Team KHDR

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Team KHDR by Mind Map: Team KHDR

1. legislations that support the FDA cares about the public health and the consumer's protection

2. Most of the time drugs are found by accident, “For example, Retrovir (zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. Twenty years later, researchers discovered the drug could treat AIDS, and Food and Drug Administration approved the drug, manufactured by GlaxoSmithKline, for that purpose in 1987.”

3. We are already informed that the FDA is an organization that provides safely edible food to our people using accurate, and scientific evidence. Since 1848, a "spark" occurred, where the Drug Importation Act was passed by Congress, requiring US Customs Service to repress the entry of adulterated drugs from overseas. Eventually, it gradually advanced, becoming the FDA. • FDA could possibly collect tax. For what will the FDA use the tax money for? • If monopolization happened in the Food and Drug Regulation industry, will we be guaranteed to trust them? • The reaction time of the FDA is slow, yes. But has there been any case of god speed recalls? • If the FDA was removed, then who will take the FDA’s place? After all it has been around for nearly a century. • How would the Neo-FDA make a difference? How would they regulate the corps that put medicine on shelves? - Who invented, and what was the purpose of warning labels? - If the FDA was abolished, how would the medicinal companies feel who were FDA approved? - Economically, would Medicinal companies benefit from the removal of the FDA? - Would we have to turn to our farmers for our food to be edible?

4. fda positives and negatives

5. Coach, Editor, and Director

5.1. Preparation

5.2. Collaboration

5.3. Clarity of Expression

5.4. Timing

5.5. Debate Format

5.6. Etiquette

6. Opening Statement

6.1. Essential Background Information

6.2. From the beginnings of civilization people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848, although the first federal biologics law, which addressed the provision of reliable smallpox vaccine to citizens, was passed in 1813.

6.3. The FDA is important because it is known for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products and medical devices.

7. Arguments

7.1. they want to constanly improve their regulations by hearing it from the people

7.2. For a long time they have changed many aspects of drugs

7.3. want to help the people effectively and safe from drugs

7.4. "A Brief History of US Medical Device Regulation." Emergo. Web. 10 Dec. 2014. <http://www.emergogroup.com/resources/history-us-medical-device-regulation>.

7.5. "Legislation." Legislation. Web. 10 Dec. 2014. <http://www.fda.gov/RegulatoryInformation/Legislation/default.htm>.

7.6. http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda/selectedenforcementactionsonunapproveddrugs/default.htm

7.7. http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htm

7.8. http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/

7.9. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213030.htm

8. Cross Examination

9. Rebuttal

9.1. The FDA goes above and beyond what most people believe they are in charge of. They regulate radiation emitting products, drugs, medical services, food, vaccines, blood, biologics, animal, veterinary, cosmetics, and tobacco products.

9.2. “Some people would hurt themselves taking the wrong drugs or neglecting various drug interactions.” (http://fee.org/freeman/detail/a-world-without-the-fda)

9.3. Without the FDA, drug companies could be handing people untested, harmful drugs without them being tested because the FDA wouldn’t be enforcing them to do testing. If it is voluntary, would you?

9.4. The FDA believes makes life easier for everyone. The FDA created Cochlear Implants to make hearing easier for the elderly and give those who have a birth defect with not being able to hear the opportunity for that.

9.5. According to the paper The US Food and Drug Administration: A Cornerstone of America’s Economic Future, currently “the export market for U.S. foods is growing; but, without adequate safety standards, that growth could be jeopardized…” without the FDA.

9.6. The FDA Food Safety Modernization Act is a law that was passed gives the FDA more money in order to fulfill their duties since the government has threatened to cut their budget. (http://www.foreffectivegov.org/node/11543)

9.7. The FDA is in charge of product control. Without product control products wouldn’t be lived up to high standards. (http://benefitof.net/benefits-of-fda/)

9.8. The FDA always informs their consumers on the product that is being given to them in multiple ways. Such as through the media. (http://benefitof.net/benefits-of-fda/ )

9.8.1. • The reason it takes so long for the FDA to go through is because they have to go through a long process to ensure the safety of the drug before it is distributed among society. First animal testing must be conducted, then an IND must be filled out in order for the FDA before they administer the drug.

10. Closing Statement

10.1. Summary of debate

10.2. Convincing explaination your side is right.

11. Roles and Planning

11.1. Read Instruction, Rubrics, and Handouts.

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

11.3. 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

11.4. Complete Google Survey Debate Team Plan

12. Instructions, Rubrics, and Handouts

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

12.2. Debate Handout Form

12.3. Concept Map Directions

12.4. Concept Map Template

13. Research and Citations

13.1. http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm409035.htm http://www.foodsafetynews.com/2014/08/federal-data-shows-increases-decreases-in-antimicrobial-trends/#.VIXuO6Eo7IU

13.2. http://www.edinformatics.com/biotechnology/fda_def.htm

14. protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. The FDA is also responsible for the safety and security of most of our nation’s food supply, all cosmetics, dietary supplements and products that give off radiation.

15. • The FDA also helps ensure that the packaging process is sanitary and goes through an orderly process. Without this people could be handed disease contaminated meat that would ruin the overall health percentage in the society. By the FDA keeping a close eye on how are meat is packaged, helps boost the economy. The FDA also monitors working conditions to ensure the meat wont be contaminated by any illnesses that could be prevented; such as rat poisoning. Working condition policies include washing your hands before handling the meat and after handling the meat. This helps prevent any disease contaminated meat being spread anywhere else. The FDA also makes sure the working place is sanitary. There shouldn’t be rats all over the place or leaking water draining onto the meat. All these gruesome things were mentioned from exerts from Upton Sinclairs, The Jungle. The FDA keeps us safe every day of our lives from harmful bacteria and toxins in our foods. What could we do without them? Yes sometimes the FDA has their faults but more than half the time we are 98% safe. People are always going to get food poisoning no matter what the FDA does. There is never going to be a 100% guarantee of a germ-free meal. But, the FDA can help reduce the chances of illnesses.

16. • When the FDA delayed the approving of a new drug that would extend people’s lives by boosting their immune systems that were on death row called Provenge. Do you wanna know why they did that? The test the doctors performed was so small that the drug could have only had a positive outcome because it was so small. Without this the drug could be given to thousands of deathly ill people and would’ve given them false hope. It wouldn’t have been fair. The FDA was protecting the people.

17. • The FDA has encouraged small business. This includes local farm industries. FDA encourages restaurants to buy from locals so it can decrease the chance of illnesses like food poisoning to a wider percentage of people.