Business and Management
Submitted By thienanh
Week 2 Homework – Administrative Law Assignment
State the administrative agency which controls the regulation. Explain why this agency and your proposed regulation interest you (briefly). Will this proposed regulation affect you or the business in which you are working? If so, how? Submit a copy of the proposed regulation along with your responses to these five questions. The proposed regulation can be submitted as either a separate Word document (.doc) or Adobe file (.pdf). This means you will submit two attachments to the Week 2 Dropbox: (a) a Word document with the questions and your answers and (b) a copy of the proposed regulation you used for this assignment. (10 points)
Department of Health and Human Services – Food and Drug Administration
As an independent pharmaceutical representative currently contracted with a company who manufactures, markets and samples prescription drugs for colds, coughs and allergies this will have a significant impact on my prescription product line.
2. Describe the proposal/change. (10 points)
The proposal will no longer allow the marketing, production, distribution and or sell of unapproved FDA prescription drugs for colds, coughs and allergies.
3. Write the public comment that you would submit to this proposal. If the proposed regulation deadline has already passed, write the comment you would have submitted. Explain briefly what you wish to accomplish with your comment. (10 points)
My comment is that although these drugs have not been individually and independently approved by the FDA, they have been modeled after formulations that have been previously approved. Using the same active ingredients that have been used for symptomatic relief for decades. Furthermore In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (the Act), which required that new drugs be approved for safety. As discussed below, the active ingredients of many drugs currently on the market were first introduced, at least in some form, before 1938. Between 1938 and 1962, if a drug obtained approval, FDA considered drugs that were identical, related, or similar (IRS) to the approved drug to be covered by that approval, and allowed those IRS drugs to be marketed without independent approval. Many manufacturers also introduced drugs onto the market between 1938 and 1962 based on their own conclusion that the products were generally recognized as safe (GRAS) or based on an opinion from FDA that the products were not new drugs. (Marketed Unapproved Drugs Compliance Policy Guide, June 2006, Appendix A)
4. Provide the "deadline" by which the public comment must be made. (If the date has already passed, please provide when the deadline was). (5 points)
In this case a public comment period does not apply, due to the fact that the FDA had included the following language in the previous approved Marketed Unapproved Drugs CPG. “the Agency may, at its discretion, identify a period of time during which the Agency does not intend to initiate an enforcement action against a currently marketed unapproved drug solely on the ground that it lacks an approved application under 505 of the FD&C Act”
5. a. Once you have submitted your comment, what will you be legally entitled to do later in the promulgation process (if you should choose to do so)? (See the textbook's discussion of the Administrative Procedure Act.)
b. If the proposal passes, identify and explain the five legal theories you could use in an attempt to have (any) administrative regulation declared invalid and overturned in court.
1. Arbitrary and Capricious - requires the agency to present evidence for the proposed rule
2. Substantial Evidence Test - requires that more convincing evidence exist in support of the regulation than against it
3. Ultra Vires - a regulation that extends beyond the authority given to the agency in it enabling act
4. Sunset Law - an enabling act which congress in which congress creates an agency for limited period of time during which the agency must establish its benefits and other justification for its continuation
5. Zero Base Budgeting - forces an agency to start the year of with a budget of zero and then is required to justify all its needs for funds
c. Which of these challenges would be the best way to challenge the regulation you selected for this assignment if you wanted to have the regulation overturned and why?
Upon careful review of this regulation change, I would use the Substantial Evidence Test challenge to have this regulation overturned. Due to the fact the FDA has failed to prove that there is more convincing evidence in support of the regulation then against it.
“In light of the FDA announcement, it is important to make a distinction between these unapproved drugs and the individual components within the drugs," Dr. Thomas B. Casale (http://www.nbc29.com/story/14173259/fda-bans-unapproved-prescription-cough-cold-and-allergy-meds) the active ingredients in these prescription drugs have been used for decades. Like all medications approved by the FDA or not, there is always going to be some side effects with prescription drugs. It is important to note when considering a ban on a certain drug or classification of drugs whether or not the side effects and the risks outweigh its benefits. These specific active ingredients have been prescribed by physicians for decades to millions of patients. When taken correctly in accordance with doctor’s orders, there is no significant data that indicates that these drugs have caused more harm than good.
I believe that the FDA would not be able to prove that such data exists that would favor their regulation. Although there are some documented cases that would support the FDA’s ruling, there would not be a considerable number when compared to how long and how many patients have been treated with these particular drugs.