Legal Issues

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Legal Issues.

Legal Issues


A whistleblower is an individual who informs the authorities or the public regarding who any illegal activity or alleged dishonest conduct happening in an organziation, a private company or a government department. This suspected bad conduct might be categorized in various ways: for instance, a violation of a rule, law, regulation or a direct public interest threat which may include corruption and safety/health violations (Mary, 1993). The allegations of the Whistleblowers may be made internally or externally. United States False Claims Act (revised in 1986) was one of the very first laws which safeguarded the whistleblowers in 1863 by United States government trying to fight the suppliers' fraud in the course of the Civil War. This act promises the whistleblowers a percentage of damages won by the government or the money that is recovered by the damages.

It is worth noticing whether the decision of whistle-blowing is right depending upon a great height on its results: blowing the whistle is the wrong option if the desired outcomes are not achieved and some would still insist that it was the right decision. However, there still is a propensity to assess the nature of the decision on the basis of the motivation of the whistle blower. The concept of Whistle-blowing is necessarily viewed as self-sacrifice. In one of the ways, the whistle blowers should struggle to behave like saints (Mathieu, 2007).

Pierce v. Ortho Pharmaceutical Case

Question # 1: Wrongful discharge

An employee is held to have a case of action for wrongful discharge when the discharge is different to a clear public policy authorization. The public policy sources comprise of administrative regulations, rules or decisions; legislation and judicial decisions. In such situations, an expression of public policy decisions may be contained in a professional code of ethics. However, until a particular expression of public policy is made by the employee at will, there may be no discharge on him without a reason. In this case, the dissenting judge enacted the Conscientious Employee Protection Act during the year 1986, which was as response towards the decision of the Court in Pierce. CEPA maintain a legal exclusion to the already existing general rule that an at-will employee may be terminated by the employer without or with cause.

Question 2: Procedure for obtaining FDA Approval of a new Drug

The FDA's Center for Drug Evaluation and Research (CDER) is charged with the mission to guarantee that effective and safe drugs are marketed in the country. There is no drug testing is held by CDER, though, a limited research is conducted by the Center's Office of Testing and Research regarding the safety, quality, and effectiveness of drugs. Of the five centers of FDA, CDER is the largest centre. The organziation is charged with the responsibility for both over-the-counter (OTC) or nonprescription and prescription drugs. Besides this, the responsibility for radiological devices, medical, cosmetics and food, and veterinary drugs, and biologics is undertaken by the other four centers of FDA.

A new drug application (NDA) is submitted by some ...
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