Mission, Vision and Functions of the FDA

This article discusses the mission, vision, and functions of the FDA, its history, organizational structure, personnel, and clients. It also talks about the impact of the 2-for-1 Executive Order and the proposed regulation for Zombie Apocalypse Readiness Plan.

Running head: ADMINISTRATIVE LAW
Administrative Law
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Mission, Vision and Values of the FDA
The Food and Drug Administration (FDA), US is a noted federal agency of the United
States Department of Health and Human Services. This department is on the executive
departments of the country’s government. The mission of FDA is to foster protection of the
consumers and augmenting overall public health through maximization of compliance of FDA
regulated products and minimizing of risk associated with the products.” This agency has its
main role in protection of public health by ensuring the security, efficacy and safety of human
and veterinary drugs, medical devices and biological products. The prime accountability of FDA
to make sure that the food supply of the nation maintains safety standards. FDA further has the
aim of regulating the manufacturing, marketing and distribution of tobacco products with the
underlying notion of protecting public health. In addition, the organization is accountable for
considering advancements in the public health through significant innovations in the field of
medical products so that safer, more effective and affordable products can come into existence.
The public is also helped by the FDA to receive science-based accurate information pertaining to
medical products and food. Lastly, FDA has a major role in the Nation's counterterrorism
capability1.
The vision of FDA is that every individual in the country has access to food that is safe,
medical products that are effective and, public health is protected and advanced. FDA has set in
place the core values that are adhered to for fulfillment of the mission. These are accountability,
commitment to public health, communication, diversity and inclusion, integrity and respect, and
quality2.
1 "What We Do". Fda.Gov, 2018, https://www.fda.gov/aboutfda/whatwedo/. Accessed 1 July 2018.
2 Inspections Foreward. U.S. Food And Drug Administration, Office Of Regulatory Affairs, 2018,
https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM291748.pdf. Accessed 1 July 2018.

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Delegation Authority and History of the FDA
The origin of FDA is related to the time when the Agricultural Division in the Patent
Office came into existence in 1848. Nevertheless, the organization became a federal consumer
protection agency upon the implementation of the Pure Food and Drugs Act came into existence
in 1906. This law came into enforcement as an amalgamation of around 100 different bills that
came into existence over nearly 25 years. These had the aim of reining the venerable and solemn
abuses experienced in the context of marketplace of consumer products. The Act had been a
strong response to the manufacture, sale and transportation of adulterated, poisonous,
misbranded, or deleterious drugs, foods, and liquors. The need of forming FDA was realized
significantly for upholding consumer protection laws and enhancing consumer safety. The
Harvey Washington Wiley had shown repetitive support to the Federal public health protection,
who was the chief chemist of the Bureau of Chemistry of the U.S. Department of Agriculture,
FDA’s predecessor. The Act passed in 1906 after he put in immense efforts as an answer against
the infuriate condition put forward by the public against unhygienic conditions.
In 1927, reorganization was considered in the regulatory powers of Bureau of Chemistry under a
new USDA body, the Food, Drug, and Insecticide organization. The name Food and Drug
Administration (FDA) came into existence almost three years later3.
Operations/Functions
The health and wellbeing of individuals across the world have been profoundly and
positively influenced by the implementation of evidence based approaches undertaken by the
3 "When And Why Was FDA Formed?". Fda.Gov, 2018,
https://www.fda.gov/AboutFDA/Transparency/Basics/ucm214403.htm. Accessed 1 July 2018.

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FDA. The organization in collaboration with different regulatory bodies throughout the globe has
come up with diverse and critically significant contributions to health and safety of the
individuals. The FDA addresses its mission through providing leadership and oversight in
relation to protection of public health. The domains that the FDA oversees are human and
veterinary drugs, biological products, cosmetics, medical devices and products that emit
radiation. The four functions of the FDA are to undertake promotion of health through review of
research; to ensure drugs and foods are safely labeled; to work with nations for reducing the
burden of regulation; and to cooperate with scientific experts and consumers for effectively
carrying out the obligations.
The scope of FDA’s regulatory authority has been noted to be extensive. While the
responsibilities and functioning of the same are much related to that of other government
agencies, FDA has certain additional functioning to fulfill. FDA regulates foods including
bottled water, dietary supplements, food additives, infant formulas; drugs, both prescription and
non-prescription; biologics, including vaccines, blood, cellular and gene therapy products, tissue
products and allergenics; medical devices; electronic products such as X-ray equipment,
microwave ovens, laser products and ultrasound therapy equipment; cosmetics such as nail
polish and color additives in products; veterinary products such as pet foods and livestock feeds;
tobacco products such as cigarettes and smokeless tobacco.
Organizational Structure
FDA is a renowned agency within the Department of Health and Human Services and
consists of the Office of the Commissioner and four directorates overseeing the core functions of
the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy,

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and Operations. Leadership is a prominent activities of the Office of the Commissioner. The
agency focuses on scientific activities, legislative liaison, policy planning, women’s health
initiatives, agency operations and toxicological research. The Office of Foods and Veterinary
Medicine is responsible for overseeing a functionally unified FDA Foods Program addressing
food and feed safety and nutrition along with other significant areas drawing attention of public
health agendas. The Office of Global Regulatory Operations and Policy holds accountability of
providing leadership for domestic and international efforts of FDA to ensure product safety and
quality. The Office of Medical Products and Tobacco is responsible for providing advice and
suggestions to the Commissioner on the tobacco-related issues and programs. The role of Office
of Operations is linked with provision of agency-wide services such as financial management,
information technology, library services, procurement, FDA history and freedom of
information4.
Personnel
The Commissioner at FDA is Scot Gottlieb with 4 deputy commissioners working with
him. The Chief Financial Officer is James Tyler and the Chief Information Officer is Todd
Simpson. The Chief of Staff, Chief Scientist and Chief Counsel are Lauren Silvis, Denise Hinton
and Rebecca Wood respectively. 8 Associate Commissioners, 8 Assistant Commissioners and 8
Center Directors are also part of the governing body5.
Clients
4 "FDA Organization". Fda.Gov, 2018, https://www.fda.gov/AboutFDA/CentersOffices/default.htm. Accessed 1
July 2018.
5 "FDA Leadership Profiles". Fda.Gov, 2018, https://www.fda.gov/aboutfda/centersoffices/ucm193757.htm.
Accessed 1 July 2018.

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FDA has been serving the needs of different agencies for the public health mission.
Through leveraging of expertise and resources, along with appropriate mechanisms, The clients
of FDA are Centre for Biologics Evaluation and Research, Centre for Devices and Radiological
Health, Center for Drug Evaluation and Research, Center for Food Safety and Applied Nutrition,
Center for Tobacco Products, Center for Veterinary Medicine, and National Center for
Toxicological Research. FDA has been effectively working with the clients for addressing
critical health gaps and fostering innovation in products regulated. Both financial resources and
human resources have been provided to the clients to fulfill the common aim of improved public
health.
Discussion of Executive Order that affected the FDA
The American president Donald Trump’s 2-for-1 Executive Order has had a deep impact
on the FDA. On January 2017 the White House had issued an executive order entailing agencies
and executive departments to “identify at least two regulations to be repealed whenever they
propose or promulgate a new regulation”. Precisely, the Executive Order entails the total
incremental costs of any new regulation to be offset by the elimination of the costs related to the
repealed regulations. As a response to the Executive Order the FDA needs to exercise cautious
decision making. Against the mission of the FDA to protect health of the public, the Order brings
in challenges for the organization since actions proposed for the future would need to be
considered at the side of two current actions that were had been previously issued with the aim of
promotion of public health. In my opinion the 2-for-1 rule is not a common approach in context
of change of administration. The same would introduce much uncertainty into the markets that

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the Federal government regulate, encompassing the food, pharmaceutical and medical device
industries6.
Proposed Regulation
The proposed rule for the publication in the federal register for the agency’s current status is as
follows. The preparation and the neutralization in the case of Zombies act include the Zombie
Apocalypse readiness plans for drafting the actions for an ongoing and imminent Zombie
Apocalypse. The purpose of the proposed rule is to prepare the real world for the emergencies
and issues arising from the zombies.
The objective of the rule or the regulations in this context includes the zombie neutralization by
the deception, denial, destruction or degradation.
Title: Zombie Apocalypse Readiness Plan
Chapter: The regulations and the rules of the agency
Part: This is a regulation in the platform for prohibiting the drastic effects of zombie apocalypse.
Section: The main level of navigation towards the protection on human life and prohibition of
the general assault on the civilization.
Paragraph: The Food and Drug Administration on its annual report of 2018 draft a proposed rule
for the ongoing apocalypse of the zombies.
 To organize a safe one for the none infected people in the purpose of encouraging them to
start a new life.
6 "‘Two Out, One In’: Trump Signs Executive Order To Repeal Regulations". Raps.Org, 2018,
https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/1/%E2%80%98two-out,-one-in
%E2%80%99-trump-signs-executive-order-to-repeal-regulations. Accessed 1 July 2018.

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 To ensure to keep away people from zombie bites and zombie infected water, air, food,
and drug. It should furthermore be ensured that no individual keeps any connection or
sexual relation with an infected person or a zombie7.
 To ensure and keep a track that the parasitic organisms cannot cause any zombifications
by ensuring proper killing of their hosts and reanimation of their corpses.
 To initiate periodic checking of services and factors that has the tendency to affect
people8. These includes supply of piped water, shutdown of electrical power,
contaminated drugs, expired food in the province, unhealthy living condition,
disproportionate amount of drug intake, food scavenging and pre industrial hostile
wilderness.
 To identify the sources of the epidemiology of the infections that causes zombification
and the need for further research in the field of medication for the prevention of the
problem.
 To recognize and analyze the symptoms of infection for the zombie outbreaks and
development of vaccines for effective provision of the proper containment of the infected
zombies for successful prevention of the infected individual from reverting to zombiism.
7 Kruvand, Marjorie, and Fred B. Bryant. "Zombie apocalypse: can the undead teach the living how to survive an
emergency?." Public Health Reports 130.6 (2015): 655-663.
8 Smith, Tara C. "Zombie infections: epidemiology, treatment, and prevention." Bmj 351 (2015): h6423.

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References
"‘Two Out, One In’: Trump Signs Executive Order To Repeal Regulations". Raps.Org, 2018,
https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/1/%E2%80%98two-
out,-one-in%E2%80%99-trump-signs-executive-order-to-repeal-regulations. Accessed 1 July
2018.
"FDA Leadership Profiles". Fda.Gov, 2018,
https://www.fda.gov/aboutfda/centersoffices/ucm193757.htm. Accessed 1 July 2018.
"FDA Organization". Fda.Gov, 2018,
https://www.fda.gov/AboutFDA/CentersOffices/default.htm. Accessed 1 July 2018.
"What We Do". Fda.Gov, 2018, https://www.fda.gov/aboutfda/whatwedo/. Accessed 1 July
2018.
"When And Why Was FDA Formed?". Fda.Gov, 2018,
https://www.fda.gov/AboutFDA/Transparency/Basics/ucm214403.htm. Accessed 1 July 2018.
Inspections Foreward. U.S. Food And Drug Administration, Office Of Regulatory Affairs, 2018,
https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM291748.pdf. Accessed 1 July
2018.
Kruvand, Marjorie, and Fred B. Bryant. "Zombie apocalypse: can the undead teach the living
how to survive an emergency?." Public Health Reports 130.6 (2015): 655-663.
Smith, Tara C. "Zombie infections: epidemiology, treatment, and prevention." Bmj 351 (2015):
h6423.