Bayer's record fraud. (2003). Multinational Monitor, 24(5), 6.
Cases of fraud have been increasing in recent years. This journal is a reflection of business laws. The author opens the article by saying, "everyone is expected to obey the law -- not only the letter of the law, but the spirit of the law as well,” (Multinational Monitor, 2003). This a good example of what the law and organizational ethics expect from people within our society. Fraud and ethics are major topics that have been covered in this article. The author’s main argument is that companies should adhere by the law and organizational ethics. I believe this article will better help me to understand the current FDA laws and why business ethics are important.
Falit, B. (2005). The path to cheaper and safer drugs: Revamping the pharmaceutical industry in light of GlaxoSmithKline's settlement. The Journal of Law, Medicine & Ethics, 33(1), 174-179.
In this article, the author reviews the facts and settlement agreements reflected from the GlaxoSmithKline case. In addition, the article discloses concealment of safety and efficacy information of Paroxetine HCL, also known as Paxil, and the importance of the FDA’s rating system. The article discusses the importance of food and drug regulations as well as safety measures that ought to be taken to minimize a pharmaceutical companies' ability to misinterpret or misrepresent the results of clinical trials.
This is arguably a reliable source since it gives clear information on the subject and has a long list of references. Based on this, I can say that it is not only reliable, but also an objective one. This article should provide me with a clear source to best understand the pertinent details of the GSK trials.
Greenwood, K. (2011). The ban on "off-label" pharmaceutical promotion: Constitutionally permissible prophylaxis against false or misleading commercial speech? American Journal of Law and Medicine, 37(2), 278-98.
This author believes the ban on off-label products is the best approach towards a healthy nation. According to Food and Drug agency as documented in this article, there has been misleading information about banning of off-label products. The topics that are covered include food and drug laws that protect consumers from harmful products.
The main argument is the on-going misleading information of food and drug regulations and why these laws must be enacted. The article seems quite useful and as objective as possible. The author is also clear and straight to the point. This being said, the article will allow me to consider both sides of the off-label products debate and may change or reinforce my personal opinions during my research.
McKenney, D. (2013). Off-label drug promotion and the use of disclaimers*. Texas Law Review, 92(1), 231-252.
This source provides the fullest back story on the case out of all of my research. The first part of this article explains misbranding and off-label promotion while discussing the ethical profits and costs of using this system. The rest of the article goes on to give possible solutions and provide opinions on whether this system should be allowed by the FDA. The list of supporting references is almost as long as the article itself. I believe this source will allow me to better understand why off-labeling is such a debate and determine whether or not I believe it is ethical. It will also help me in targeting GSK and save me from being too general in my paper.