Pharmaceutical and Medical Device Law: COURSE OUTLINE

Course Paper Outline: One-page outline of your paper including main ideas – DUE 21-NOV-2020

Submit a course paper to discuss and evaluate: The regulation of tobacco products, including advertising and promotion

How to approach the paper include:  

1.Chose a specific section of the FDCA (covered in the course- I will provide this) and applying it to the topic above

2.Identify a Warning letter from the FDA website and explain how the manufacturer violated the FDCA and what steps need be taken to prevent the further violation or what other enforcement actions may the FDA bring in this case. 

The requirements for the paper are as follows: 

Use a minimum of 3 cases discussed in the class ( I can also provide this or we can current cases being reviewed by the courts and describe how a specific decision applies to your chosen topic. The course paper is to be a minimum of 10 pages in length double-spaced (not including citations), font size 12, 1 inch margins. Organization of the Paper: 

A. Introduction – State your topic and the purpose of your paper clearly –  What is the main reason you are writing the paper? Explain briefly the major points you plan to cover in your paper and why readers should be interested in your topic. I have already started with and actually submitted the introduction below


The chosen topic of my course paper is “The regulation of tobacco products, including advertising and promotion” 

Tobacco and Tobacco products are not considered therapeutic agents, yet, the Centers for Disease Control and Prevention estimates that over 34 million Americans use Tobacco products. The CDC also mentions that Tobacco manufacturing companies spent over $9 billion dollars in advertisement in 2018 alone (“Tobacco industry marketing,” 2020). These are astronomical numbers for a product that raise potential health concerns. 

I have thus chosen this topic to discuss the unique public health standards used by the FDA to evaluate Tobacco Products. My paper will also examine effective regulations, advertising, promotion, and statutes that impact the measures of the FDA’s evaluation of these Products.”

b. Body (Facts, Analysis, and Discussion) – Present the findings about your topic and supporting arguments. Cases would be included in this section.

c. Conclusion – Restate the reason you are writing the paper. Summarize your findings and arguments. Explain why you have come to this particular conclusion