...ethics as: * Ethics is the systematic study of what is right and good with respect to conduct and character. * The beliefs and behaviors to which members of the profession subscribe. * A critical evaluation of assumptions and arguments. * A discussion about what ought to be done or ought not to be done. Using Merrill’s’ definitions as a rough guide we can evaluate the legal and ethical decisions of PharmaCARE’s use of the diabetic drug AD23 in slowing the progression of Alzheimer’s disease. The drug was reformulated to maximize its effect on Alzheimer’s treatment however, PharmaCARE took actions to avoid the Food and Drug Administration in the reformulated drug for Alzheimer. PharmaCARE setup its own pharmacy company CompCARE to sell the new formulation to the public. CompCARE was able to take advantage of PharmaCARE’s databases, networks, and sales and marketing expertise to create a high demand of the product. Once the high demand was there, CompCARE started to advertise AD23 directly to consumers and marketing the drug directly to hospitals, clinics and physicians. After the success of AD23 CompCARE was sold to WellCO. Two weeks later AD23 was linked to 200 cardiac deaths. Research three to five (3-5) ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety and examine whether PharmaCARE violated any of the issues in question. Multinational Corporations have grown to the point where their wealth can...
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...and therefore it is difficult to predict a child’s response to a drug. This was one of the main reasons children were not included in drug trials until recently. Absence of regulation that required drug companies to conduct trials in children, and lack of facilities, equipment/technology, and expertise were also challenges that discouraged drug testing in children. In addition, there were numerous ethical concerns which involved fears of harming children and increased liability issues (The Necessity and Challenges of Clinical Research Involving Children, 2004). As a result, children did not receive potentially lifesaving or beneficial treatment when needed. Clinical trials in children are critical because they provide information on the drug’s safety, dosing, and effectiveness (Drug Research and Children, 2011). Prior to the 1990s, the FDA did not acquire legislation related to investigating drugs in children. The Pediatric Rule of 11994, mandated drug labels to consist of instructions for children, however it proved to be fairly ineffective since the information used on these labels was based on adult dosing and trial and error in pediatric patients. In 1997 the Food and Drug Administration Modernization Act (FDAMA) was established. The act did not require pediatric testing, but offered an incentive for drug companies by granting an additional six months of marketing if the company chooses to test its own drug in pediatric clinical trials. This allowed companies to increase...
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...The 1997 Food and Drug Administration Modernization Act (FDAMA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to include several new provisions added by Congress. One provision is the requirement that sponsors of approved drugs and biological products, report on the progression of Post Marketing Requirements (PMR) and Post Marketing Commitments (PMC) annually. Section 506B of FDCA authorizes the FDA to track and monitor the progress of PMR/PMC to ensure completion in a timely manner. FDA accomplishes this task by reviewing Annual Status Reports (ASRs) submitted by the sponsor for completeness and accuracy. Sponsors of approved drugs and biological products that have entered into an agreement to conduct a post marketing study or trial...
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...Programs Susan Thaul Specialist in Drug Safety and Effectiveness Domestic Social Policy Division Summary By statutory requirements and by regulation, guidance, and practice, the Food and Drug Administration (FDA) works with several overlapping yet distinct programs to get to market quickly new drug and biological products that address unmet needs. FDA most frequently uses three mechanisms for that purpose: Accelerated Approval, Fast Track, and Priority Review. The first two affect the development process before a sponsor submits a marketing application. Accelerated Approval allows surrogate endpoints in trials to demonstrate effectiveness and is relevant in fewer situations than the others. The Fast Track program encourages a sponsor to consult with FDA while developing a product. Unlike the others, Priority Review involves no discussions of study design or procedure; it relates only to an application’s place in the review queue. Analysis of total approval time for approved applications under the Fast Track and Priority Review programs shows that for seven of the past nine years, Fast Track products have shorter median approval times than do all those applications assigned to Priority Review. It takes an average of 15 years from the moment a manufacturer first approaches the Food and Drug Administration (FDA) with an idea for a new drug to its final approval for marketing.1 Steps in the development and approval of a drug or biologic (e.g., a vaccine) involve...
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...Unethical Marketing of Prescription Drugs: Misleading Direct-To-Consumer Advertising and Disease Mongering. October 3, 2011 Unethical Marketing of Prescription Drugs Introduction The purpose of this ethical paper is to investigate the marketing tactics being used by pharmaceutical companies and discuss the ethical issues involved. The primary source of information discussed in this paper was gathered from analysis of business and scholar journals, case studies, and current news articles. The main focus of my research was placed on the unethical practices of pharmaceutical companies and the current marketing regulations in the United States. The unethical practices primarily covered in this paper include disease/fear mongering, and the misuse of direct-to-consumer & physician-directed marketing to increase the profits of pharmaceutical firms. But before we get into the unethical practices taking place in today’s pharmaceutical industry, let’s take a look at the idea of ethics. So, what exactly is ethics? Merriam-Webster defines ethics as “the discipline dealing with what is good and bad and with moral duty and obligation,” and “a theory or system of moral values” (Merriam-Webster, 2011). As you can see, this is a complex but vague definition to say the least. In today’s world of international business where firms operate across cultural boundaries and face stiff competition in the fight for profits, it’s even more difficult to clearly define the meaning of...
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...U.S. Food and Drug Administration (FDA) drug review bears a structural similarity to many decisions made by other regulatory agencies: high uncertainty, low reversibility, avoidance of observable error, and high political stakes that induce lobbying by interested parties. This project explores the policy lessons to be learned from viewing FDA drug review as a politically shaped exercise in information processing. I argue that the incentives facing regulators induce limits on the degree to which drug review can be accelerated, that the same incentives could render privatization initiatives problematic, and that political pressures could play a useful role in identifying priority drugs. Patients, more than pharmaceutical firms, shape the political costs to the FDA of delaying drug approval. Consider two hypothetical consumers, one a pharmaceutical consumer (“patient”) who wishes to try a new drug for some ailment, the other a vitamin consumer who wishes to take zinc supplements to ward off a cold or flu. There are few institutional restrictions upon the consumption decisions of the vitamin consumer, at least in the United States. She is free to purchase vitamin products over the counter, and the vitamin manufacturer is free to sell them without prior authorization or licensing. Not so with pharmaceuticals. The marketplace for pharmaceuticals is one of the most highly regulated industries in the U.S. economy.1 To use any new pharmaceutical product, the patient must secure the...
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