The Food and Drug Administration
The Food and Drug Administration (FDA) is a federal agency that has monitored the quality of food and drugs in the United States of America since 30 June 1906. FDA is an agency in the Department of Health and Human Services. Since then, the company has had changes in its system to accommodate This paper gives an overview of the FDA’s formal structure, organizational culture, organizational leadership, critical elements of the FDA’s environment, and changes a hypothetical CEO would make to improve the company’s efficiency.
The Organization’s Formal Structure
FDA is an agency in the Health and Human Services Department. It consists of nine centers and thirteen new offices that play different roles in the company. The centers include Biologics Evaluation and Research, Devices and Radiological Health, Drug Evaluation and Research, Food Safety and Applied Nutrition, Tobacco Products, Veterinary Medicine, Toxicology Research, Regulatory Affairs, and Operations. Offices include Digital Transformation, Chief Counsel, Chief Scientist, Clinical Policy and Programs, Executive Secretariat, External Affairs, Food Policy and Response, Minority Health and Health Equity, Operations, Policy and International Affairs, and Office of Women’s Health.
The Center for Biologics Evaluation and Research has regulated the production and distribution of safe biological products such as cosmetics, food, and drugs. The Center for Devices and Radiological Health promotes public health by ensuring proper medical products and practices. For instance, FDA provided new standards that regulate the amount of radiation emitted from imaging devices such as X-rays (Miller et al., 2021). The Center for Food Safety and Applied Nutrition ensures quality in locally produced, imported, and exported food items. Besides protecting human health, FDA ensures safety and quality in animal products such as feeds through the Center for Veterinary Medicine. Additionally, the Center for Tobacco Products controls the growing of tobacco, manufacturing, advertising, and distribution of tobacco products. Tobacco is a legal drug in the United States of America, even though it is harmful to people’s health. FDA is responsible for approving drugs that should be affordable and effective through the Center for Drug Evaluation and Research.
Moreover, the FDA’s Office of Digital Transformation aims to deliver high-quality, secure, and efficient information technology and data solutions that help the agency promote and improve human health. The Chief Counsel’s Office comprises legal professionals, consultants, and support staff. They have defense lawyers that handle civil and criminal regulatory matters and defend the FDA when establishing rules and making judgments. The Office of External Affairs acts as a liaison between the FDA and professionals and the general public to address issues and meet concerns these groups have about FDA policies and programs.
FDA’s objective is to safeguard consumers’ health, safety, and wallets by enforcing laws enacted by the United States Congress and regulations issued by the agency. The United States’ leading food and drug legislation are the Federal Food, Drug, and Cosmetic Act. It is the most significant law in the world, with multiple modifications. The law ensures that foods are pure and wholesome, safe to eat, and produced in hygienic conditions. The FDA ensures substances and equipment are safe and reliable for their stated purpose; that beauty products are safe and created from suitable condiments; and that all branding and labeling is factual, insightful, and not misleading.
In FDA, power is highly centralized, with the Office of the Commissioner being the highest level of power in the organization. The offices and centers answer to the Office of the Commissioner. As of April 2022, the following were in the Office of the Commissioner:
- Robert M. Califf is the managing director of the Commission of Food and Drugs.
- Janet Woodcock is the deputy managing director.
- Julia Tierney is the chief of staff in the Office of the Commissioner.
FDA’S Organization Culture
The FDA’s organizational culture is employee-centered, giving them a conducive workplace to perform effectively. The distinguishing feature of the FDA from other agencies is that it is employee-centered. According to Anthony Lee, a Regulatory Officer in the Food and Drug Administration, he loves being around his office because of the job satisfaction offered by the company. The company protects the employees’ rights and makes them know of their importance in protecting the general public from harmful items. According to the functionalism concept, a company needs rules, beliefs, and values to function correctly (Champoux, 2010). Values, beliefs, and collaborations are also made to ensure a proper environment that spearheads scientific research, regulation of products, and approval of safe items in the market. The FDA fraternity lacks jargon and rituals as they want to maintain professional standards.
The other characteristics incorporated in FDA are cultural inclusivity, transparency, quality, safety, collaboration, and organization.
- Cultural inclusivity: The FDA website considers Spanish natives in the United States of America by including a Spanish version of the information. According to studies, the United States of America has the second largest number of Spanish-speaking natives globally, despite being an English-speaking country. Therefore, many Spanish speakers should be aware of the FDA’s mission, organization, and policies in the comfort of their language.
- Transparency: FDA provides candid data through its website about its current progress, employees, and operations, such as the approval of drugs. The general public can access this data, showing how FDA considers transparency.
- Innovation: The organization facilitates research to improve awareness about quality products. For instance, the organization established the Oncology Center of Excellence (OCE) on 17 January 2016. The body oversees many research and educational outreach projects and activities to advance the production and control of cancer-related medical products (de Claro et al., 2021). According to a review, cancer treatment products undergo a strict public submission process to the FDA, ensuring efficient oncology products are on the market (de Claro et al., 2021). This move also creates numerous job opportunities for people in STEM courses.
- Quality: The Food and Drug Administration plays a crucial role in maintaining the quality of food and drugs manufactured and distributed. It regulates the manufacturing and distribution of quality products that meet the FDA standards. It also maintains quality in how it operates and the standards the centers formulate.
- Safety: FDA ensures the safety of the employees and the general public. It works on educating the public on standard products and those they should avoid for their safety. The FDA provides research material in their site which is accessible by everyone, and facilitates research which ensures students and interested groups are aware of various safety regulations.
- Collaborations: The FDA has partnered with organizations such as Cooperative Research and Development Agreements (CRADAs) to solve primary public health needs and overcome scientific gaps by utilizing skills and resources via proper methods, driving innovation in the goods the FDA regulates.
- Organization: The FDA uses innovative and forward scientific research to create standards and approve items. For instance, the FDA would use scientists to test the product and ensure its viability in approving a drug. The scientists then bring their findings to the Office of the Commissioner, and the product may either get approval or be declined. There are much deliberation and involvement of various departments when FDA is working on a particular product, but the final decision is centralized.
FDA’S Organizational Leadership
Power in the FDA is centralized, with Robert Califf leading the organization to commit to its departmental goals. The offices offer administrative services while centers are for research, formulation of policies, and implementation. There are also oversights boards for every center that ensure the centers meet their objectives and give a green light on various matters. Looking into the gender gap, FDA has minimized the gender disparity in leadership roles, thus, utilizing the feminist social concept of empowering women. For the offices, the leadership is comprised of Robert M Califf who is the commissioner and overall head of the company. He ensures the execution of company rules and policies. Janet Woodcock is the deputy managing director and works in the Office of the Commissioner. She oversees day-to-day functions and the implementation of company initiatives. Julia Tierney is the Chief of Staff who also works closely with other leaders in the organization to ensure the implementation of company policies and strategies. These are the top leaders in the FDA.
Additionally, Mark Raza is the head of the Office of the Chief Counsel, where he leads great minds that advises the agency on the proper steps to take, steps that would benefit the public. Vid Desai is the leader in the office of Digital Transformation and leads the company’s information technology strategies. James Tyler is the Chief Financial Officer responsible for budgeting, accounting, and allocating funds to various projects like scientific research and equipment and provides risk management strategies. The FDA’s Acting Chief Scientist is Jacqueline A. O’Shaughnessy. She is in charge of directing and coordinating the FDA’s bridge public and professional health initiatives. James Sigg is the Deputy Commissioner for Operations and Chief Operating Officer at the Food and Drug Administration (FDA). He oversees the FDA’s global operations, including ethics, employment equity, human resource management, staffing, protection, infrastructure, procurement, and budget planning and reporting.
FDA offers a transparent overview of its decision-making process through its website. For instance, in the approval of a drug, the Center for Drug Evaluation and Research (CDER) reviews the drug’s effects and potential negatives on the targeted patients. CDER first analyzes the condition the drug is designed to relieve and the other options that can relieve the condition. The center then experiments on the drug to establish its clinical benefits and risks, such as adverse side effects. They then strategize on whether the benefits outweigh the risks; if so, the drug is forwarded for approval by providing facts and figures proving it is worth approving. The Oversight Board then meets monthly to discuss emerging issues and expertise needs. Here, the CDER can explain the reason for the approval of a particular drug. The drug is then approved. Each center makes its decisions which are then forwarded to the Oversight Board and documented for future references.
Aside from protecting the general public, the FDA is concerned with its employees’ welfare. It is crucial to have a good working environment and ensure employee satisfaction for the company to perform efficiently. The organization offers incentives such as paid leave, including public holidays, a premium health insurance cover, and life insurance. When the employee is sick or the employee’s next of kin, they are offered a sick leave. The company also has a pension plan and other retirement programs. One can say that FDA is a good employer.
Most Critical Element of FDA’s Environment
FDA plays a vital role in the federal government; thus, it requires a conducive environment of support, funding, and research for it to be able to pursue its objectives. The Food and Drug Administration (FDA) safeguards and maintains the safety and wellbeing of all Americans by expanding access to safe medical goods and foods and encouraging innovation to solve unfulfilled clinical and public health needs. The FDA also ensures the provision of safe animal medication products and food, which protects and promotes the health and safety of animals. FDA is a scientific, regulatory organization that is vital. FDA was established in 1906 as one of our country’s primary consumer product safety agencies and is currently in charge of ensuring the safety of biologics, such as blood products and vaccines, pharmaceuticals, healthcare equipment, foods, and beauty products.
FDA has devised a strategic plan for developing new tools, regulations, and methodologies to assess the safety, effectiveness, quality, and performance of FDA-regulated goods, to fulfill this requirement of a proper working environment. For instance, the FDA sets performance requirements, reviews marketing authorization applications for creating and improving risk tobacco products, requires updated safety warnings, and enforces advertising and promotion limits under the Family Smoking Prevention and Tobacco Control Act. This strategy outlines eight critical areas of regulatory science whereby new or increased collaboration is critical to the FDA’s public health and regulatory mission’s sustained success. The following are the top priorities for the FDA’s environment:
- Toxicology should be modernized in order to improve product safety. The company uses new technology such as Ultra-High Performance Liquid Chromatography (UHPLC) equipment to detect toxins by establishing standards that conform to the toxin’s retention time.
- Improve product development and patient outcomes by promoting clinical evaluations and personalized medicine innovation.
- New approaches to improving product production and efficiency are encouraged by accommodating new views and eternal research.
- Ascertain that the FDA is capable of assessing new emerging technologies such as radiation-emitting medical equipment.
- Improve health by using information from multiple sources through information sciences.
- To protect the public’s health, devise a new health and safety system that focuses on prevention.
- Assist in developing medical remedies to protect the United States and international safety and welfare from threats.
- Enhance psychosocial science to assist consumers and experts in making rational choices regarding regulated products.
Another element of the FDA environment is working around regulation policies. FDA shields the general population from the harmful radiation emitted by electrical products. According to the FDA standards, cosmetics and dietary supplements are supposed to be safe and labeled correctly. FDA is in charge of regulating tobacco product manufacture and distribution. The Food and Drug Administration contributes to the advancement of public health by assisting in the rapid development of new products. The 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, and other American territories are all within FDA’s jurisdiction. The agency controls many substances such as dietary items like additives, supplements, infant formulae, over-the-counter drugs, prescribed ones, and biological items like sperms and blood donated. FDA regulates medical machines and other electronics, especially those that give off radiation like the x-ray equipment. FDA controls cosmetics like lipsticks, tobacco products like electronic vapes, and veterinary products like pet food. Therefore, there should be policies and rules that ensure proper regulation of substances.
Appropriate Changes in the Organization
With the development of new drugs, discovered illnesses, and new technology, the FDA should keep tabs on emerging changes to stay relevant and meet people’s needs. As an aspiring CEO, one of the needed changes in the FDA is the approval of inexpensive and highly beneficial drugs and regulation of pharmaceutical products that may sell a gimmick of helping people. However, these companies are out to make a profit only.
One of the things the FDA should enforce is the approval of drugs that should be affordable and effective through the Center for Drug Evaluation and Research. FDA requires the use of the interactionism social concept to understand the market and its needs. Some newspaper articles question the work of the FDA, such as the “Furor rages over FDA approval of controversial Alzheimer’s drug” post by the Washington Post by Lauren McGinley. According to the article, the agency approved the drug as its trial treatments showed the reduction of amyloid, a compound in the brain that inhibits communication between brain cells which is a factor for Alzheimer’s (McGinley, 2021). It is up to the FDA to approve effective drugs worth their price tag.
Moreover, the company should incorporate the interactionism social concept, which enables the company to first interact with people, know their needs and create policies that fit the general public. Alzheimer’s treatment is a new venture in the medical field, and many people are skeptical about the new drug. The general public was infuriated by the drug’s treatment price, which would cost $65,000 a year. Following Marxism’s theory, the organization should foster equality (Champoux, 2010). Many middle-class and poor people would love to afford Alzheimer’s drugs, but they would not afford a drug that costs as much as an average household earns in a year. By regulating the drug’s pricing to meet everyone’s needs in the country, Alzheimer’s patients will equally get treated.
Market Regulation of Products
Nonetheless, many pharmaceutical companies have come up with vaccines, and after vaccines, they introduced boosters, which seemed like a market play for many consumers that which FDA should regulate. The FDA should apply the postmodernism social concept, ensuring that the company supports the people in line with international situations. For instance, if there are FDA offices based in Australia, FDA is tasked with ensuring they meet the employees’ affairs in that country. Therefore, the FDA should consider these employees and take care of them.
Accommodation of External Views
Nevertheless, the organization should consider the social action theory, which allows other people’s views and argues with proven facts. For instance, the FDA would ask itself, “Is a second coronavirus booster necessary for the general public?” Another newspaper article by The New York Times, “FDA Allows Second Coronavirus Boosters for Everyone 50 and Older,” reports on the FDA’s allowance of another booster (Lafraniere, 2022). To the public, a second booster shot is unnecessary. However, FDA announced its approval of the advocate showing the need for 50-year-olds and older to take it four months after the first booster. Additionally, the company should facilitate increased research to help get new insights and promote the production of high-quality products. This facilitation of research is essential in creating awareness, financing research projects, and educating people on the primary ways of preventing illnesses. The research facilitation helps in providing quality products. The organization should regulate the products in the market that may be deemed unnecessary.
Champoux, J. E. (2010). Organizational behavior: Integrating individuals, groups, and organizations. Routledge. Web.
de Claro, R. A., Gao, J. J., Kim, T., Kluetz, P. G., Theoret, M. R., Beaver, J. A., & Pazdur, R. (2021). US Food and Drug Administration: Initial experience with the real-time oncology review program. Clinical Cancer Research, 27(1), 11-14. Web.
Lafreniere, S. (2022). FDA allows second coronavirus boosters for everyone 50 and older. The New York Times. Web.
McGinley, L. (2021). Furor rages over FDA approval of controversial Alzheimer’s drug. The Washington Post. Web.
Miller, D. L., Kakar, S., Jiang, L., Spelic, D. C., & Burk, L. (2021). The US Food and Drug Administration’s role in improving radiation dose management for medical X-ray imaging devices. The British Journal of Radiology, 94(1126), 20210373. Web.