Drug Approved By The FDA Essay

Drug Approved By The FDA Essay

Drug Approved By The FDA Essay

Choose a drug that has been approved by the FDA within the past year.

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Write a 1,000-1,250 word paper in which you:

Describe the drug approved by the FDA. Include the pharmacodynamics and pharmacokinetic properties of the chosen drug.
Provide an overview of the disease state for which the drug is used.
Describe what is different about this agent compared to currently available therapies.
Discuss the potential risks associated with this agent and any monitoring parameters that are necessary.
Decide whether you would personally prescribe this agent or stick with currently available alternatives.
You are required to cite five to 10 sources to complete this assignment. Sources must be published within the last 5 years and appropriate for the assignment criteria and nursing content.Drug Approved By The FDA Essay


The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter. When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the…show more content…
During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. Phase 2 Clinical Studies – Helps determine the common short-term side effects and risks associated with the drug. Phase 3 clinical studies – Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years. Although the FDA prolongs this process for safety concerns, I personally feel that they should be able to expedite their approval. The reason for expedition is because more and more people are being diagnosed with multiple health issues. Some people are more desperate then others and feel they can benefit from the drug as it is. Drug Approved By The FDA Essay

There are many direct to consumer advertising for prescription drugs. On television, magazines, radio etc, you see the most recent advertisements for prescription drugs. After some people see the advertisements they soon rush over to their doctor and their illness and life would be perfectly pain and stress free. Making the public conscious of options for treatment is not a bad thing. But these false advertisements are misleading consumers onto unnecessary treatment. Advertisements have one primary purpose that is to persuade. Prescription medications Ads tell the consumers to get treatment and also imply that they have the need for it to solve their problems. Since prescription Ads have been introduced, the pharmaceutical…show more content…
Merck will soon face many challenges in the business of producing drugs. The company’s most popular drugs are coming to a close to their patent expiration. One of the best selling drugs is called Zocar, which is used for cholesterol problems. Zocar will have to soon face competition next June from other generic drug makers. The elimination of Zocar from the market will erase the $5.2 billion sales annually. Fosomax, an osteoporosis relieving drug, produced by Merck will soon lose the$ 2.2 billion annual sales because of the expiration of its patent. Also, another problem is the struggles recently to find new medicines. The prescription painkiller drug, which was introduced in 1999, is called Vioxx. Vioxx was introduced by Merck and co. Vioxx served the purpose of being a painkiller in the relief of osteoarthritis, rheumatoid arthritis, painful menstruation and other types of acute pain. This painkilling drug would be classified as a non-inflammatory drug (NSAIDs).Drug Approved By The FDA Essay

Food and Drug Administration (FDA)

The FDA has many responsibilities which include overseeing the production of

safe foods and the manufacture of safe and effective drugs and medical devices. The

FDA has responsibility for protecting the rights and safety of patients in the clinical

trials of investigation medical products. The FDA also has to review and approve in a

timely manner the safety and efficiency of new drugs, biologics, medical devices, and

animal drugs. They have to monitor the safety and effectiveness of new medical

products after they are marketed and acting on the information collected. The FDA is

responsible for seeing that the public has access to truthful and non-misleading product

information by: monitoring the promotional activities of drug and device manufacturers,

and regulating the labeling of all packaged foods.Drug Approved By The FDA Essay

Science is a big part of the FDA organization. The scientific evidence needed to

back up FDAs legal cases is prepared by the agencies 2,100 scientist, including 900

chemist and 300 microbiologist, who work in 40 laboratories in the Washington, D.C.,

area and around the country. Some of these scientist analyze samples to see, or

example if products are contaminated with illegal substances. Other scientist review

test results submitted by companies seeking agency approval for drugs, vaccines, food

additives, coloring agents and medical devices. The FDA also operates the National

Center for Toxicological Research. They investigate the biological effects of widely

used chemicals. The agency also runs the Engineering and Analytical Center, which

test medical devices, radiation-emitting products, and radioactive drugs. Assessing

risk, for drugs and medical devices, weighing risks against benefits is at the core of

FDAs public health protection duties. By ensuring that products and producers meet certain standards, FDA protects consumers and enables them to know what they are

buying. In deciding whether to approve new drugs, FDA does not itself do research,

but rather examines the results of studies done by the manufacturer. The agency must

determine that the new drug produces the benefits its supposed to without causing

side effects that would outweigh the benefits.

In 1992, the U.S. Congress passed the Prescription Drug User Fee Act. This

legislation provided additional resources …

… middle of paper …

…f the drugs should be approved. Once the FDA approves the drug, it

does not mean it is perfectly safe. Some medicine may have side effects, but the FDA considers

both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling

outlines the benefits and risk reported in the tested population. For a drug to be approved by

CDER, by current law, all new drugs need proof that they are effective and safe before they can

be approved for marketing. CDER decides as quickly as a thorough evaluation allows. When a

proposed drug’s benefit outweighs know risk, CDER considers it safe enough to approve. Once

a drug gets the CDER approval, the drug is on the market as soon as the firm gets

ing costs for medications in the United States. In 2000, the average retail price of a

One of the oldest U.S. consumer protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards. As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States. It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation’s blood supply.Drug Approved By The FDA Essay

To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action. Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways.

The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the scientific evidence to back up its regulatory and inspection duties. These scientists analyze samples of products for purity and review test results of new products. The FDA itself does not do research for a new medical product. Instead, it evaluates the results of studies undertaken by the manufacturer.Drug Approved By The FDA Essay

Food production in the United States has been regulated since the late eighteenth century. Colonies and, later, states passed laws banning impurities from selected foods. In 1848, the United States began regulating imported drugs, under the Drug Importation Act (Ch. LXX, 9 Stat. 237). The enforcement of food and drug laws was first assigned to the Chemical Division of the new u.s. department of agriculture (USDA) in 1862 (12 Stat. 387).

Encyclopedia 1080
The need for laws to regulate food and drug purity became increasingly urgent in the late nineteenth century, when substances such as opium, cocaine, and heroin were commonly added to medicinal elixirs and tonics. The need for government regulation was also made evident in Upton Sinclair’s book, The Jungle, which exposed the unsanitary conditions of Chicago’s meatpacking industry and shocked the nation. On June 30, 1906, Congress, with the support of President theodore roosevelt, passed two landmark pieces of Progressive Era legislation that strengthened the government’s ability to protect consumers: the Food and Drug Act (34 Stat. 768 [21 U.S.C.A. § 1–15]) and the Meat Inspection Act (21 U.S.C.A. § 601 et seq.). The former prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs, and the latter addressed the unsanitary conditions and use of poisonous preservatives and dyes in the meatpacking industry.Drug Approved By The FDA Essay

In 1927, Congress authorized the creation of the Food, Drug, and Insecticide Administration within the U.S. Department of Agriculture. In 1930, the agency’s name was changed to the current one, Food and Drug Administration (Agriculture Appropriation Act, 46 Stat. 976).

In 1937, 107 people died after taking the elixir sulfanilamide, a supposedly healing tonic. This tragedy prompted the passage of the next major reform of food and drug law, the Federal Food, Drug, and Cosmetic Act of 1938 (21U.S.C.A. § 301 et seq.). The FDA was then entrusted with the regulation of cosmetics and therapeutic devices and was authorized to do factory inspections. Even more importantly, the act required new drugs to be tested on animals and humans for safety before being marketed. In 1957, the Food Additives Amendment (Pub. L. 85-250, Aug. 31, 1957, Stat. 567) required the evaluation of food additives to establish safety, and in the following year, the Delaney Clause (Pub. L. 85-929, Sept. 6, 1958, 72 Stat. 1784) forbade the use in food of substances found to cause cancer in laboratory animals.Drug Approved By The FDA Essay

The Food and Drugs Authority in the U.S has a responsibility of ensuring that the country has a safe and reliable drug supply. For a number of years, the general consensus has been that all drugs that FDA approves are effective and safe, and that they treat the relevant illnesses that they are produced for. In delivering its service, FDA has strict rules and laws that act as a guideline to all its operations. These laws cannot be changed to suit individual interests. It is illegal for pharmaceuticals that are unapproved by FDA to be imported into the country as this undermines the duties of the Authority.
Accordingly, the authority is tasked with the duty of ensuring that all drugs used in the territory of America are approved and prescribed to promote effectiveness (Fain et al. 1259). The role the Authority plays in analyzing the quality and effectiveness of a drug cannot be underrated. Without this check, the market would be flooded by substandard drugs from manufacturers that seek to benefit from unsuspecting clients. The Authority takes responsibility whenever a case arises where a citizen uses a drug that is not approved by FDA. Because of this, the Authority should always ensure that all drugs that are imported meet the basic standards. The legality of a drug within America depends on whether the Authority has approved it or not. Because of the strict rules of the Authority, it would be illegal for Sally to be allowed to import the drug. The Misuse of Drugs Act of 1977 creates an offence for any person importing a drug to America without the approval of FDA (Lang et al. 32). The only way that Sally can have the drug is by travelling out of America and coming back with the drug for personal use as opposed to public use.Drug Approved By The FDA Essay

Sally’s Position
I understand that although FDA has strict rules against importation of unapproved drugs unto America, there are some exceptions under which patients are allowed to import drugs for personal use.

Personally, I think I meet this criteria
The agency has developed a guideline on the Regulation Procedures Manual that addresses personal importations. In this guidance, FDA sets out the priorities in enforcing new drugs that are unapproved. In strict terms, enforcement of importing such drugs is meted to people who do so for commercial purposes and with the intention of defrauding the public. This is because such a move is likely to pose a serious health risk to the public, hence the reason adequate care should be taken. In essence, FDA has exceptions as to when one can be allowed to import drugs that are unapproved for medical reasons.Drug Approved By The FDA Essay
First, FDA recognizes that one can be allowed to import such drugs for personal use in a case where one had begun treatment in a foreign country using the unapproved drug (Submission et al. 86). When such people move to the United States of America, they will be allowed to receive the drug, provided they prove that they intend to use it for personal treatment. A person who suffers from a serious problem or condition in which FDA lacks approved treatment is allowed to import such a drug.
In my case, FDA lacks the relevant drug to treat the condition that I am currently suffering from. In such circumstances, I have the right to import the drug and in addition, I believe that FDA is restricted from taking a legal action against me. I also understand that such flexibility is not binding, and, therefore, is to the discretion of FDA (Submission et al. 86). However, based on all the facts that I have provided, I should nevertheless be allowed to import the drug because FDA does not have an approved method of dealing with such conditions in the United States of America.Drug Approved By The FDA Essay

Letter from FDA to Sally
Dear Sally,
Please understand that for a new drug to be used in the United States of America, it must go through the Investigational New Drug (IND) approval. During this process, agencies seek to determine whether the drug (product) is safe for human use. It is also during this process that a determination is made as to whether the product justifies commercial development within the stipulated rules (Stringer, 748).
Agents of a drug company that seeks approval from FDA to sell it in United States must subject the drug to various tests. First, the drug is subjected to laboratory tests to determine its components and whether it has potential risks (Stringer, 748). The drug is then subjected to animal tests to determine the impact it has on living organisms. After the tests on animals, the drug is then tested on humans to determine the effect it has. It is during this test that FDA determines the safety and effectiveness of the drug in treating or diagnosing a certain condition.Drug Approved By The FDA Essay
Drug tests are followed by the company in question sending an application to FDA. This application is referred to New Drug Application (NDA). However, not all drugs are approved through NDA. Drugs that are biological in nature seek approval through the Biological License Application. Whichever method the company may decide to use, the application must meet some basics. It has to provide the test results of the drug. The company should provide manufacturing information to ensure it is properly used. It is also important for the company to provide the drug’s proposed label (Stringer, 751).
These are the procedures that are in place and therefore, they must all be followed. If you met this criteria then you may be allowed to import the drug.Drug Approved By The FDA Essay


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