Introduction Business ethics is an extremely important topic in our world today. This is especially true because of the fact that we live in a changing society where it has become increasingly common to see more and more cases of companies that participate in illegal, immoral and unethical activities. So that we can prevent these behaviors, it is necessary to study and understand how these situations can occur and what we can do to prevent them from happening. In this research paper, we will examine in detail the case of KV Pharmaceuticals, also known as KV. We will discuss a few major areas of topic that include how and why these events took place, as well as what could have been done to prevent them. Next, we will take a look at …show more content…
One month later, KV decided to recall some of the morphine sulfate it had distributed, and it also filed a field alert report to the FDA informing them about their recall. KV immediately began an internal investigation of their manufacturing process and their products; the investigation revealed that not only were the morphine sulfate pills oversized, but the propafenone and dextroamphetamine sulfate tablets as well. These oversized tablets can result in the patients receiving almost twice the amount of the recommended dose, which can lead to fatal consequences. Propafenone is an anti-arrhythmic medication that treats illnesses associated with heart palpitations. An overdose can cause low blood pressure or heart palpitations which may lead to death. Dextroamphetamine sulfate is used to treat narcolepsy, ADHD in children, epilepsy and parkinsonism; an overdose can lead to fatal poisoning (KV Pharmaceutical, 2010).
The complaints led to the inspection of KV by the FDA from December 2008 to February 2009; the inspection results confirmed that KV Pharmaceuticals had a considerable amount of cGMP violations, and even then they decided to manufacture unapproved drugs. While conducting the inspection, the FDA also realized that ETHEX had never filed the field alert reports concerning the oversized propafenone and dextroamphetamine sulfate tablets, which is required under the Food, Drug, and Cosmetic Act. This Act states that drug manufacturers must carefully
Business Ethics are defined as “moral principles that guide the way a business behaves” (Businesscasestudies, 2017). In order for any business or individual to act in an ethical
The author Robert Solomon argues that ethics has to an integral part with regard to business management. He does not believe that business management must include unethical or illegal methods to be able to succeed. Solomon preaches that business management is not as simple as obtaining revenue. “Businesses need to abide by fair policies and their owners have to be ethical in dealing with their customers” (Shaw p. 37). The author acknowledges that while illegal practices in business management could bring positive results at first, eventually the business is bound to fail. This is why Solomon recommended eight important policies that can help businesses in integrating ethics into their operations.
As consultant to Sanders and Myers, I would suggest they rethink the continuation of economic value added (“EVA”) bonus payout process. The proposed EVA bonus payout structure is supposed to be an objective way to gauge and reward employee performance; however, through no fault of their own, the Dermatology group is slated to undergo severe ebbs and flows in their incentive and could potentially wreak havoc on employee morale and retention.
Prior to 1978 the pharmaceutical manufacturing was highly regulated, drug product quality and sterility testing was based solely on finished product testing i.e. it was tested only at the final stage of the release drug product this was clearly a major setback. For Sterile products – USP Sterility Testing was the sole criteria for releasing the drug product in to the market. The following incidents shows
The problem to be investigated is the application of business ethics. In the business world, ethics are extremely important. Ethics are prime elements that help a business to grow and to become more productive. It is by applying proper business ethics that a business can operate in a moral or ethical business environment and managed to conduct all activities in a manner that maximizes profits while not compromising all other non-economic concerns(Schwab, 1996). Businesses have over the years failed to nurture business ethics in order to fulfill shareholders' interests and to have a culture that is oriented towards profit maximization and high performance(Jennings, 2012; Sims & Felton, 2006). This has led business to have gray areas in their activities. Gray areas are those situations or problems that do not fit exactly into any ethical analysis. These are the activities which may be represented to be immoral as a result of lying and false representations on the part of the business.
This will be an over view of ethics as it relates to business in our society. Concepts from Philosophy will seek to describe the correlation between actions that are classified as morally right or ethical in our dealings with each other as human beings. Clear and concise examples will be given as well as ways in which to improve upon business ethics.
Business Ethics is a set of moral principles applied in the commercial world. Business ethics provide guidelines for acceptable behavior by organizations in both their strategy formulation and day-to-day operations. An ethical approach is becoming necessary both for corporate success and a positive corporate image. Following pressure from
A company like Teva Pharmaceuticals is subject to all of the factors of the external environment given the nature of its business and global expansion. Pharmaceuticals is an industry where high profits can be achieved, but it is also an extremely challenging business when one considers all of the political/legal aspects involving government regulation and patents. Every country has strict regulation and testing requirements for drugs that affect companies differently depending on their position in the market. Originally, innovative pharmaceutical companies had to obtain patent protection and FDA approval but this would translate to years of protection from the generic competition. Once the
(Panza & Potthast, n.d.) Ethics is very important to a company’s success. Ethical behavior can bring benefits to a business. They can attract customers, which can lead to a boost in sales and profits. It can attract the right employees and increase productivity. It can also attract investors and keep the company’s share price high. Unethical behavior on the other hand can damage a company’s reputation and make it less appealing to stakeholders. It could also result in lower profits.
A recent FDA regulators report is saying that Johnson & Johnson “still hasn't solved all the problems at the Pennsylvania plant largely responsible for a huge recall of children's medicine earlier this year.” Plant operations have been suspended as Johnson & Johnson performed in depth review of its manufacturing processes. However, finance reports from FDA investigators on recent inspection conducted in the plans have revealed again problems on manufacture control. The main failures are in establishing control procedures that monitor the output and validate the performance of the manufacturing processes. There is failure to thoroughly review any impenetrable discrepancy and failure of a batch or any of its components. Another major problem is lack of record keeping allowing data to be reviewed at least annually to evaluate the quality
Bob Marsh, a former detailer (product specialist and sales associate) of Kramer Pharmaceutical was fired because of failure to comply with company protocol. Marsh worked at Kramer Pharmaceutical for 12 years and was considered a hard working, well established detailer. He possessed excellent references and credentials, however Marsh was asked to resign after failing to make several changes in his behavior. Although it was a little unconventional, his methods have worked well for him for 12 years. This matter of termination would have not even been an issue, if irate customers did not complain on Bob Marsh's behalf.
Today’s business world presents numerous ethical issues. In today’s world above board/moral ethics in organizations do not often materialize intuitively. Organization must strive to provide employees with a clear understanding of the overall company vision. This will aid employees in practicing the code of ethics, policies and procedures in the workplace. Companies must be unwavering in continuously delivering the uppermost ethics of provision in which customers, applicants and employees are entitled to under fair business practices. One major core value is to uphold responsible and fair business practices.
Every organization also has a profession responsibility to conduct business honestly and ethically. Our readings reported, “Experts estimated that U.S. companies lose about $600 billion a year from unethical and criminal behavior” Kinicki and Kreitner (2009). The organization could avoid having ethical issues by meeting the
Valeant Pharmaceuticals International Inc. (referred to as Valeant hereafter) is a specialty company whose goal is to improve the lives of people in need of medical supplies. As a result, they have developed, manufactured, and marketed a range of brand name, generic, and over-the-counter products and medical devices. They also focus on developing and introducing new treatments through R&D researches and whose headquarters are in Laval, QC and Bridgewater, N.J. (Valeant Inc, n.d.-a). For the purpose of this paper, I will give an overview of the company’s history and operation, its nonmarket environment and strategy, and formulate a conclusion and recommendation based on my research.
There has been an ever increasing pressure on pharmaceutical companies with respect to proactive detection and management of safety signals or concerns related to the use of a medicinal product and grave concerns regarding public health impact. This along with strict regulatory requirements has sparked the exponential rise of the global PV market. Many high profile drug withdrawals (e.g. Vioxx i.e. rofecoxib from Merck that was recalled in 2004) in the past decade has led to various pharmaceuticals to adopt Good PV Practice guidelines in a more stringent way. These factors are expected to drive the growth of the global PV market.