Verified Document

Foods And Medications Approval Capstone Project

Interdisciplinarity of Research of the FDA, its Subsidiaries, and Decision Making

Interdisciplinarity is defined as the combination or combining of two or more academic disciplines to achieve a common task. Using interdisciplinarity a person can make connections between concepts and ideas across different disciplinary boundaries. By drawing knowledge from several disciplines one can address a problem effectively and thoroughly. There are cases where one approach would not be suitable for a particular problem and using interdisciplinarity the researchers are better suited to tackle the problem at hand. Combining the perspectives of two or more disciplines a researcher can understand a complex subject. As is the case with the attempt to understand the multitude of ways the Food and Drug Administration (FDA) and its subsidiaries approve foods and medications with regard to big business, money priorities, and political interests. This is a complex subject that can only be understood by combining aspects from different disciplines like sociology, psychology, biology, and business. By combining insights from these disciplines, we will understand the complexity involved in the regulatory process and understand how the FDA approves medications.

Sociology

The structure of the FDA comes to question when one thinks about the sociology of its drug approval. It has been shown that most of the regulatory employees begun their careers in the pharmaceutical industry (Abraham, 2008). This means they have 'friendly relations' with the industry and this has an effect on their drug approvals. Due to career development, regulators will try to maintain the 'friendly relations' with industry as they will have plans to head back to industry or vice versa. In this case, the regulatory agency is prioritizing the interests of the industry over the interests of the consumer. While the FDA was formed to serve the interests of the public. It has over time started to serve the interests of pharmaceutical companies. This has resulted in the drug approval process being expedited and long-term drug effects being overlooked (Busfield, 2006).

Psychology

Employees of the FDA have links to pharmaceutical companies. These links were formed when the employees started their careers in the pharmaceutical companies and then progressed to regulatory work....

For most of these regulators, they still have friends in pharmaceutical companies and these so-called friends can influence them to approve drugs. It is human nature to favor a friend over a stranger. This comes to play as FDA regulators tend to believe the data submitted by pharmaceutical companies regarding the effects of a drug (Mukherji, Janakiraman, Dutta, & Rajiv, 2017). Considering that the FDA cannot review each drug submitted for approval, it will tend to believe the data submitted and approve drugs based on the data (Barber IV & Diestre, 2019). There are unconscious cues that a regulator will have towards a company they have worked for in the past and this will result in them trusting the company and pushing for their drug to get approval.

Biology

Drug interactions in the body are different for each person. Pharmaceutical companies know this and they tend to make use of healthy individuals when testing their drugs (Sun et al., 2017). This reduces the impact of negative results and ensures the data produced regarding the drugs is mostly positive. Without proper research being conducted to determine the efficacy of a drug on poor, unhealthy, or old people...

…to the patients.

Busfield, J. (2006). Pills, power, people: sociological understandings of the pharmaceutical industry. Sociology, 40(2), 297-314.

The researcher focuses on the scientific fact making involved in the clinical trials of drugs. The clinical trials are the basis for securing approval from the FDA before the drug can be released to the market. By understanding what goes on in the clinical trials it becomes clear that the pharmaceutical companies will at times prefer to only demonstrate the positive effects of a drug over the negative side effects. Of course, with positive side effects the drug can get faster approval. The paper has noted pharmaceutical companies are in business and their concern is profit making. Therefore, they will be more concerned on how they can get approvals and not on the impact of the drugs on the users.

Light, D. W., Lexchin, J., & Darrow, J. J. (2013). Institutional corruption of pharmaceuticals and the myth of safe and effective drugs. The Journal of Law, Medicine & Ethics, 41(3), 590-600.

The researchers have focused on the harmful side effects of some of the drugs that have received approval by the FDA. The paper shows how the pharmaceutical companies have corrupted the practice of medicine as they have influence over the drugs being developed, their testing, and the drugs medical knowledge. Since drug companies pay authorization of user fees and they are FDA's prime clients, they can control and push for expedited drug approval. This reduces the time taken to review a drug and the FDA does not have enough time to fully review the evidence presented by the drug companies. The FDA has focused on meeting the needs of…

Sources used in this document:

Mukherji, P., Janakiraman, R., Dutta, S., & Rajiv, S. (2017). How direct-to-consumer advertising for prescription drugs affects consumers' welfare: A natural experiment tests the impact of FDA legislation. Journal of advertising research, 57(1), 94-108.

The FDA allowed drug companies to directly market to consumers and this has resulted in increased prescription drug sales, which creates an overdependence on drugs by the population. The pharmaceutical companies have contested they use the advertisements to increase consumer knowledge. However, we all know the effect of advertising is to increase sales of the advertised drugs. The researchers have analyzed the impact of direct to consumer advertising and have shown it has increased consumer dependence on pharmaceutical drugs. This has in turn affected the body's immune system.

Sun, J., Wei, Q., Zhou, Y., Wang, J., Liu, Q., & Xu, H. (2017). A systematic analysis of FDA-approved anticancer drugs. BMC systems biology, 11(5), 1-17.

The researchers are pushing for the repurposing of currently FDA approved drugs. This would reduce the cost of new drugs and the need for reapproval. Consumers would also benefit as the drugs will be more effective as compared to the current ones and they might be cheaper than the ones currently in the market. However, pharmaceutical companies would prefer to develop new drugs based off the existing drugs and market them as better than the existing ones. This in essence results in overpriced drugs that will have increased negative side effects. Also, the new drugs are not tested against the existing ones, they are tested against placebo drugs. This makes the new drug seem effective.

Cite this Document:
Copy Bibliography Citation

Sign Up for Unlimited Study Help

Our semester plans gives you unlimited, unrestricted access to our entire library of resources —writing tools, guides, example essays, tutorials, class notes, and more.

Get Started Now