Reducing the regulation of the FDA

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Use this concept map as a template to create a plan for your debate. This is a basic suggestion for format and roles. Your group's concept map should be personalized, explore your issue more fully, and showcase your group's research and collaboration.

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Reducing the regulation of the FDA by Mind Map: Reducing the regulation of the FDA

1. Coach, Editor, and Director

1.1. Preparation

1.2. Collaboration

1.3. Clarity of Expression

1.4. Timing

1.5. Debate Format

1.6. Etiquette

2. Opening Statement

2.1. Define The Issue: The FDA has become too powerful and is over-regulating the people and businesses of the United States

2.2. Why is it important?: This is important because it is hurting the economy and giving too much power to the federal government to control the daily lives of the American people

2.3. Historical Discussion: The Food and Drug Administration is the oldest comprehensive consumer protection agency in the US government. It can be traced back to the mid 1800's but it was never recognized by it's name until 1906 when the Pure Food and Drugs Act was passed.

2.4. Essential Background Information: According to the FDA"s official website the main goal is to protect the public safety and health.

3. Arguments

3.1. Major Points (3-4) with cited evidence

3.2. 1.

3.2.1. Hundreds of millions of dollars needed for approval of any new drugs, along with the extremely lengthy process involved. Since the mid 1900's the total time for drug development has more than doubled and is now more than 15 years. Which is because the FDA has over used their authority to expand their power and over regulate business.

3.2.2. The FDA is the main reason that drugs are expensive. Whenever a drug company attempts to approve a new drug, the process is irrational and unreliable, the process costs the drug company millions of dollars and in turn, drives up the overall price of the drug itself.

3.2.3. 30 years ago, drug companies only paid $138 million to bring a drug to the market and they now spend around $900 million to do the same thing

3.3. 2.

3.3.1. There is a revolving door between the FDA and the biggest pharmaceutical companies. Since the FDA has the power of the law and the power to regulate businesses. They are looked at as a symbol of power to drug company lobbyists. Which causes regulations that support and protect the big drug companies and affect the consumers in a negative way. One example of this is when the FDA promoted drugs like Celebrex for people who suffered from arthritis. The FDA decided to promote dangerous prescription drugs like Celebrex instead of cheaper and more effective drugs that were proven to be effective.

3.4. 3. The FDA doesn't allow patients that have a terminal disease to experiment with drugs that haven't been approved by the FDA and could possibly help cure the disease. Many people in various states have been testifying for the Right To Try laws. One example is in Missouri where a family is testifying for these laws to be passed because their daughter has a terminal colon cancer and is going to die since there is not any type of cure to her illness. Why would the FDA allow you to smoke cigarettes as much as you want but then not allow you access to medications that could make you better. The FDA has too much power and too many regulations in place to actually help the American citizens.

3.5. 3.

3.5.1. This is a democracy not a dictatorship, and the FDA thinks otherwise. The FDA is using their power to over regulate the American people. Should the FDA really control everything you eat. In the past few years the FDA has put cheerios under their authority because the brand has advertised that it reduces cholesterol which makes it a drug. The sole purpose of cheerios is not just to lower cholesterol, which is what the FDA stated. The FDA wants too much power and this is not a dictatorship. This also goes along with the corruption involved in the FDA because it shows how they want to help certain companies and/or people, which is showed here. Lets say that you are somebody in the doctors' office and have slightly high cholesterol and your doctor tells you that you need to lower it. Then you would much rather eat a food like cheerios than pay for medication that would be prescribed to you. But the FDA wants you to pay for this medication rather than fix your daily diet. This shows the revolving door relationship between drug companies and the FDA.

3.6. manhattaninstitute source

3.7. Abusive Regulations:

3.7.1. A proposed rule by the U.S. Food and Drug Administration would drastically increase costs for American onion farmers and consumers, without any improvement in public safety. http://economics21.org/commentary/consumers-may-onions-fda-doesnt

3.7.2. Testifying before the House Energy and Commerce Subcommittee on Health today, Alan Mertz, President of the American Clinical Laboratory Association (ACLA), expressed concern to lawmakers that additional, duplicative regulation imposed by the Food and Drug Administration (FDA) on laboratory-developed tests (LDTs) would cause a harmful ripple effect throughout the laboratory industry that could hamper diagnostic discoveries and preclude patients from timely access to life saving treatments. - See more at: http://www.acla.com/acla-president-testifies-in-opposition-to-fda-intent-to-regulate-ldts-questions-statutory-authority-cautions-against-duplicative-regulation-that-could-stifle-innovation-and-compromise-pati/#sthash.tIfdAFb7.dpu.

4. Cross Examination

4.1. Predict opposition point

4.2. 1. The FDA keeps the quality of goods consumers use like drugs and food up to a high standard to protect them and regulations are proven to protect consumers

4.3. 2. If regulations are cut then the safety and health of the people is at risk when eating food and taking drugs.

4.4. FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

5. Rebuttal

5.1. Predict other side's arguments

5.1.1. They will begin to say how it has helped keep people from becoming less sick from food and drugs and how it is important for regulations for them should be set into place.

5.2. Defenses and Offenses

5.2.1. In defense to that, we will begin to say how much time and money is wasted into developing just one drug and how the effects of those two problems can affect the population of the American people.

5.2.2. As an agency that protects the American people it should be perfect right? Wrong, it is far less from perfect which is why it is gathering much flak about how it works.

5.2.3. Found an article where it uses cheese against the FDA and its over regulations, will talk about it tomorrow, Cole.

5.3. Cole find some regulations and requirements of companies that could be cut and would not affect the health and well being of the american people because they will argue that cutting regulations would harm the health and safety of us

6. Closing Statement

6.1. Summary of debate

6.2. Convincing explaination your side is right.

6.2.1. The FDA has become too powerful for the good of the American people and business. The FDA has too many regulations in place which severely hurts business by making them spend more money and time to pass these requirements. The FDA is also corrupt, because of the amount of power they have, they are seen as an important asset to Drug Companies, if they can be influenced. Which is why these companies have bought their way onto the administration of the FDA. To get legislation passed that would help their drug company. The main purpose of the FDA is to safeguard the health and well being of the American people. But many people with terminal illnesses cant try medication that could save their lives and this is because of the FDA and their over regulation. The FDA needs to cut down on regulation to help business thrive, allow citizens to use medicine that could save their life from an otherwise terminal illness, and power needs to be taken away from the FDA so there is less corruption in the federal government..

6.2.1.1. sounds good to me. From, Cody

7. Roles and Planning

7.1. Read Instruction, Rubrics, and Handouts.

7.2. Decide on roles and develop a plan for each day until the debate.

7.3. Create a google drive for the team, and create a mind map to send to Mr. Crissman. http://www.mindmeister.com/355093877/team-and-issue

7.4. Complete Google Survey Debate Team Plan

8. Instructions, Rubrics, and Handouts

8.1. http://www.mrcrissman.com/unit-four.html

8.2. Debate Handout Form

8.3. Concept Map Directions

8.4. Concept Map Template

9. Research and Citations

9.1. Submit citiations:

9.2. "History." History. Web. 7 Dec. 2014. <http://www.fda.gov/AboutFDA/WhatWeDo/History/

9.3. "Flaws in the FDA's Food Labeling Laws." Flaws in the FDA's Food Labeling Laws. 27 May 2014. Web. 8 Dec. 2014. <http://www.ncpa.org/sub/dpd/index.php?Article_ID=24460>.

9.4. "Total Corruption: Drug Companies Bought Their Way onto FDA Advisory Panels." NaturalNews. Web. 8 Dec. 2014. <http://www.naturalnews.com/042562_total_corruption_drug_companies_FDA_advisory_panels.html

9.5. Farahat, Cyntihia. "Abolish the FDA." Cynthia Farahat. 7 Feb. 2014. Web. 7 Dec. 2014. <http://cynthiafarahat.com/2014/02/07/abolish-fda/

9.6. "The FDA Kills by Bill Sardi." The FDA Kills by Bill Sardi. 22 Nov. 2005. Web. 8 Dec. 2014. <http://archive.lewrockwell.com/sardi/sardi46.html

9.7. "Flaws in the FDA's Food Labeling Laws." Flaws in the FDA's Food Labeling Laws. 27 May 2014. Web. 8 Dec. 2014. <http://www.ncpa.org/sub/dpd/index.php?Article_ID=24460>.

9.8. "Article | Wanted: Leadership at the FDA." Article | Wanted: Leadership at the FDA. Web. 8 Dec. 2014. <http://www.manhattan-institute.org/html/miarticle.htm?id=3137#.VIX4uqEo7IU>.

9.9. "The Illusions of “right to Try” Laws « Science-Based Medicine." Science Based Medicine. Web. 8 Dec. 2014. <http://www.sciencebasedmedicine.org/the-illusions-of-right-to-try-laws/

9.10. "Does the FDA Cause More Harm than Good?" Outside the Beltway. Web. 8 Dec. 2014. <http://www.outsidethebeltway.com/does_the_fda_cause_more_harm_than_good/>.

9.11. "Total Corruption: Drug Companies Bought Their Way onto FDA Advisory Panels." NaturalNews. Web. 8 Dec. 2014. <http://www.naturalnews.com/042562_total_corruption_drug_companies_fda_advisory_panels

9.12. Dooren, Jennifer. "Cheerios' Health Claims Break Rules." The Wall Street Journal. 13 May 2009. Web. 8 Dec. 2014. <http://www.wsj.com/news/articles/SB124216077825612187?mg=reno64-wsj&url=http://online.wsj.com/article/SB124216077825612187.html

9.13. "About FDA." What We Do. FDA, 5 Aug. 2014. Web. 8 Dec. 2014. <http://www.fda.gov/aboutfda/whatwedo/

10. Notes for others

10.1. Make sure that our speeches are written by tomorrow so we can practice and prepare as a group.