StudentShare
Contact Us
Sign In / Sign Up for FREE
Search
Go to advanced search...
Free

Kefauver-Harris Amendment - Essay Example

Comments (0) Cite this document
Summary
A medicinal catastrophe took place in Europe in the 1950s that produced legislation that would everlastingly amend the practice of drug in the United States. The tranquilizer had been advised to European females to assuage queasiness in the earliest trimester of pregnancy…
Download full paperFile format: .doc, available for editing
GRAB THE BEST PAPER98.9% of users find it useful
Kefauver-Harris Amendment
Read TextPreview

Extract of sample "Kefauver-Harris Amendment"

[Supervisor's Kefauver-Harris Amendment A medicinal catastrophe took place in Europe in the 1950s that produced legislation that would everlastingly amend the practice of drug in the United States. The tranquilizer had been advised to European females to assuage queasiness in the earliest trimester of pregnancy. While the sedative was looking out for government authorization in America, general practitioners revealed that Thalidomide ensued in stern birth deficiencies or caused severe bodily malformations, usually missing or distorted limbs in the exposed fetuses (Abraham &Davis, pp. 127-128). The communal protest caused by the Thalidomide calamity near the beginning of 1960s hastily directed to the road of new set of laws and an unusual sentiment regarding untried drugs. In an attempt to stop happening one more analogous tragedy at the rear of the Thalidomide mishap, the U.S. Parliament, in 1962, passed the Kefauver-Harris Drug Amendment, ordering austere controls on drug checking, promotion and selling. The edict asserted for the first time that hottest drugs must be made known to be helpful before being advertised. In addition, it proposed stringent regulations for sound engineering practices, the intention being to augment quality control in the manufacturing route. The new codes would step up to transform not only the approach Americans participated in drug experiments but also their anticipations for the safety of drugs approved by the U.S. Food and Drug Administration.
Kefauver-Harris Drug Amendment conceded collectively by the Congress to strengthened control over recommended and unproven drugs and to make certain greater drug protection. It was acknowledged that no drug is actually harmless unless it is also effectual. Before publicizing a drug, its manufacturers now had to demonstrate to FDA not just safety, but also provide considerable verification of effectiveness for the product's future utilization -- a milestone proceed in medical record. That verification had to encompass acceptable and well-controlled studies, a radical requirement. Also vitally, the 1962 amendments required that the FDA expressly accept the marketing request before the remedy could be exposed, another imperative adaptation. The Kefauver-Harris Drug Amendments also requested the Secretary to place statutes of inquiry of new drugs, containing a requirement for the notified permission of study subjects (Tabarrok, pp. 25-27).
At the start of the 20th century, there were no centralized policies to defend the public from risky drugs. It was an intimidating marketplace packed with items such as William Radam's germ executioner and Benjamin Bye's relaxing clement oils to treat cancer. Brands resembling these were, at smallest, ineffective remedies that picked the pouch of the consumer, but they could also be downright detrimental. These days, the drug evaluation process in the U.S. is accepted internationally as the gold worth. Drugs must go through a detailed assessment of safety, excellence, and effectiveness before they can be put on the market (Meadows, 2006). I suppose, the FDA's prime contribution to health has been by its advancement in evidence-based medicine. Previous to the 1962 modifications to the Federal Food, Drug, and Cosmetic Act, proscribed tryouts were still widening, and numerous sold drugs were futile for their labeled purposes. Now, the standard for testimony is the well-controlled study, and the FDA's execution of the 1962 amendments succored significantly to that.
Works Cited
Abraham, J. &Davis, C. (2006), "Testing Times: The Emergence of the Practolol Disaster and its Challenge to British Drug Regulation in the Modern Period", Social History of Medicine, Volume 19,Number 1, pp. 127-129.
Meadows M. (2006), "Promoting safe and effective drugs for 100 years", FDA Consumer Magazine Jan-Feb 2006, Vol. 40 No. 1.
Tabarrok, A. (2000), "Assessing the FDA via the Anomaly of Off-Label Drug Prescribing", The Independent Review 5, pp. 25-27. Read More
Cite this document
  • APA
  • MLA
  • CHICAGO
(“Kefauver-Harris Amendment Essay Example | Topics and Well Written Essays - 500 words”, n.d.)
Kefauver-Harris Amendment Essay Example | Topics and Well Written Essays - 500 words. Retrieved from https://studentshare.org/miscellaneous/1530012-kefauver-harris-amendment
(Kefauver-Harris Amendment Essay Example | Topics and Well Written Essays - 500 Words)
Kefauver-Harris Amendment Essay Example | Topics and Well Written Essays - 500 Words. https://studentshare.org/miscellaneous/1530012-kefauver-harris-amendment.
“Kefauver-Harris Amendment Essay Example | Topics and Well Written Essays - 500 Words”, n.d. https://studentshare.org/miscellaneous/1530012-kefauver-harris-amendment.
  • Cited: 0 times
Comments (0)
Click to create a comment or rate a document

CHECK THESE SAMPLES OF Kefauver-Harris Amendment

Fourth Amendment

...? Fourth Amendment The two basic clauses of the Fourth Amendment of the United s constitution provide that The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated 2. No warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized. (Levy 1995, p. 162) The fourth amendment was adopted in response to the tendencies of police officers to abuse their search and seizure responsibilities during the colonial period. The enactment of the fourth amendment guarantees to every citizen “the security of privacy against arbitrary intrusion...
4 Pages(1000 words)Research Paper

Sixth Amendment

...? 29th October The exposure to torture and detention of Jose Padilla is nothing short of human rights violation, considering practice and administration of justice in the United States taking into account the sixth amendment of the constitution of the United States of America which advocates for fundamental human rights which they violated in the case of Jose Padilla. Jose Padilla an American citizen born in Brooklyn New York, arrested in connection with the September 11th attack, and accused of collaboration with Al Qaeda and Taliban militias. upon His arrest, they confined Padilla for more than three years without trial on any criminal or civil charges. A ruling in a federal court backed the president's powers to confine an American...
3 Pages(750 words)Essay

Amendment rights

...Running head: EXCEPTIONS TO THE SEARCH WARRANT REQUIREMENT IN AMENDMENT RIGHTS Discussion Board 5 Discussion Board 5Unreasonable searches and seizures are guarded by the United States Constitution under the fourth amendment. This came about due to the controversial writs of assistance during American Revolution. The amendment IV is has two distinct parts whereby: The first part usually safeguards people against unreasonable searches and seizures. There had been numerous ways of remedying unreasonable searches in the ancient times unlike in the modern jurisprudence that has facilitated respect of the amendment by the police officers. The second part usually concerns the proper issue of warrants whereby it states that there should...
4 Pages(1000 words)Essay

American Government: Synopsis

...Harris Kamran Government and Politics 31 January 2008 Amendment One: Synopsis America has always been, and seen as, a land of liberty, opportunities, rights, and democracy. Freedom, a world that has come to be synonymous with the American nation, is perhaps the most valued clause upheld by authorities all over the nation, be it the Congress or the Court. The founding fathers fought for this value, their speeches being ablaze with hopeful words of liberty and equality. The Declaration of Independence, perhaps the document with the greatest import in constitutional matters, in its opening paragraphs, bolsters people as being "created equally" and having...
2 Pages(500 words)Essay

5th Amendment

...Fifth Amendment The exclusionary rule is a fifth Amendment’s product that s that no object can be used as evidence in a court of law, if obtained illegally or without a search warrant (David W Neubauer. 2006). The 1921, US Supreme court case of Gouled vs. United States, greatly contributed to the rule as it held that although the Government could seize contraband, it could not seize property to simply use it as evidence. Therefore, police are not supposed to conduct warrantless searches, since such evidence will not be held admissible, unless when something is in plain view, at an airport, during an arrest as well as when there is no time to obtain a warrant. The rule could also be taken as to follow the Fifth Amendment’s self...
2 Pages(500 words)Essay

Pompeii by Robert Harris

...Robert Harris’s novel Pompeii spans four days in the history of this Roman town. The two days prior to the eruption and the two days of eruptive violence comprise the entire span of the novel. In these four short days, the young engineer Marcus Attilius will repair an aqueduct, navigate the treacherous halls of Roman politics, solve a mystery, sail with Pliny and fall in love; all while surviving a volcanic eruption 100,000 times more powerful than the atomic bomb that was detonated over Hiroshima (Harris). Although the plot moves briskly through Pompeii, one of the real drivers of the story is the science behind the tale. The science in the book Pompeii is used by the author as foreshadowing for the events to come in each chapter...
8 Pages(2000 words)Assignment

Sixth Amendment

...Sixth Amendment Sixth Amendment The sixth amendment ensures that a person has the right to fair trial within the shortest time possible. In the pre-trial process, the accused appears before a judge in less than 24 hours. The judiciary then cross-examines the situation to set the date for the case. The government initiates the process by filing a case against a person. Thereafter, the court summons the person for a hearing. According to Smith (2008), the person has the right to defend himself from accusation before trial. At the courts, the person comes face to face with his accuser. After trail, the jury makes the verdict upon which the guilty persons have the right to appeal according to the sixth amendment. Following a verdict...
1 Pages(250 words)Essay

Amendment Impact

... of affiliation Amendments that impact the issues of Criminal identification Criminal identification process used by the police to identify perpetrators of crime has faced various proposed amendments. When crimes are committed, law enforcements will always ask the victims to identify the criminal. Normally they use various identification methods. Such include show up, line up and photo array among others. Show up method is an identification procedure where the suspect is singly presented to the crime victim (Raskin, 2009, p.75). Based on the identification results, whether positive or negative, the prosecution will take action. However, research has revealed that reliability on eyewitness identification is not effective and can easily lead...
4 Pages(1000 words)Assignment

Rewriting by Joseph Harris Assignment

... Rewriting by Joseph Harris Assignment The project of the is to outline the importance of self learning through the use of the real life experiences of the character in the article. The setting of the article is based in a prison where the character teaches himself from scratch to read and write. He first had to learn the language so as to understand the content of the books he was reading and after a short while he is good to go. He reads inspirational books on the liberation of the black man. It is from this information that he empowers himself and becomes one of the most influential people in the fight of the American History. The aim of the article is to enlighten the reader about the importance of reading and writing in general...
1 Pages(250 words)Assignment

Ford-Harris Matrix

...Ford-Harris Matrix Ford-Harris Matrix Remember Understand Apply Analyze Evaluate Create Contributions Students are taught and know facts about heroes, holidays and discrete cultural elements. students show an understanding of information about heroes, holidays, etc. Students are asked to and can apply information learned on heroes, holidays, etc. Students are taught and can analyze(e.g., compare and contrast) information on heroes, holidays, etc. Students are taught to and can evaluate facts and information based on heroes, holidays, etc. Students are required to and can create a new product from the information on heroes, holidays, etc. Additive Students are taught and know the concepts, themes and perspectives of cultural...
2 Pages(500 words)Coursework

The Most Instrumental Amendment in the Bill of Rights

... The First Amendment, First for a Reason The First Amendment to the Constitution is the most recognized and recited of the Bill of Rights within both political and social realms because it is the most essential in preserving the uniquely American freedom the Founding Fathers envisioned. The First Amendment effectively guarantees free speech, freedom of the press and religion. Freedom of the press is an extension to the freedom of speech concept. A free press is essential to the idea of democracy and has been accurately described as the ‘Fourth Estate’ of government. As the three branches of government act to check and balance each other, the press watches over them all. The freedom of religion has been interpreted by many...
6 Pages(1500 words)Term Paper

Defamation and the First Amendment

... Defamation and the First Amendment ABSTRACT This research explains the different types of defamation, as well as what defamation actually is. Additionally, a description of what peoples’ free speech rights afforded by the First Amendment, as well as the bounds of this free speech, will be discussed. Finally, an explanation will be given as to what happens in defamation suits, including specific cases as sub-topics, as well as suggested areas of further research. Defamation is a serious offense, punishable by having to either issue an apology, pay a fine, or both.1 Speaking negatively about someone can undoubtedly cause harm to that person’s character. However, what is to be said...
8 Pages(2000 words)Term Paper

The Fourth Amendment of the United States Constitution

...The Fourth Amendment of the United s Constitution Introduction The fourth amendment of the United s Constitution s that “[t]he right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched and the persons or things to be seized”. This provision in the constitution seeks to ensure personal security from unlawful searches and seizures. It guarantees that no searches and seizures shall issue except upon probable cause as properly ascertained after oath and affirmation. The carrying out of warrants should also be done...
13 Pages(3250 words)Research Paper

Amendment to Irish Constitution Granting More Rights to Children

...Amendment To Irish Constitution – Granting More Rights To Children – An Analysis Introduction Irish Constitution was drafted as early as in 1937 and children till they attain the age of seventeen, they are under the control and care of their parents. Today, society is of the view that children do have privileges and they should be allowed to exercise their individual decision when they feel necessary. The Irish constitution through its Article 40 guarantees that Irish children have imprescriptible and irrefutable rights, which safeguard their individual privileges. However, the Irish Government having considered in the background of the “undeniable right and responsibility of parents” mentioned in Article 42.1, it has come to a conclusion...
8 Pages(2000 words)Case Study

Amendment and Affirmitave Action

... Introduction Affirmative Action developed when the need for civil rights became a main issue for minority races. From the unfair laws, many began to focus on the concept of initiating new regulations to ensure that fair opportunity was provided in institutional arenas, such as educational programs and among the workforce. The 14th amendment was the main outcome of this, which created a different association with the concept of offering equal opportunity within the public sector. Today, the concept of Affirmative Action has become a debate in society with issues related to how far the equal rights should go. From one perspective, many believe there is the need for the law because of a lack of opportunities from minorities...
17 Pages(4250 words)Research Paper

Arrestees DNA Sample and the Fourth Amendment

... Arrestee’s DNA Sample and the Fourth Amendment One of the most controversial cases which the Supreme Court is about to decide is the case involving the Maryland DNA Collection Act (MDCA) which authorizes law enforcers to gather DNA samples from persons arrested for various crimes involving violence (US Supreme Court Media, n.d., p.1). In this case, DNA was gathered from Alonzo Jay King, Jr. who was arrested for assault charges and later on, the said DNA was logged onto the DNA database of Maryland discovering thereby that the DNA sample of King matched that of a rape case that has been unresolved (US Supreme Court Media, n.d., p.1). Such sample was the lone evidence used to convict King of first-degree rape by the trial judge who...
10 Pages(2500 words)Case Study

The Second Amendment of the US Constitution

...2nd Amendment to the U.S. Constitution The first interpretation of the Second Amendment of the US constitution by the Supreme Court was done on June 26, 2008. This was in a case involving the state of Columbia vs. Heller (2008). In its ruling the court stated that the Second Amendment of the US constitution n regards to traditional reasons that include self defence, grants an individual the right to possess a firearm. It further ruled that two of Columbia districts provisions that banned firearms and required disassembling of fire arms at home had violated the right granted by the Second Amendment (Acosta ). The original intent of the amendment The right to possess firearms is part of was proposed by the congress as a way of limiting...
11 Pages(2750 words)Case Study

5th Amendment Double Jeopardy

...5th Amendment Double Jeopardy Double Jeopardy, according to the Fifth Amendment s explicitly that one should not be subject for the same offence more than once putting in jeopardy life or limb (Jahncke, 1991); it is provided for by the constitution as a guarantee and it encompasses several protections. For one, it prevents the state from prosecuting and individual for a second time after they have undergone prosecution and subsequently being acquitted of a crime. Secondly the government is not allowed to prosecute someone for a second time for the same offense for which he has already been convicted; thirdly, the state cannot impose multiple penalties on the perpetrator of an offence in subsequent proceedings. The final provision...
13 Pages(3250 words)Research Paper

14th Amendment and Plural Marriages

The above case points at the numerous clauses, which the courts can turn to when ruing on cases pertaining to plural marriages. The above ruling was an indication of the changing attitude of the justice system towards peculiar groups and plural marriages. The existence of the equal protection clause provides an opportunity through which laws against polygamy or same-sex unions may be challenged.
There are several types of marriages, which include heterogeneous and homogeneous marriages. Plural marriages predominantly refer to a marriage where one male partner is union with more than one female partner (Seamon 11). Essentially, this type of union refers to polygamy. This form of marriage is widely unpopular in North America an...
6 Pages(1500 words)Assignment

The Fourth Amendment Appliance

...The Fourth Amendment protects every person’s house and papers from any unreasonable seizures by the government and so that no warrants areissued without any probable reason. Any warrant hat needs to be issued, is to be one under an oath or affirmation specifically describing the location and the person or thing which is to be seized. The Fourth amendment only allows such searches that are backed up by reason and according to the Supreme Court, having a reason is equal to having a warrant and therefore, warrantless searches breach the Fourth amendment. A warrant is only issued when there is a possibility of finding the evidence of a crime or if there is suspicion for someone. If however, the police violate this law and search a place...
6 Pages(1500 words)Assignment
sponsored ads
We use cookies to create the best experience for you. Keep on browsing if you are OK with that, or find out how to manage cookies.

Let us find you another Essay on topic Kefauver-Harris Amendment for FREE!

Contact Us