Federal Drug Administration Dilemma Essay

December 10, 2022

Federal Drug Administration Dilemma Essay

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Type of Project	ESSAY
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Format	APA
Academic Sources	10
Page Count	3-12 PAGES

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Federal Drug Administration Dilemma Essay

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Federal, Drug, Administration, Dilemma, Essay

This is an example of an ethical dilemma. Under the Federal Drug Administration (FDA), manufacturers are not supposed to disclose the results of medical research to the public domain (Kesselheim& Mello, 2007). On the other hand, manufacturers have a moral obligation to disclose the research information to the public, especially since the drug is now linked to cancer.

As the manufacturer, I would voluntarily disclose the study information to the public but under conditions. The FDA requires the drug manufacturers to undergo a long, expensive, and a multistep process that takes many years and includes numerous clinical on human subjects (Unlu, 2009). The manufacturer then files for investigational new drug application with the FDA.

After the approval, the manufacturer continues with the human trials before filing a New Drug application (Unlu, 2009). In summary, the process of manufacturing drugs is laborious and time-consuming. All along, manufacturers pay for their cost of research data generation (Kesselheim& Mello, 2007). For this reason, research data should be kept confidential.

I would, therefore, disclose information that will not put our organization at risk. I would contact the Federal Drug Administration and ask for guidance on the best way forward before disclosing the information. Disclosing the research data promote public interests by getting rid of costs that result from keeping research data out of reach of the public.

Unlu (2009) found that Merck did not disclose research information about its Vioxx’s after reports indicated that the drug was posing cardiovascular risks to patients. Disclosing the research information would boost the customers’ trust, a move that would make the company earn more. Since it is only preliminary research, it will allow the customers to evaluate the effectiveness of the drug and make an informed decision on whether to continue using our products (Kesselheim& Mello, 2007).

In summary, I would be more than willing to disclose the research information concerning our product since it is only preliminary research. I would, however, ensure that I protect the confidential information that would put the company at risk of losing the trade secrets.

According to me I would volunteer from myself and will disclose the information. Based on two grounds I would do that and if the information is ethical then the information can be disclosed to the customers. Based on the research from the history the breast implants which are covered here in this text will not be difficult for spotting a similar pattern here. Based on the full disclosure only the choices would be made by the buyers and they will require whole market information.

About the drugs, there will be information in the firms, and this will not be available or the purchasers. The final disclosure needs to be made not only from the ethical perspective, but they should also take from the litigation perspective. Here are some of the allegations which are raised on the fertility drugs that result in ovarian cancer. Based on the research we can to know that these drugs are been used by most women where this results in cancer (Kravdal & et al, 2017).

Correlation between Ovarian Cancer and Fertility Drugs

In the United States, most of the women have been suffered due to this drug and it causes cancer. Based on the researchers by many people I came to know that due to infertility this drug leads to cancer and harms many women’s health and increases the risks. For this problem there should be a treatment and infertility increased the need of treatment where all other health care systems are trying to play with the people’s health using some fertility drugs.

This raised a lot of consequences. The factor per se of infertility has been leading this cancer issue because they are using this fertility drug as their medication and this has come to know on the study research. To Vitro fertilization, this cancer is mainly related to and the changes which are made in this increase the fertilization were in increases the risks (QingAn & et al, 2018).

Conclusion

Cancer will possess to everybody through the use of the fertility drugs unusually where this is one of the drugs which decreases the fatal of a person (Roti & et al, 2014).

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RUBRIC

Excellent Quality

95-100%

Introduction

45-41 points

The context and relevance of the issue, as well as a clear description of the study aim, are presented. The history of searches is discussed.

Literature Support

91-84 points

The context and relevance of the issue, as well as a clear description of the study aim, are presented. The history of searches is discussed.

Methodology

58-53 points

With titles for each slide as well as bulleted sections to group relevant information as required, the content is well-organized. Excellent use of typeface, color, images, effects, and so on to improve readability and presenting content. The minimum length criterion of 10 slides/pages is reached.

Average Score

50-85%

40-38 points

More depth/information is required for the context and importance, otherwise the study detail will be unclear. There is no search history information supplied.

83-76 points

There is a review of important theoretical literature, however there is limited integration of research into problem-related ideas. The review is just partly focused and arranged. There is research that both supports and opposes. A summary of the material given is provided. The conclusion may or may not include a biblical integration.

52-49 points

The content is somewhat ordered, but there is no discernible organization. The use of typeface, color, graphics, effects, and so on may sometimes distract from the presenting substance. It is possible that the length criteria will not be reached.

Poor Quality

0-45%

37-1 points

The context and/or importance are lacking. There is no search history information supplied.

75-1 points

There has been an examination of relevant theoretical literature, but still no research concerning problem-related concepts has been synthesized. The review is just somewhat focused and organized. The provided overview of content does not include any supporting or opposing research. The conclusion has no scriptural references.

48-1 points

There is no logical or apparent organizational structure. There is no discernible logical sequence. The use of typeface, color, graphics, effects, and so on often detracts from the presenting substance. It is possible that the length criteria will not be reached.