4). The importance of an FDA drug approval is that it gives the consumer the confidence of knowing that the drug has been deemed safe for its marketed purpose. If the allegations against Pfizer are correct, Pfizer not only acted illegally, but it potentially placed its customers’ health at risk. The Whistleblower Statute, a part of the False Claims Act, allows an individual to file suit against a company for
Perhaps more so than Emotivists, Prescriptivists see ethical language as fairly meaningful. They believe that the terms used are able to create absolute rules that everyone ought to follow. It would seem that ethical language is seen by many as very meaningful, although for varying reasons. However agent centred theories such as Virtue Ethics would argue that our main focus of morality should be on becoming as virtuous as possible, rather than deciding what is meant by ethical language. Therefore it would seem that perhaps morality should be more focussed on individuals’ actions rather then defining what is meant by ‘good’ and
The reason that a company has aims and objectives is so that they have goals to achieve because it is important that all businesses have a plan to follow. The purpose of a mission statement is to outline a businesses main aims and clearly identify the purpose of the organisation to all of it's stakeholders. All of the above methods (missions, aims and objectives) are all forms of strategic planning. The strategic planning process of an organisation is the process through which all the major plans for the company are created. The aims of a company are strategic because they are there as steps to be the best that they can be and are ways in which the company can achieve what they set out to do.
I have also considered legal and moral responsibilities to our customers. We pride ourselves on the business ability to exceed highest quality standards to our customers. This has built an environment of trust. Our reputation and image should be a high priority in action that we take. After careful consideration of possible options three viable options are highlighted that I feel would maintain the trust and our reputation with our customers.
Defending Utilitarianism: A Practical Train of Thought Utilitarianism is a philosophy that was outlined by John Stuart Mill in the nineteenth century in his book Utilitarianism. The central concept of which was that “actions are right in proportion as they tend to promote happiness, wrong as they tend to produce the reverse of happiness”. Actions are looked at in terms of a net value which is either pleasure bringing or pain bringing, subsequently good or bad. Utilitarianism serves as a moral code in the sense that when practiced, one looks at the consequences of their actions. Consequences not only include their impact on the individual, but on others as well.
Explain how Bentham’s version of Utilitarianism may be used to decide on the right course of action. Utilitarianism is a teleological theory of ethics. It is a method that looks at the consequences of an action to deice whether it is right or wrong; this also makes it a consequentialist theory. In the eighteenth century Hutchenson first used the phrase ‘the greatest good for the greatest number’ which he used to describe the political systems. Jeremy Bentham (1748-1832) then decided to develop his idea of Utilitarianism from this quote and apply it to all areas of social activity.
Explain: Causality or relatedness assessment determines whether there is a “reasonable possibility” that the product is causally related to the adverse event. (1) In practice, FDA (21CFR32) is using the term “suspected adverse drug reaction” (SADR), to emphasize the suspicion that the drug is a possible cause of the adverse event. Suspected Adverse Drug reaction (SADR) implies a lesser degree of certainty about causality than the term Adverse Reaction. (2) The European Union ENTR/ CT3 clarified that all adverse events assessed by the investigator or the sponsor and imply having a reasonable evidence for a causal relationship to an investigational medicinal product qualify as adverse reactions. (2) In practice, many companies have two types
ALL WK 1, DQ’s: WK 1, DQ 1: What is a business’s obligation to build an ethical culture and balance its desire for profit with ethical responsibilities to employees, customers, society, and the environment? Ethics is different from one person to the next, so it is imperative that business clearly define the norm for staff members and management. The decisions organizations make influence more than business partners, affiliates, culture, and others. It is important for organizations center of attention on maximizing shareholder revenue. Therefore, maximizing profit without causing destruction to the business culture can be a balancing act for most organizations.
Pleasing the personnel is one of the principal goals of any business to survive and develop in this huge competitive trade. This indeed is a vast trial that is to be reached by the business. For the personnel to be pleased it
Off labeling can mean that the drug is used for a different condition than intended for, given in a different way, or given a different dosage than what is written on the drug label. This action is lawful throughout the United States and in several other countries. A rare exception to this legality would be a highly addictive narcotic such as morphine. These drugs cannot be lawfully prescribed unless done by officially approved purposes (American Cancer Society). Once a company’s drug has passed this part of the process by showing that the drug is helpful and safe (Consumer Reports Best Buy Drugs 1), they have to create a drug label.