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?

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,

Many have accused that Food and Drug Administration is not aggressively monitoring drugs prices, the FDA is in charge of regulating devices and drug production. Big Pharma spends billions of dollars annually on direct-to- consumer advertising which entitles manipulative strategies (4). The theory behind such good progress is the company attracts doctors, scientist, and other health related personnel’s. Medical research teams and doctors conduct extensive research with funds from Big Pharma. Even though many accuse Big Pharma for not following their mission statement it has not restricted them from purchasing their prescriptions medications. Big Pharma a company with many tactics and strategies, have been hiring former government workers whom have authoritative links to gain political influence. Currently, they have hired, 36 who worked for a member of Congress, 13 who worked for a federal agency, 2 who worked for the White House (4). With influenced members from Congress, they use their connection to reach their company goals. Unfortunately, U.S law permits drug manufacture companies to set prescriptions drugs prices without any restriction from the FDA. On the other hand, other countries set a limit on what companies can charge bases on the benefit of the drug (4). There are many hidden facts, which Big Pharma does not reveal; for example, the company spends double the amount of advertising then they do on research. Persuasion is the key to pharmaceutical industry, paying physicians/surgeons to incorporate their names on research articles, with the intent of getting published in

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.

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.

Many people see the drug price increases made by Martin Shkreli of Turing Pharmaceuticals of the toxoplasmosis drug Daraprim by 5000%, or, the EpiPen’s 400% price hikes as being immoral, unnecessary, and just price gouging, but others and I argue that the increases are well justified and really not detrimental to consumers. Dr. Nitin Damle of the American College of Physicians had this to say on the matter to members of congress, “The research, development, regulatory, and payment systems for prescription medication are deeply intertwined, and the pressing issue of drug pricing and payment will require comprehensive efforts not only by Congress,

The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” ("What We Do."). One of the most important responsibilities and the topic I will be discussing throughout this paper is drug regulation. The Food and Drug Administration approves drugs that are intended for use in diagnosis, cure, relief, treatment, or prevention of disease, and is intended to affect the function of the body. In order to do so, The Food and Drug Administration reviews drug manufacturer’s via application to put drugs on the market; therefore, a drug may not be sold or marketed unless it has and remains approved by the FDA. Even though a drug has been approved does not mean it will remain on the market, drugs have the likelihood to be recalled. For example, when you see those late night personal injury lawyer commercials saying, “If you have been prescribed and taken said drug, and experienced any of these side effects such as blood clots, seizures, etc., you may be entitled to compensation.” those drugs have usually been recalled due to adverse effects

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.

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.

Over the past couple of decades, a sudden change has started to take over the way business is done. The time when no rules applied, and anyone could do what they pleased at the cost of others or the environment is rapidly ending. Instead, companies today have become aware that it is essential for them to employ ethics and morality in their actions, if not they will be heavily scrutinized and rejected by the public. This way of thinking also applies to the pharmaceutical industry, which over the past century has been rapidly expanding. Do to the fact that this industry can determine the health and lives of millions of people, it is imperative that this industry follow an ethical and moral path.

Drug misuse can be defined as the use of a drug’s medical properties for wrong indication, wrong dosage or for duration longer than that is recommended. Drug dependence is a situation where one is fully addicted or dependent on a drug. Drugs available to the public from pharmacy outlets can either be over the counter (OTC) drugs and prescription only drugs (POD).

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.

The current regulations governed by the FDA are very strict and should remain that way because the base of these regulations are underlined by various tragedies which we don’t want to be repeated. For instance, the thalidomide incident in which many children were born with Phocomelia (shortening or absence of limbs). Thalidomide, which started as an OTC drug in 1957 as a remedy for sleeplessness was later found to have off-label effects such as mitigation of morning sickness in pregnant women. Hence was then prescribed worldwide to pregnant women. However, in 1962 Frances Kelsey prevented the approval of this drug in the USA. This resulted in Harris-Kefauver Amendment in 1962 which tightened the investigation and approval of drugs requiring the manufacturers to prove their safety and efficacy. Many incidents could be avoided in the past if the regulations were firm and so there is an utter necessity of governing bodies for oversight of clinical trials, new drug development and manufacturing of drugs, biologics and medical devices.

When London-based GlaxoSmithKline (GSK) paid a $750 million dollar settlement as part of a plea agreement that required it’s Cidra, Puerto Rico subsidiary SB Pharmco to plead guilty for knowingly selling contaminated medicine, it laid to rest any doubts that its business practices were in direct conflict with its commitment to both quality and to creating a strong ethical culture. There are, nevertheless, important issues that extend beyond the facts in evidence. This paper does not seek to re-litigate the government’s case against GlaxoSmithKline. It, instead, seeks to accomplish three basic goals: to offer insights into the failure of the Food and Drug

This is the largest sum paid by a pharmaceutical giant for settlement of fraud charges in the US history. But in Glaxo’s case what gets especially highlighted is its marketing ethics. The charge against its sales force was of bribing physicians for prescription of its drugs. The sales force of GSK offered the physicians incentives to prescribe GSK products as well as free holidays and tours along with additional funds to go on speaking