Social Responsibility of the FDA Annotated Bibliography

Responsibility and Awareness of Regulatory Status

The responsibility or lack thereof concerning the Food and Drug Administration (FDA) to the public is cause for concern and is of personal interest. Regulations and deregulations are important as a father, husband, and member of the community for personal views that I hold. First, a loved one has a red meat allergy that has been disregarded by pharmaceutical companies and the FDA. Secondly, she is employed by the local hospital and observes a concerning number of individuals with like immunocompromising deficiencies. If the FDA standardizes and regulates suppliers instead of third-party inspection agencies, millions of others like her may conclude viable alternatives in the United States and abroad. The FDA’s inability to regulate effectively can transform personal relationships adversely.

A review of academic literature consists of detailed analysis and observations concerning regulatory schemes. In 1938 the Federal Food, Drug, and Cosmetic Act was introduced with the intent to regulate adulterated foods, medicines, and cosmetics from entering United States consumer’s hands (Milestones in U.S. Food and Drug Law History, 2018). In 2011 congress and the president signed the FDA Food Safety Modernization Act (FSMA) into law due to the inherent gaps and oversight of supply chain and manufacturing regulations since the last significant update in 1938 (Administrative Law, 2012). As a result, local governments have become autonomous third-party actors in layered FDA regulation (Lang, Barling, & Caraher, 2009). Consequently, autonomous deregulation and special interest have created but are not limited to significant misunderstanding in supposed policed medical foods, nutritional supplements, and ingredients therein (Mueller, 1999). The resultant produces an environment of devious agenda and profit-focused entities (Lang et al., 2009). While observing gregarious regulation, the distinction underlying the facts continues to blur.

Significant research exists regarding the local, state, and federal regulations of the food and drug product details. Furthermore, details of the impacts on society have become surmounting. However, little understanding of the arrangements in which these agreements conclude exists. The purpose of this research project is to explore when the FDA was conceived to become a regulating committee, why the regulator and subsidiaries exist if blurred distinctions exist, and how the leader in approval along with third-party actors continue to implore acceptable and unacceptable social welfare decisions. Permitting, the FDA’s claim to have Americans lives primarily as their focus, this author will argue that big business, special interests, and monetary gain present superior pursuits instead.

Relevance and Significance of Research

Relevance to Organizational Leadership

The FDA’s inclusive nature of integrating policies and regulations for population standards relate to significant issues within my degree plan of Organizational Leadership. While an effective partnership is required in this situation, the notion of placing third-party inspection agencies between the FDA and critical suppliers continues to present misunderstandings of policy standardizations. FDA collaborates with other federal bodies like USDA to safeguard customer interest. However, terms used by third-party inspection agencies and manufacturers to obtain consumer favor are not regulated (Hamilton & Raison, 2018). Jenson, Lester & Berman (2016) state that FDA’s regulatory approach has been characterized by misplaced priorities as the organization misallocated resources in different areas such as smoking prevention and tobacco control. The agency ended up substantially underestimating the benefits and overestimating the costs of graphic warning labels for cigarettes and smokeless tobacco products (Chaloupka et al., 2015).

As a result, what could be socially viable constructs is affected by the layered regulatory approach adopted by FDA and its subsequent challenges like corruption. Elitists within the view of the world’s population exemplify a double standard of regulation abiding by which law accepting citizens are crucified and condemned. It is the agenda of self-interest suppliers and consumers to benefit from the undereducated or uninformed individuals for purposes including but not limited to monetary gain and self-indulgence. The self-interest of suppliers and third-party inspection agencies has become counter-productive for FDA as there are more treatments and cure on the market but less evidence of their safety and effectiveness (Lupkin, 2020). Most of FDA’s expedited programs are approved based on less evidence from fewer and smaller studies without random allocation and comparator groups (Wallach, Ross & Naci, 2018).

Consequently, additional research about the avenues and interests of the FDA and its subsidiaries' motives will help me be an effective leader in an organization. Insights obtained from the research can be helpful in the career of a management analyst, which is one of the professions a person graduating from the Organizational Leadership program can pursue. Management analysts work in the business consulting profession where they help enhance organizational efficiency, profitability, and productivity by suggesting improvements. The results of this research would help a management analyst understand how to enhance organizational integrity, which is critical for one to become an effective leader in an organization. The study would enhance insights into how to promote organizational integrity for effective leadership through formation of effective partnerships with third-parties for bilateral adherence.

The FDA’s Regulation Initiation Linked to Various Professions

The FDA, its plethora of worldwide subsidiaries, and the decision-making process not only impact a multitude of professions but, they compel organizations to follow their decision processes. First, the influence of the FDA and its global partner, the World Health Organization (WHO), molded precedence for political agreements such as the North American Free Trade Agreement (NAFTA) by accepting global suppliers and acquiring overseas subsidiaries (Lang et al., 2009). The initiative created an environment of empowered government factions but maintained the “status quo” or less for small business owners and farmers. Secondly, the influence of state notes the city of Gary, Indiana’s air pollution due to steel production did not create concern due to local agendas (Lang et al., 2009). According to Administrative Law (2012), courts demonstrate concern over local regulatory accountability and the possibility of reduced culpability. Whether pursuing a career in logistics, management, law, manufacturing, healthcare, or other business-related fields, more research about the FDA, its subsidiaries, and approval processes may provide insight to anyone pursuing a degree in Organizational Leadership.

Social Implications of the FDA’s Decision Making

Approval practices by which federal regulators such as the FDA employ approval of a product presents an unmatched significance on social concerns of health and mortality. Refusing to consider facts and implications resulting in the wellbeing of anyone may be a consideration for negligence (Jenson, Lester & Berman, 2016). To emphasize this point, deregulation and climate-imposed exemptions on termed “medical foods” and “nutritional supplements” have regulated labeling requiring a physician or equivalent to oversee consumption become nullified (Mueller, 1999). Consequently, medical foods and questionable strengths of nutritional supplements, or as they are called now “dietary supplements” are sold at open market retail outlets and grocery stores. Moreover, subsidiaries, actors, or third-party regulators are not legally required to disclose their statutory interpretations or methodologies to the superseding federal oversight committee (Administrative Law, 2012). Businesses with attention focused primarily on proprietary information in the context of how it manufactures and delivers its product to a consumer may show little interest in other than obligatory standards. The United States is faced with a weakened regulatory system relating to drug safety and effectiveness because of decade-long systemic problems that have made it difficult for FDA to fully enforce its mandates (Maffini, Neltner & Vogel, 2017). This weakened system comprises numerous third-party inspection agencies and limited resources for federal regulators (Lang et al., 2009). The effect of greater understanding and partnership with government and federal regulators will provide an acceptably harmonized relationship with societal embrace.

Annotated Bibliography

Administrative law: FDA Food Safety Modernization Act, § 3885. (2012). Harvard Law Review, 125(3), 859-866. Retrieved from https://www-jstor org.ezproxy.lib.ou.edu/stable/41349894?sid=primo&seq=1#metadata_info_tab_contentsThe focus of this study is to educate readers about the ramifications and implementations that the government was compelled to enact. Before 2011, certain gaps in the FDA’s authority had been overshadowed since its inception in 1938. Due to a lack of authority in some instances, food, drug, and supplement borne illnesses became regretfully common. Many native food and drug companies claimed to have direct quality process oversight of their manufacturing processes. Overseas trade exporters of drugs that claim to make the product cheaper and more efficiently experienced less than assumed inspection upon delivery. Authority and efficiency were essential for the FDA to keep up with safety, security, and demand. This study focuses on the discipline of the social sciences in the context of law and education. This reference will be utilized within the research topic statement section of this project. I will direct the readers' attention to the vulnerabilities that the FDA faces behind a government facade to an oblivious populace.

Chaloupka, F.J., Warner, K.E., Acemoglu, D., Gruber, J., Laux, F., Max, W., Newhouse, J., Schelling, T. & Sindelar, J. (2015, March). An Evaluation of the FDA’s Analysis of the Costs and Benefits of the Graphic Warning Label Regulation. Tobacco Control, 24(2), 112-119.

This article examines how FDA analyzes graphic warning label regulation costs…