Week – 2 Homework GM 520

1. State the administrative agency which controls the regulation. Explain why this agency and your proposed regulation interests 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: (1) a Word doc with the questions and your answers and (2) a copy of the proposed regulation you used for this assignment. (10 points)

Ans . Food and Drug Administration (FDA) is the agency which control the regulation. FDA is an agency of Department of Health and Human Services. FDA is responsible for the regulation and inspection of food industry and drug industry including prescription drugs, OTC drugs, cosmetics, veterinary drugs, vaccines etc. By which they are responsible to protect and promote health society.

It will not affect me or the place where I am working but my background in Pharmaceutical production and management brings interest in this regulation. Because when pharmaceuticals are committed to provide quality services to the community at the same time they have to follow the rules and regulations which cost the business a good amount of money to introduce a new regulation. Here in this case the gluten free drug manufacturing cost them a good amount of money to develop a new formula which has to be as effective as the previous one but without Gluten. Second point is their investment in the raw material, labels, containers etc. cost them money and if the formula has changed then they lose the money on the investment. So, it is a question to the pharmaceuticals because one side they are committed to the society but on the other side they are responsible for the stockholders.

2. Describe the proposal/change.

The Agency is evaluating various approaches for helping patients with celiac disease avoid the presence of gluten in drug products. Agency is trying to collect the information on the number of drugs manufactured using the gluten or similar derivatives and any alternative can be use for that.

3. Write the public comment which 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) I am agree with the FDA in approach to identify and possible elimination of the Gluten or similar derivatives from the drug products in beneficial to the patients with Celiac disease. According to the information provided by the FDA, The prevalence of celiac disease in the United States is estimated to range from about 0.4 percent to about 1 percent of the population which means at least one person out of hundred suffer from celiac disease. Celiac is a immune mediated chronic inflammatory disease. Sometimes failure to avoid the consumption of the Gluten may lead to llife threatening situation for the individual. All these data provided gives us a clear picture of the avoidance of the patients with Celiac disease. Over time consumption of the medication with gluten for other disease by Celiac patient put their life on danger to cure other diseases. Reason for the patients to take the medications with gluten is no alternative medication which does not have gluten. Being responsible healthcare provider pharmaceutical companies has to do, i) Provide the information with the number of the formula contain gluten and possibility of the alternatives. ii) Research on the alternative for the gluten without changing the formula. iii) Put the indication on the label about Gluten used in the formula or “Gluten free” formula.

Pharmaceutical company will lose some amount of money in present time but it is beneficial in long term because if in future the ratio of the Celiac disease increases than they do not have to worry about developing the formula or changing the labels. Being responsible for the protect and promote Healthy society, FDA took this step to do more to provide assurance to individuals who have Celiac disease that drug product will not harm them. 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)
Dead line is March 20th 2012.

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.)
Once I submit my comment and the deadline of the comments is expired. The documents published in federal register for additional comments. Those who comment during the proposal can challenge the rule in court but for that a person has to post the comment during the proposal stage. An administrative rule can be challenge on several different grounds.
The first ground on which to challenge an agency rule is that it is arbitrary, capricious, an abuse of discretion, or in violation of some other law. This standard is generally applied to informal rulemaking and simply requires the agency to show evidence to support the proposed rule. Without such evidence, the rule can be held to be arbitrary and capricious. If the agency decide to make changes in rule than once they make changes than they have to follow the same process again from the beginning with the proposal stage.
b. If the proposal passes, identify and explain the five legal theories you could use in an attempt to have the regulation declared invalid and overturned in court or support in court.
1) The first ground on which to challenge an agency rule is that it is arbitrary, capricious, an abuse of discretion, or in violation of some other law. This standard is generally applied to informal rulemaking and simply requires the agency to show evidence to support the proposed rule. Without such evidence, the rule can be held to be arbitrary and capricious. If the agency decide to make changes in rule than once they make changes than they have to follow the same process again from the beginning with the proposal stage.
2) A second theory for challenging an agency’s regulation is that the regulation is unsupported by substantial evidence. This substantial evidence test is applied in the review of formal and hybrid rulemaking. Where the arbitrary and capricious standard simply requires some proof or basis for the regulation, substantial evidence requires that more convincing evidence exist in support of the regulation than against it.
3) A third ground on which to challenge an agency’s regulation involves the rule that a regulation can be set aside if the agency did not comply with the APA requirements of notice, publication, and public comment or input. The procedures for rulemaking must be followed in order for the regulatory process and resulting rules to be valid. An agency that seeks public comment for the purposes of drafting legislation cannot then turn the legislation into rules after the comment period. The notice must specify that promulgated rules will be the result of the proceedings.
4) Another basis for challenging a regulation is that the regulation is unconstitutional. Many challenges based on constitutional grounds deal with regulations that give an agency authority to search records or that impose discriminatory requirements for licensing professionals. For example, a requirement of a minimum residency period before allowing an applicant to become licensed in a particular profession has been challenged successfully.
5) Another theory for challenging a regulation in court is ultra vires, a Latin term meaning “beyond its powers.” An ultra vires regulation is one that goes beyond the authority given to the agency in its enabling act. Although most agencies stay clearly within their authority, if an agency tries to change the substance and purpose of the enabling act through regulation, the regulations would be ultra vires.
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?
I think the best supportive theory in this case is substantial evidence theory because the agency has provided enough number of evidence supporting the severity of the Celiac disease and no cautious activity provided by pharmaceutical companies which may lead to the life threatening situation for patients. Also, their request for the documents in usage, alternatives of Gluten shows their responsibilities towards drug provider because they want to make a fair solution for both the patients and drug manufacturer.