Annotations research topic statement and relevance significance

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 and benefits using the example of the 2009 Family Smoking Prevention and Tobacco Control Act. Similar to other federal agencies, FDA is required to evaluate the costs and benefits of its major regulatory actions like graphic warning labels. FDA’s regulatory system has major weaknesses that contribute to significant underestimation of benefits and overestimation of costs. The agency ends up significantly underestimating the net benefits of graphic warning label regulation and other regulations. One of the major limitations in FDAs regulatory system is its layered approach that involves third-party inspection agencies and actors. The information provided in this article will be used in the research statement and relevance section of this project. I will draw the reader’s attention to how FDAs regulatory system contributes to poor analysis of costs and benefits of major regulations.
Hamilton, C. & Raison, B. (2019, March 18). Understanding Food Labels. Journal of Agriculture, Food Systems, and Community Development, 8(4), 13-22.
The article discusses how food labels play an important role in consumers’ purchase decisions as they rely on such information. Federal regulators like FDA and USDA work together to ensure that food products are safe and healthy and information provided in food labels is accurate. Therefore, these agencies work to safeguard consumer interest by prohibiting misleading and false food labels. However, most of the terms used in these food labels by manufacturers and third-party inspection agencies are not regulated. This is an indicator of some gaps in regulatory process and system of federal regulators like FDA. The information provided in this article is suitable for understanding the regulatory processes by federal regulators like FDA as they seek to protect consumers. This information will be used in the research statement topic of this project to draw the reader’s attention to FDAs regulatory process.
Jenson, D., Lester, J. & Berman, M.L. (2016, April 21). FDA’s Misplaced Priorities: Premarket Review Under the Family Smoking Prevention and Tobacco Act. Tobacco Control, 25, 246-253.
This study uses the example of the Family Smoking Prevention and Tobacco Act to highlight the misplaced priorities of FDA. Based on existing laws, FDA needs to conduct a premarket review of new tobacco products before they are deemed suitable for sale. As a result, FDA implements its premarket review authorities and mandates. A review of recent FDA actions shows that the agency has not implemented its premarket review process in a way that prioritizes the safeguarding of public health. Consequently, this federal agency has weakened premarket review process, misallocated resources, and prioritized review of premarket applications over assessment of potentially non-compliant products on the market. The article includes many valuable points for use in this project, especially in the research topic statement and relevance and significance section. The research will draw the reader’s attention to how the focus on profits has contributed to FDA’s misplaced priorities.
Lang, T., Barling, D., & Caraher, M. (2009, Mar 19). Public policy and governance. In Food Policy: Integrating health, environment, and society (pp. 65-100) United Kingdom: Oxford University Press. Retrieved from https://oxford-universitypressscholarship-com.ezproxy.lib.ou.edu/view/10.1093/acprof:oso/9780198567882.001.0001/acprof-9780198567882-chapter-3.
The focus of this chapter is directed at the individual entities that govern or have a self-interest in various economic and industrial bodies. Governing bodies such as states or cities answer to a higher authority on matters of economic prosperity, growth domestic product (GDP), and population growth for revenue. Regulations are perceived as a restraint in the eyes of big business whose necessity it is to meet the bottom dollar expectation. An unknown number of corporate influencers view the practice of wasteful regulation payouts as a common payroll deduction. Consequently, the facilitating state or city entitles the entity with various amounts of tax cuts or insured business incentives. Within the context of economics, history, and education the discipline of this study focuses on business, humanities, and social sciences. Many valuable points within this research make a viable opportunity for use in the research topic statement and the relevance and significance of research section of this project. This study will redirect the readers' focus from the regulatory status of socioeconomics to the societal flaws marked by special interests.
Lupkin, S. (2020, January 14). FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find. National Public Radio. Retrieved from https://www.npr.org/sections/health-shots/2020/01/14/796227083/fda-approves-drugs-faster-than-ever-but-relies-on-weaker-evidence-researchers-fi
This article discusses the findings of researchers that FDA approval process for drugs is expedited but relies on weaker evidence. FDA has adopted different strategies and processes to accelerate its approval of new prescription drugs over the past four decades. However, the significant focus and investment in expediting drug approval has in turn compromised evidence relied upon by this federal agency. The faster approval based on weaker evidence shows the social implications of FDA’s regulatory framework in terms of social concerns of health and mortality. The article highlights valuable points regarding drug approval processes that will be used in the relevance and significance sections of this project. I will draw the reader’s attention to the legislative and regulatory changes and standards that promote faster approvals as well as the social implications of this trend on health and mortality.
Maffini, M.V., Neltner, T.G. & Vogel, S. (2017, December 20). We Are What We Eat: Regulatory Gaps in the United States That Put Our Health At Risk. PLoS Biology, 15(12), 1-8.
This article examines the regulatory weaknesses in the United States that endanger the health of populations. The analysis was carried out on the premise that America’s health system has changed, especially its regulatory framework. Since 1958, the American diet has continued to change dramatically after Congress gave FDA the authority to ensure the safety of food chemicals and products. However, the FDA has been sluggish in considering scientific knowledge regarding the effect of exposures as thousands of chemicals have entered the food system. The study will provide insights into gaps in FDA’s regulatory framework and approach. The information will be used in the relevance and significance section of this project. I will draw the reader’s attention to FDA’s inability to effectively manage chemicals entering the food system and inability to fully enforce its mandates in the layered regulatory framework.
Milestones in U.S. food and drug law history. (2018, Jan 31). Food and Drug Association [FDA]. Retrieved September 5, 2020, from https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/milestones-us-food-and-drug-law-history
This article explores the history and evolution of food and drug regulatory standards. In the 1800’s the United States commissioned the fist standards on drugs. Relatedly, the first known food laws became apparent overseas. During the 1800s the United States engaged chemists, physicians, and biologists to begin testing foods and drugs for formidable use by humans. Subsequently, formal importation, food and drug standards, committees, and inspections regulations developed. This study will provide insight into the humanities and social sciences through the context of history and law. The information will be used in the research and topic statement section of this project. I will draw the reader's attention to the inception of the concept of food and drug testing and regulation evolving into the FDA today.
Mueller, C. (1999, Mar). The regulatory status of medical foods and dietary supplements in the United States. Nutrition, 15(3), 249-251. Retrieved from http://dx.doi.org/https://www-sciencedirect-com.ezproxy.lib.ou.edu/science/article/pii/S0899900798001865?via%3Dihub
This author's study refers to questionable and misinformed categorization and labeling of medical and nutritional foods. Medical foods are specially formulated and used under the supervision of a physician or at the physician’s orders by medical personnel. These foods contain formulas to act as non-hazards to persons with diabetes, gastric bypass, or food allergies to name a few instances. Regarding social stigma, medical foods contain little to no product development requirements. Consequently, many medical foods are available at most food outlets just as dietary nutrition supplements. Dietary supplements are a vague understatement for products other than tobacco. Realistically, supplements are anything that can be ingested by humans to increase daily intake or compensate for lack of absorption. This research focuses on the disciplines of natural and applied sciences and will be used in the relevance and significance section of my project. I will implore the reader to focus attention on the fallacies that private organizations and the FDA consider nullified by circumstances of deregulations and accountability.
Wallach, J.D., Ross, J.S. & Naci, H. (2018, June 5). The US Food and Drug Administration’s Expedited Approval Programs: Evidentiary Standards, Regulatory Trade-offs, and Potential Improvements. Clinical Trials, 15(3), 219-229.
This article explores the various regulatory programs and pathways established by FDA to accelerate the development and approval of therapeutic agents for treatment of life-threatening or serious conditions. One of the common attributes of these programs is regulatory flexibility, which permits for a customized approval approach. This approach facilitates market authorization based on less rigorous evidence in exchange for demanding post-market evidence generation. The article provides an overview of the evidentiary standards required by FDA and concludes that the agency’s approvals are based on less evidence from fewer and smaller studies instead of focusing on clinical outcomes. The information provided in this article will be used in the relevance section of the present study. I will implore the reader to the gaps in FDA’s approval process and how they endanger the health and safety of populations.