Foods and Medications Approval

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 who are most likely to use the drug, the pharmaceutical company can get approval for the drug as its side effects will not be fully demonstrated. The trials conducted are only done long enough to show the main effects but not to detect the side effects. Therefore, when the drug starts being used by patients, they will have side effects that have not been indicated and this will negatively affect their lives. Understanding the interaction of a drug in the body is vital as it demonstrates how the drug will affect different people and drugs with harmful effects will not be approved (Light, Lexchin, & Darrow, 2013).

Business

Pharmaceutical companies are in the business of making and selling drugs for profit. Therefore, their main focus is on getting people to use the drugs they manufacture. The more people who use a drug the better for the company. With this in mind, the companies will make use of underhanded tactics to get their drugs approved even when the drugs have harmful effects on the users. The companies will only submit to the FDA results that demonstrate a drug is effective and can be used for the treatment of a certain condition (Barber IV & Diestre, 2019). What they never exclude is that the drug has certain side effects. However, these side effects are considered normal and the adverse ones are not listed. The FDA will then act based on this data as it does not have the resources to be analyzing and testing drugs on human subjects before it approves them. As has been shown by (Light et al., 2013), two in seven new drugs have side effects serious enough to warrant action by the FDA. Sadly, this never happens as the FDA is limited in terms of approval and drug testing. Forcing the company to rely on the results presented by drug companies to approve drugs.

Annotated Bibliography

Abraham, J. (2008). Sociology of pharmaceuticals development and regulation: a realist empirical research programme. Sociology of health & illness, 30(6), 869-885.

The researcher focuses on the sociological impact of the relationship between pharmaceutical companies and regulatory agencies. There is a bias formed at the macro- and meso-levels, which manifest itself at the micro-social level. Using a relist sociology analysis, the researcher has managed to show how regulatory agencies are influenced by pharmaceutical companies to approve drugs. Commercial interests have overshadowed and taken over the science away from the interests of the consumers resulting in drug injuries.

Barber IV, B., & Diestre, L. (2019). Pushing for speed or scope? Pharmaceutical lobbying and Food and Drug Administration drug review. Strategic Management Journal, 40(8), 1194-1218.

This paper demonstrates how pharmaceutical companies make use of political activities to push for the approval of their drugs. Pharmaceutical companies have used their political capital to push for the review and approval of drugs manufactured by the company. This results in the FDA receiving undue pressure to have certain drug approvals expedited. The end result of this is drugs do not undergo the full review before they get the final approval. Pharmaceutical companies use social behavior to push legislators to have their drugs approved faster than those of their competitors. Faster drug approval means some drug will be approved and result in harmful effects 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 the pharmaceutical companies over the needs of the public.