...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 manage a disorder, and even the treatments available to possibly cure a disease. All of the citizens in the United States depend on the FDA to do their...
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...Food and Drug Agency’s Drug Approval Process Abstract The drug approval process of the Food and Drug Agency for pharmaceuticals is a complex and often lengthy one. Done out of necessity to ensure the products being introduced into the growing healthcare field are overall safe and effective for utilization by patients. While the process is far from perfect it still a staple in introducing innovative and breakthrough drugs into healthcare fields across the board. This paper will discuss the process encountered to get pharmaceuticals approved for manufacture and distribution to physicians and patients. Food and Drug Agency’s Drug Approval Process “For healthcare technology, the most important regulatory approval comes from the federal Food and Drug Administration (FDA)” (Williams & Torrens, 2008, pg.28). This agency approves all drugs and pharmaceuticals, medical devices, and some medical equipment. The FDA also controls access to drugs by deciding whether a certain drug will be available by prescription only or as an over-the-counter purchase (Shi & Singh, 2013, pg.115). The most well-known regulatory review of medical technology is that conducted on pharmaceutical products and to some medical devices that are subjected to detailed preliminary approvals, clinical trials, and post-approval surveillance policies. Before a drug can begin (first phase) clinical testing, the sponsor of the drug must evaluate the product’s safety and biological activity via in vitro and...
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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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...INTRODUCTION Pharmaceuticals 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...
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...to choose and have access to potentially life-saving drugs as the potential benefit of life justifies the potential risks when imminent death is their only alternative. After extensive testing many of these drugs go on to be approved, but this process can take years and often terminally-ill patients die long before FDA approval. By allowing dying patients the choice of participation in clinical trials, not only could life be spared, but the possible proven efficacy of these drugs could be of benefit to all humanity. A Patient's Right to Choose It is the constitutional right of the citizens of the United States of America to make an informed decision as to whether or not to use potentially life-saving drugs to prolong life when terminally ill. Federal regulations and restrictions must be lifted to accommodate access to this fundamental right. When faced with a terminal illness and all conventional treatment methods have failed, it should be the patient's choice as to whether or not unapproved, experimental drugs are used, as the potential benefit of life justifies the potential risks when imminent death is the alternative with no other options. Drug Approval Process The U. S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) currently evaluates and dictates when new drugs can be prescribed and dispensed to the public. According to the Food and Drug Administration (2009), when pharmaceutical drug companies want to market a new drug, it must first...
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...Eli Lilly: The Evista Project® In early 1998 Dr. August “Gus” Watanabe, executive vice president of science and technology for Eli Lilly and president of Lilly Research Laboratories (see Exhibits 1 and 2), looked out his office window toward downtown Indianapolis. He was contemplating the future commercialization path for Lilly’s new, potential blockbuster drug, Evista®, which had received FDA approval on December 9, 1997, for the prevention of post-menopausal osteoporosis. Evista®, generically known as raloxifene hydrochloride, would be entering the estrogen replacement market, a market that had worldwide sales in excess of $1 billion in 1997.[1] Of even wider significance was the fact that in initial trials, Evista® appeared to lower the incidence of breast cancer and reduced total LDL in post-menopausal women without the negative side effect profiles of currently available estrogen replacement therapies. The potential of this new therapeutic and its impact on Lilly could be enormous. Some analysts predicted that Evista® might become a $1B drug for the company.[2] With this in mind, Watanabe knew that the decision on how best to commercialize Evista® would have a profound effect on Lilly’s well-being. Should Lilly follow its traditional approach to commercialization? Or should Lilly follow a course more in line with the development approach adopted for Evista® in early 1995, which would require the organization to transform its heavyweight product...
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...Care Issues in the United States Dr. Williams HSA 500 Introduction to Health Services October 24, 2010 1. Explain how health is affected by behaviors, economics, and social structure. The level of health is affected by factors of finance, culture, geography and other influences. When on is trying to obtain medical services there are several factors that need to take place as far as having adequate health insurance coverage. If someone does not have access to a good specialist for medical care, and this is due to lack of medical insurance or dependence on the local government. Due to the geographical location if the hospital is further away for those who have lack of public transportation or lack of their own mode of vehicle it creates a problem. Also in the cultural aspects, depending on how some patients feel they may not be comfortable with the level of skills used and practiced. Some patients will and have traveled to other countries for medical care. 2. Describe the three stages of medical technology development. The three stages of medical technology are: scientific background and development of the idea for a product; product development, approval, and distribution; and, diffusion, adoption, and utilization of the product. With the first stage of the development it involves a lot of basic science discoveries that provides fertile scientific environment from which useful products may one day they will eventually emerge. Without having the first stage, of broad-based...
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...2008 FDA Fast Track and Priority Review 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...
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...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 approval of two agents:...
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...FDA review of Intrinsa suggested that there is a very high possibility of the fact that Intrinsa may be prescribed to those women who don’t have low testosterone levels or who have not underwent hysterectomy. Additionally, women who become menopausal following chemotherapy for breast cancer could be another off label user population and these high systemic testosterone levels could be dangerous in these women. [4] In case Intrinsa gets market approval in US market without getting adequate safety data, it would be very ignorant to assume that Intrinsa would not be used off label on a large scale by those women population for whom Intrinsa is not intended...
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...Business Research Ethics RES/351 Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel, oral antivirals in areas of high unmet medical need. Since 2001, the organization has researched, developed and experimentally tested a virus-killing drug called Brincidofovir. Subsequently learning of the existence of the drug, a family requested that the company donate the drug to treat their little boy who contracted a deadly virus after receiving a bone-marrow transplant. The company had distributed the drug during a three year testing period, but as the drug entered the final stages of the federal and drug administration (FDA) approval, the company ceased its compassionate care program. The establishment’s CEO reportedly claimed it has denied hundreds of requests because human testing guidelines mandate two control groups, one that takes the actual drug and the other that takes sugar pills, placing very ill people at-risk because the sugar pill is useless. As a result, the organization focused on getting the drug approved for widespread consumer use which entails denying interim requests for the drug, and presents an ethical dilemma for the company. Chimerix sought the research to find a solution to this ethical dilemma, gauging the social temperature of the people affected and risking the reputation of the organization at whole. Chimerix argued if the drug was made available to this one ill child, it could not ethically justify denying...
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...MEMO To: Borg Re: Preferred stock classification Facts Borg (the Company) is an early-stage research and development medical device company. Borg has no current products in the marketplace but is in the final stages of going to market with the Heart Valve System. All preliminary trials have been approved by the FDA, and the Company is in the final trial; once the final trial is complete, the Company will present the product to the FDA for final approval. If approved by the FDA, the Heart Valve System will revolutionize the way medical professionals repair heart valve defects. Bionic Body (“Bionic”), a SEC registrant, is a biological medical device company that focuses on the development of implantable biological devices, surgical adhesives, and biomaterials. Bionic could benefit from the approval of the Heart Valve System since it has a supplementary device that could be used in tandem with the Heart Valve System. As part of a financing strategy to support its operations, Borg sold Bionic $3.5 million of Series A Preferred Shares (the “Shares”) of the Company with a par value of $1 per Share. The transaction was completed on November 30, 2011. As part of the Series A Preferred Stock purchase agreement, Bionic has the following rights: * Board Rights — as the holder of the preferred stock, Bionic is entitled to appoint one member to the Company’s board of directors (the “Board”). In addition, Bionic has the right to appoint an observer to receive all information provided...
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...Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and steps are required to bring new drugs into the market. FDA specific guidelines for new pharmaceuticals are essential because it determines a drug’s safety and effectiveness. To support this thesis an overview of steps required to market a new pharmaceutical will be discussed as well as human testing of drugs, the role of FDA in approving new drugs, and the cost incurred by drug companies when developing new drugs. Pharmaceutical development can be divided into segments. The first segment is the preclinical phase; this is where the drug company attempts to breakdown a disease process into components so it can provide clues for targeting new drug development and usually takes three to four years to complete (Lipsky & Sharp, 2001). Once a new drug has been chosen and developed, the FDA requires that animal tests be performed. In vivo testing, typically done to rodents, demonstrates the safety of the prospective medication and also to notes and evaluates any side or toxic effects, addictions, cancerous tumors, and/or fetal deformities (Turley, 2010, p. 27). The results from the animal studies, indicating no risk to humans, will then be used to support the investigational new drug application (IND) to the FDA to request permission to test the drug in humans (Turley, 2010, p. 28). If the FDA is approves the application and documentation, the stage is set for clinical trial phases of human testing. Clinical trials of human...
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...as a noninvasive way to shatter kidney stones, the biliary lithotripter hasn’t yet received approval from the FDA. The certainty of our success is, thus, not predictable. Involvement of too many partners: Profit sharing will be difficult with twenty-five limited partnership offered to our local physicians. Lack of reimbursement for biliary lithotripter: Although the FDA has granted approval to begin clinical trials, biliary lithotripter does not still qualify for Medicare or Medicaid reimbursement. Uncertainty of clinical trials: Clinical trials may pose risks and are very costly. Safety may be jeopardized in some...
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...patients are influenced by economic issues, the special medical needs of those served, and by the Federal Drug Administration making sure that the risks and costs of the treatment don’t outweigh the benefits. The cost of cancer involves the cost of treatment, the cost of research, and the cost of FDA processes to get the treatments and drugs to the market. Even when the economy is good these are difficult things to meet. The costs of cancer treatment can be so devastating to both insured, and uninsured that cancer stricken patients sometimes decide not to take the treatments. Decisions must be made whether to pay the mortgage, or pay for treatments that may or may not cure the cancer. A cure for cancer has not yet been found .This year, about 580,350 US residents are expected to die of cancer, that’s nearly 1,600 people a day. Cancer is the second most common cause of death in the United States, exceeded only by heart disease. Cancer accounts for nearly one out of every four deaths in the United States (American Cancer Society, Last Revised: 02/01/2013,http://www.cancer.org/cancer/cancerbasics/economic-impact-of-cancer) According to the American Cancer Society, The financial costs of cancer are high for both the person with 2 cancer, and for society as a whole. The National Institutes of Health estimated the 2008 overall annual costs of cancer total were 201.5 billion dollars. The direct medical costs which were the total of all health expenditures...
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