named the Sherman Act of 1890. Two other antitrust laws have been passed since. In 1914 the Federal Trade Commission Act was created by the Federal Trade Commission and the Clayton Act. These laws are still in effect. The antitrust laws were created to promote competition that is dynamic and to protect consumers from mergers that would create anticompetitive business practices. These laws are enforced by the Federal Trade Commission working with the Bureau of Economics. (Guide to Antitrust Laws, 2015) The Sherman Act banishes any monopolization or attempts thereof. The Supreme Court decided long ago that this act doesn't prohibit every restraint of trade. I only prohibits those that are unreasonable. For example, two people that may want to form a partnership may restrain trade but this is not considered unreasonable. Examples of illegal...
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...Under the Federal Food, Drug and Cosmetic Act (FDCA), a company is required to specify the intended uses of a product in its new drug application to the Food and Drug Administration (FDA). Abbott Laboratories admitted that from January 1998 to December 2006, they illegally promoted a prescription drug for uses not approved as safe and effective by the FDA. Abbott Laboratories misbranded the drug Depakote by promoting it to control behavioral issues in dementia patients and to treat schizophrenia. A Virginia state federal judge fined Abbott $500 million dollars after the pharmaceutical company pled guilty to this crime. Abbot was also forced to forfeit about 200 million dollars to the Medicaid Fraud Control Unit, and could also be subject to a five years probation period. Under the terms of their probation, Abbott’s CEO and board of directors will need to personally certify that the company is complying with the law. Abbott, to date, has paid the second-largest criminal fine for a single drug. This white-collar (corporate) crime reached its conclusion on or around May 7th of this year, yet I never saw it on the nightly news along with the murders, stabbings, or robberies. I think partly because the media and/or the government try to keep these types of crimes hush-hush. As it would lessen the general public’s faith or trust in corporate America. Consumers normally purchase goods from entities that they are familiar with and/or trust, and to damage the trust of a company’s...
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...MGMT 368 Business Ethics Week 4 Deontological Second Paper April 15, 2012 Direct-to-consumer drug advertising - Deontological Point ofView For many years, consumers relied and depended on the expertise and knowledge of physicians to make decisions on their pharmaceutical needs. Before 1985, prescription drugs could not be advertised directly to consumers. The U.S Food and Drug Administration passed a rule that allowed Direct-to-consumer drug advertising in 1985. This ruling was passed on the condition that warning information was provided about side effects and other dangers. “Directto- consumer advertising is the promotion of prescription drugs through newspaper, magazine, television, and internet marketing. Drug companies also product a range of other material, including brochures and videos, that are available in doctors office or designed to be given to patients by medical professions or via patient groups.” ("Source Watch") Currently the United States and New Zealand are the only two developed nations that allow direct-to-consumer advertising of pharmaceutical drugs. Other nations feel that direct-to-consumer advertisements are often just sales pitches that pressure doctors to make unnecessary prescriptions. ("Prescription drug ads") I favor direct-to-consumer advertising/marketing of pharmaceutical drugs and believe that it is ethical. In this paper I will be using the deontological ethics of Immanueal Kant' s Theory to support my reasoning. Immanuel Kant...
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...Thesis: One of the biggest agencies within the U.S. Department of Health and Human Services is the Food and Drug Administration (FDA). The Office of the Commissioner and four directorates administer the core functions of the agency which are medical products and tobacco, foods and veterinary medicine, global regulatory operations and policy, and operations. While being a huge, big named agency designed to protect and provide public health; there are necessary regulations and guidelines to ensure the purpose of the agency is being met. This paper will explore the needs, stakeholders, expected outcomes, and other regulatory action and implementation of the FDA. Introduction: The Food and Drug Administration Safety and Innovation Act (FDASIA) is a regulation which was proposed by The Food and Drug Administration (FDA or Agency) to establish a list of “qualifying pathogens” that are likely to cause serious harm to public health. FDASIA utilizes the agency’s ability to protect and improve public health by giving the authority to collect user fees, promoting innovation, increasing stakeholder involvement, and enhancing the safety of the drug supply chain. Methicillin-Resistant Staphylococcus aureus (MRSA) is a “staph” germ that does not improve with the first-line antibiotics that typically cure staph infections. When this takes place, the germ is “resistant” to the antibiotic. This class of antibiotics includes penicillin, amoxicillin, oxacillin, methicillin, and others. (MRSA...
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...Well Being Hospital Well Being Hospital Well being hospital is looking to buy drugs from Get Well Drugs Pharmaceutical. As an administrator at Well Being Hospital, it is my job to ensure that we are making the right decision in buying drugs from this company. I have to make sure that this is the right decision for the hospital and the patients we serve. FDA As the administrator I am to find out the details on the drugs that will be purchased from Get Well Drugs. I have to ensure that the drugs that will be bought meet the standards of the Food and Drug Administration. The FDA is responsible for regulating the safety and effectiveness of drugs sold in the United States (Thaul, 2012). The FDA require that drug manufacturers meet the minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product (Thaul, 2012).A drug can not be sold in the U.S. legally if it is not FDA approved. Even after approval the FDA still watch the drug to ensure safety and effectiveness and if it fall below standards it will be removed (Thaul, 2012). In order to gain any information on the drugs being bought for the hospital I will have to communicate with Get Well Drugs. I will ask that they release all information gained from the FDA clinical trials. Finding the Facts First I will contact the company by phone. In that conversation I will inform the company that I am...
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