...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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... a licensened physician and the principle investigator of the study, along with Lisa Sharp, the director of clinical trials at Lee Research Institute were named in the inditement.Dr. Spencer and Sharp were each charged with one case of conspiracy, three counts of mail fraud, and one count of falsifying information required by the Food and Drig Administration (Pharmalot.com, 2011). Dr. Spencer and Sharp were terminated by Lee Reasearch Institute following the inditements. Lee Research Institute immediately started an internal investigation of the alledged insedence in cooperation with the Food and Drug Administration and Schring/Plough (Kansas City Business Journal, 2011). The indictment accuses the two former employees of providing false information of the patients participating in the study trials. The study was to be conducted using subjects 50 years old or greater who suffer from ragweed allergies. Employees of the contracted research organization were prohibited from participation in the case study. Dr. Spencer and Sharp are accused of falsifying the information of the participants. Eight individuals participated in the case study. The researchers stated all eight met the requirements of the study (Pharmalot.com, 2011). Two of the participants were not over the required age of 50 and were employees of the contracted research organization. The indictment alleges that Dr. Spencer and Sharp reported to the Food and...
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... Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property Legal 500 Professor Carter Introduction In the book Pharmaceutical Ethics, Jon Merrills’ defines 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...
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...box’’ 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...
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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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...by Fred Sand Professor Newcomb, Legal – 500 February 27, 2014 compared The remainder of the document will discuss and examine law suites held against PharmaCARE and various ethical dilemmas the company may encounter. On August 17, 1997, executives around northern New Jersey’s drug corridor, where most of the international Pharmaceutical companies have their headquarters, mobilized for action” (Aitken & Holt, 2000, p. 82). According to Aitken and Holt (2000), this was the day that the US Food and Drug Administration issued temporary guidelines the, for the first time, permitting the drug makers to specify the uses of their prescription remedies in their radio and television advertisements (p. 82). Marketing and advertisement has been around almost since the beginning of time. One of the ethical dilemmas concerning television and radio advertisements for prescription drugs is the potential for the consumer to self-prescribe or evaluate their symptoms. According to the U.S. Food and Drug Administration (2013), doctors believe that patients understand that they need to consult a health care professional about appropriate treatment (p.1). On the other hand, it could be possible for the patient to adapt their own symptoms for the sake of obtaining a desired medication. “Intellectual property (IP) is the work product of the human mind. Novels, paintings, computer programs, songs and inventions are all examples” (Halbert & Ingulli, 2012, p. 316). “Activist...
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...The United States department of labor is the department that oversees my job. It regulates the amount of work hours before I am due a break, and or a lunch break. They also regulate the amount of minimum wage for jobs in the United States. The United States department of labors also constitutes what is considered overtime and the wage we receive. The Department of Labor fosters and promotes the welfare of the job seekers, wage earners, and retirees of the United States by improving their working conditions, advancing their opportunities for profitable employment, protecting their retirement and health care benefits, helping employers find workers, strengthening free collective bargaining, and tracking changes in employment, prices, and other national economic measurements. In carrying out this mission, the department administers a variety of federal labor laws including those that guarantee workers’ rights to safe and healthful working conditions; a minimum hourly wage and overtime pay; freedom from employment discrimination; unemployment insurance; and other income support. ("United States Department Of Labor", 2012). United States Department of Labor’s mission is: To foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States; improve working conditions; advance opportunities for profitable employment; and assure work-related benefits and rights. ("United States Department Of Labor", 2012). The Federal Communications...
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...age groups be vaccinated. However, more and more people are becoming concerned about the safety and the efficacy of the vaccine (Tomljenovic & Shaw, 2012). The Centers for Disease Control (CDC) recommends that all females between the ages of 9 and 26 years old receive three doses of the HPV vaccine (Cervarix or Gardasil). They also recommend that all males between the ages of 9 and 26 years old receive three doses of the HPV vaccine (Gardasil only) (WebMD, n.d.). Gardasil and Cervarix are both new to the world of medicine, only being approved by the Food and Drug Administration (FDA) on June 8, 2006 (U.S. Food and Drug Administration, 2009) and October 16, 2009 (U.S. Food and Drug Administration, 2012) , respectively. Although the makers of the vaccines, Merck & Co. (Gardasil) and GlaxoSmithKline (Cervarix), claim that the medicines prevent cervical cancer and have no serious side effects, there are no long-term studies to support those claims. This lack of evidence is a good reason for parents to opt out of this vaccination. HPV is the most common sexually transmitted disease in the United States. It is estimated that roughly, 79 million Americans are currently infected with HPV, and 14 million will become newly infected each year (CDC, 2014). There are 40 strains of HPV that are sexually transmitted, but the vaccination only covers four of those. In the majority of people who contract the virus, there are no symptoms and the...
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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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...University of Maryland Case Study Analysis Eli Lilly: Developing Cymbalta Case Study AMBA 650 Section 1131 Kelvin Harris January 24, 2012 Executive Summary Eli Lilly and Company resounding success was the arrival of Prozac in 1988. By mid-1988, a new anti-depressant team was formed to find and develop a drug that would be the successor to Prozac. The strategic issues and problems they faced were developing a new drug to replace Prozac, meeting the company budget constraints to perform clinical trials, and finally launch the new drug by mid-2001. The analysis and evaluation revealed that the pharmaceutical industry is changing fast and it usually takes a long time and millions of dollars to develop a new drug. The recommendation for Eli Lilly is to take the lead in developing the new drug Cymbalta, invest a stable share of the company revenue, seek the FDA approval for the development of Cymbalta before going to market, and not change their market plan from the FDA approved Cymbalta dosage of 20 mg twice daily. Introduction Eli Lilly and Company was founded by Colonel Eli Lilly, Lilly’s namesake, in 1876 when he purchased a laboratory on Pearl Street in Indianapolis, Indiana. Eli Lilly was a pharmacist who had served in the Union Army during the Civil War. The company success included creating the process for applying gelatin-coating to pills for easier swallowing and the introduction of Iletin which was the first mass-produced insulin. Iletin...
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...S. Food and Drug Administration must expand access to experimental, unapproved drugs to include terminally-ill patients who have exhausted all conventional treatment methods and choose to accept the risks. Terminally-ill patients deserve the right 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...
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...prescription drugs. The price of Daraprim, a drug to treat toxoplasmosis, was increased by over five thousand percent. The increase has sparked people from both the AIDS and cancer organizations to reach out and attack the ethics of Chief Executive Officer, Martin Shkreli through social media. The increase in price may prevent hospitals from having treatment available for patients who need it. The practice of price gouging prescription drugs has now become an important political topic many candidates running for President of the United States in 2016 will be talking about. Significance of a Solution Recognizing that developing, manufacturing, and marketing pharmaceuticals is a very profitable business, the case of Turing Pharmaceutical’s purchase and marketing of the drug Daraprim spotlights a potentially serious issue with the way some companies “repackage” existing drugs to create higher profit margins. Daraprim (Pyrimethamine) was originally approved January 23, 1953 for the treatment of toxoplasmosis, an infection caused by a very common parasite (U.S. Food and Drug Administration, n.d.). Because most people never exhibit symptoms of this disease, sales of this drug were very small; and, no generic drug company ever bothered to duplicate the formula (Mayo Clinic, 2015). Seizing the opportunity to “corner the market” on this drug, Turing Pharmaceuticals purchased the rights and immediately raised the price from $13.50 per tablet to $750 per tablet. As in this case, the absence...
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...Experimental Study on Hypolipidemic effect of some selected Rûksha Guna drugs SANGRAM MISHRA * R. R. DWIVEDI** B. RAVISHANKAR*** B. K. ASHOK**** Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar. ABSTRACT : Âyurveda as well as Philosophies accepted the Guna as the basic entity of the Srishti. Gunas can be classified under various categories like Âdhyâtmika Guna, Gurvâdi Guna, Parâdi Guna, Vishistha Guna. For the treatment purpose Gurvâdi Gunas are widely used. Among them the Snigdha Guna and Rûksha Guna are widely used in the Samhitâs. This study has been carried out to establish the Rûksha property drugs on animals as a hypolipidemic effect on induced hyperlipidemia animals. The drugs selected were having Rûksha property by Rasa panchaka. The drugs were Vachâ (Acorus calamus Linn), Kushtha (Saussurea lappa C.B. Clarke), Haridra (Curcuma longa Linn), Daruharidrâ (Berberis aristata DC), Chitraka (Plumbago zeylanica), Karanja (Pongamia pinnata Pierre). All the drugs are having Lekhana property and Srotosodhaka karma due to Rûksha property. Based on this promise the test drug (Rûksha Guna) had been studied on various experimental models such as body weight, weight of liver, heart and kidney, food intake and faecal out put, water intake, total faecal fat content etc. The selected drugs are the representative of highest magnitude of Rûksha property which are able to influence Dîpana and Pâchana property and the test drug was administered...
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...INVESTIGATIONAL NEW DRUG REVIEW PROCESS Investigational New Drug Review Process Prashanth Kumar Ponugoti Northeastern University INVESTIGATIONAL NEW DRUG REVIEW PROCESS Abstract Investigational New Drug (IND) review process begins from the time the sponsor files investigation new drug application and the purpose of the review is to confirm the safety and efficacy of the patient for the drug. Moreover in the process of review if the review committee notifies any deficiencies by the new drug then there will be a clinical however if there are no deficiencies the drug will be approved for new drug application and will be under continuous review to make sure , that the drug does not cause any potential harm. This entire step wise process of review is explained in the following paper INVESTIGATIONAL NEW DRUG REVIEW PROCESS The following flow chart gives an overview of the IND review process Applicant (Drug Sponsor) IND Review by CDER Statistical Pharmacology/ Toxicology Medical Chemistry Sponsor Submits New Data Safety Review Safety acceptable for study to proceed Clinical Hold Decision Notify Sponsor Complete reviews Reviews Complete and Acceptable? Sponsor Notified of Deficiencies No Deficiencies Study Ongoing INVESTIGATIONAL NEW DRUG REVIEW PROCESS I. Applicant (Drug sponsor): An applicant or the sponsor is a person or a group who takes responsibility and initiates for the investigation...
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...Danya Bocarsly Case Study #1 Patho-Pharmocalogy Mr T is a 67 year old retired Navy veteran. He has been taking simvastatin for 2 years to treat elevated cholesterolemia. During a recent visit to a 24 hour acute care clinic in a local mall he was prescribed clarithromycin for an acute sinus infection. Two days later Mr T arrives in the emergency room complaining of generalized muscle pain, muscle weakness and dark colored urine. Tests revealed myoglobin in the urine and a serum creatinine of 186 micromol/l (usual baseline for this patient was 90 micromol/l). A diagnosis of rhabdomyolysis is made. 1. Create a pharm card for each medication listed in the case. Include drug generic name, routes of administration, indication/uses, side effects, contraindications, drug interactions, food interactions, method of metabolism drug generic name routes of admin Indication/ uses side effects contra-indications drug interactions food interactions method of metabolism method of excretion...
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