Prompt: After completing the lecture and reading assignments, compose a well-written response paper to the following question: The Kefauver-Harris
Drug Amendment Act was ratified initially in 1962. Discuss the effect of the amendment and why you believe this law so severely criticized. As a
Christian 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 format
Paper Below:
Paragraph
With the passage of the amendments, FDA was no longer a helpless bystander while
unproven medicines were streaming into pharmacies and onto patients’ bedside tables,” says
Hamburg(Kef12]. The Kefauver Harris Amendment of 1962 lead to the FDH taking charge of
the reviewing of the effectiveness and safety of all new drugs, which then could be promoted
only after being approved[Lei152]. The Kefauver Harris Amendment of 1962 brought about
many different changes to the
drug review process in the United States
Some of the major changes that were brought about due to the Kefauver Harris
Amendment of 1962 was that it called for the company that is in control of the advertisement of
a drug to disclose the exact information about its side effects, and subsequently report any
serious side effects. The Kefauver Harris Amendment also prohibits the promoting of cheap
generic drugs[Dax]. According to “It gave FDA 180 days to approve a new drug application, and
required FDA approval before the drug could be marketed in the United States. It allowed FDA
to set good manufacturing practices for industry and mandated regular inspections of production
facilities. And it also transferred to FDA control of prescription drug advertising, which would
have to include accurate information about side effects[Kef12].”
The Kefauver Harris Amendment of 1962 is severely criticized due to the point that it is
said that the FDA holds too much regulatory power[Mat12). That causes alleged problems with
the approval of some drugs, which are supposed to be able to save lives. As well as concerns
about the time it takes for needed drugs to get the needed approval. Also, it’s been claimed that
the regulation process is biases toward some worthy drugs[Mar12)
As a Christian administrator, I really couldn’t come up with any Christian changes that I
would implement to The Kefauver Harris Amendment of 1962. I would suggest that you just add
your Christianity touch to the already Kefauver Harris Amendment of 1962. I would suggest that
you do as Philippians 2:4(NTV) states. “Not looking to your own interests but each of you to the
of the others.”
And as what is stated in Ecclesiastes 1:9(NIV),
“What has been will be
again what has beer
done will be done again; there is nothing new under the sun.” Which all of
those scriptures basically states, look to the interest of the ones you are trying to help, and
DeW
All 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 the
safety and effectiveness of the drugs that were being put on the market. That then could only be
promoted after being approved to be safe.
The Kefauver Harris Amendment called for the
company that is in control of the advertisement of a drug to disclose the exact information about
its side effects, and subsequently report any serious side effects. It also outlaws the promoting of
cheaD
generic drugs(Dax]. The Kefauver Harris Amendment of 1962 is severely criticized due to
the point that it is said that the FDA holds too much regulatory power (Tanner, 2012). As a
Christian administrator, I really couldn’t come up with any Christian changes that I would
implement to The Kefauver Harris Amendment of 1962. Therefore, The Kefauver Harris
Amendment of 1962 in actionality has brought about a lot of good changes to the drug market
by ensuring that the rugs being put out are sate and electiveness
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