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Prompt: After completing the lecture and reading assignments, compose a well-written response paper to the following question: The Kefauver-HarrisDrug Amendment Act was ratified initially in 1962. Discuss the effect of the amendment and why you believe this law so severely criticized. As aChristian administrator, discuss your ideas for implementation of this law.• Requirements: Do not use the question in the response. Papers must include a substantive elaboration on the topic as well as support from scripture.750-1000 words, APA formatPaper Below:ParagraphWith the passage of the amendments, FDA was no longer a helpless bystander whileunproven medicines were streaming into pharmacies and onto patients’ bedside tables,” saysHamburg(Kef12]. The Kefauver Harris Amendment of 1962 lead to the FDH taking charge ofthe reviewing of the effectiveness and safety of all new drugs, which then could be promotedonly after being approved[Lei152]. The Kefauver Harris Amendment of 1962 brought aboutmany different changes to thedrug review process in the United StatesSome of the major changes that were brought about due to the Kefauver HarrisAmendment of 1962 was that it called for the company that is in control of the advertisement ofa drug to disclose the exact information about its side effects, and subsequently report anyserious side effects. The Kefauver Harris Amendment also prohibits the promoting of cheapgeneric drugs[Dax]. According to “It gave FDA 180 days to approve a new drug application, andrequired FDA approval before the drug could be marketed in the United States. It allowed FDAto set good manufacturing practices for industry and mandated regular inspections of productionfacilities. And it also transferred to FDA control of prescription drug advertising, which wouldhave to include accurate information about side effects[Kef12].”The Kefauver Harris Amendment of 1962 is severely criticized due to the point that it issaid that the FDA holds too much regulatory power[Mat12). That causes alleged problems withthe approval of some drugs, which are supposed to be able to save lives. As well as concernsabout the time it takes for needed drugs to get the needed approval. Also, it’s been claimed thatthe regulation process is biases toward some worthy drugs[Mar12)As a Christian administrator, I really couldn’t come up with any Christian changes that Iwould implement to The Kefauver Harris Amendment of 1962. I would suggest that you just addyour Christianity touch to the already Kefauver Harris Amendment of 1962. I would suggest thatyou do as Philippians 2:4(NTV) states. “Not looking to your own interests but each of you to theof the others.”And as what is stated in Ecclesiastes 1:9(NIV),“What has been will beagain what has beerdone will be done again; there is nothing new under the sun.” Which all ofthose scriptures basically states, look to the interest of the ones you are trying to help, andDeWAll has been done before, and be mindful of your purposellssox].The kefauver harris Amendment of 1962 was a law that came about to help ensure thesafety and effectiveness of the drugs that were being put on the market. That then could only bepromoted after being approved to be safe.The Kefauver Harris Amendment called for thecompany that is in control of the advertisement of a drug to disclose the exact information aboutits side effects, and subsequently report any serious side effects. It also outlaws the promoting ofcheaDgeneric drugs(Dax]. The Kefauver Harris Amendment of 1962 is severely criticized due tothe point that it is said that the FDA holds too much regulatory power (Tanner, 2012). As aChristian administrator, I really couldn’t come up with any Christian changes that I wouldimplement to The Kefauver Harris Amendment of 1962. Therefore, The Kefauver HarrisAmendment of 1962 in actionality has brought about a lot of good changes to the drug marketby ensuring that the rugs being put out are sate and electiveness
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