The Legal And Ethical Implications Associated With Wrongful Off Label Prescribing

We (Individuals) do not want an individual in jury duty under the use of illegal dugs. But, what if the individual is actually under prescription drugs?

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

Corporations and business organizations have to face lawsuits due to breach of different laws i.e., consumers laws, copyright laws, compensation laws, security laws, antitrust, employment or environmental laws. For violating any of these laws companies have to pay fines and even go bankrupt. Current paper is a report on one such lawsuit that caused GlaxoSmithKline loss of billions of dollars. The author selected "Avandia Lawsuit" to focus in this report. Avandia is a drug used to treat type 2 diabetes and was prepared by GlaxoSmithKline which was approved by U.S Government in 1998 and became best selling drug. Company generated profit through its sale but soon complains arose due to increasing incidences of heart disease and stroke as side effect of the drug.

Relators brought a qui tam action on behalf of the United States and various states against Solvay Pharmaceuticals, Inc. (“SPI”) and its affiliates pursuant to the False Claims Act. Relators alleged that SPI had marketed drugs for conditions other than the conditions for which the drugs were approved by the FDA and offered kickbacks to physicians who prescribed these drugs. Relators moved for summary judgment on a number of SPI’s affirmative defenses,

The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.

The Brazilian pharmaceutical market is the ninth largest in the world and the second among the BRIC countries (First is China, with Russia and India occupying third and fourth), annually handling about R $ 28 billion, a growth trend. Among the six largest pharmaceutical companies in the world, four are Brazilian. Currently there are about 540 pharmaceutical companies registered in Brazil.

One ethical issue which raised its head a few years ago and has resulted in changes to the way medication is administered was the covert crushing of medications and adding them to jam or other foods to disguise them when an individual declined to take their medication.

The Medicines Company Case Write-Up: Terence Cho, Felipe Duarte, Aleks Loiko, Robert Shaw, and James Wang

In this paper, I will cover ethical issues within the pharmaceutical industry, present opinion on Direct-to-Consumer marketing by drug companies, determine the parties responsible for regulation of compounding pharmacies, PharmaCARE used U.S. law to protect its own intellectual property, summarize at least one current example of intellectual property theft, analyze the potential issues surrounding the death of John’s wife, and lastly present major arguments that John can claim as a whistleblower.

Rising drug price is a typical issue in the business world and is closely related to ethical questions. The article named “Mylan CEO Faces Tough Questioning in Congressional EpiPen Hearing” from the business section of Wall Street Journal revealed the ethical issues behind the rising price of drugs. Over the past 9 years, Mylan raised the price of EpiPen which is an emergency treatment for allergy 17 times by nearly 548%. Although Mylan’s CEO argues that the company actually profits far less than the list price, their behavior should be considered unethical. As a health company, Mylan has the responsibility to improve patients’ living conditions and saving their lives. However, the dramatic increase in the price of an originally inexpensive

Substandard, counterfeit, and falsely labeled medicines appear identical to genuine medicines. They fail to treat the disease for which they were intended, putting patients at risk. The harm done to the patient to meet the greed of the surgeons and pharmaceutical companies would be pro rata to the latter's immoral propensities.

The pharmacy business and healthcare in general is an immensely complex subject with profound ethical, economic and political intricacies and considerations. As discuss previously in this paper a lot of the issues with Shkreli arise from his own personality and a lack of moral turpi-tude. For the purpose of generating a reasonable solution we will put Shkreli’s personality aside and examine the specific strategy and conditions in the healthcare space that allowed Shkreli to single handedly raise the price of Daraprim by over 5000%. This section will examine the practice of trolling, a strategy used by Martin Shkreli and Turing pharmaceuticals to profit off the drug Daraprim despite adding nothing to the development or improvement of the drug.

While recent advancements in modern medicine have turned it into a field of competition between generic and name-brand drugs, these drugs show very slight differences in ability while they have a large difference in price. The FDA is in charge of overseeing the creation of these generic and name brand drugs. Too much diversity in their results is unacceptable to FDA so they keep a close watch on the makeup and effectiveness of the drugs and how they impact the human body. Along with the differences in their chemical makeups shown by the results of each drug there are the social issues that accompany the name-brand and marketed drugs vs. the generic drugs which are never advertised and only sold. The idea that and almost identical product

It has been estimated that most of the major pharmaceutical companies have engaged in some unusual practices to keep generic equivalents of their products from entering the marketplace. These measures usually have a negative effect on consumers and health care plan providers, prohibiting them from buying equally effective products at a discounted rate. The objective of the major pharmaceutical companies in attempting to prevent generics from entering the market is clearly to provide their shareholders with exceptional profits. Some would argue that there is a morality argument to be made against “big pharma” in these cases of market manipulation. We will explore the moral

“One of the best things that Congress ever did we believe was create the drug approval process that set up a process for drugs to be approved as safe and effective by the FDA and manufactured under very strict manufacturing controls with very stringent marketing controls and regulations by the states, physicians and pharmacies” (108th Congress 1st Sess., 2003, p. 16).