Comprehensive Report: The US FDA's Role in Public Health and Safety

This report provides an overview of the United States Food and Drug Administration (FDA), a federal agency responsible for protecting public health through the regulation and supervision of food safety, drugs, medical devices, and other related products. The report details the FDA's mission and vision, highlighting its commitment to ensuring the safety and effectiveness of food and medical products. It explores the delegation of authority within the FDA, outlining how power is transferred and the responsibilities associated with it. The report also delves into the historical context of the FDA, tracing its origins back to the 1906 Pure Food and Drug Act and its subsequent evolution. Furthermore, it examines the organizational structure of the FDA, including its various directorates and their core functions. The report touches on alternative dispute resolution procedures within the agency, the Freedom of Information Act procedures, and whistle-blower protection. Finally, it discusses a recent court case involving the FDA and a news story related to harmful chemicals in food packaging, underscoring the agency's critical role in safeguarding public health and the potential risks of its elimination; solved assignments like this are available on Desklib.

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Student’s Name
Affiliation
Instructor
Date
United States Food & Drug Administration
The United States Food and Drug Administration is considered to be a federal agency in
the Department of Health and Human Services in the United States. It is mainly tasked with
the protection of public health through the supervision and control of food safety, dietary
supplements, tobacco products, over the counter and subscription drugs as well as medical
devices and blood transfusion, (Olutoye 99). For it to be effective and independent, it was
empowered by the American Congress so that it can enforce Drug, Federal Food, and
Cosmetic Act.
1. Foreword of the US Food and Drug Administration
i) Mission Statement
The agency aims at protecting consumers as well as enhancing the entire public health
system through the maximization of products that are regulated by FDA as well as r3educing
risks that may be or are associated with the products.
ii) Vision
The Food and Drug Administration ensures that all food in America is safe and all
medical products administered are effective and safe for consumption. As a result, the entire
public health system is protected and advanced, (Singh 06).

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2. Delegation authority
The authority provides for the delegation of power and authority. This is guided by the
Staff Manual Guide 1401.1 which came into effect in 2011. In addition, a delegation of
authority is provided by the FDA staff manual guide volume 2. Its purpose is the setting out
of procedures relating to the delegation, (Welch, John and Sandra). As a result of the
delegation, legal importance is realized with particular attention being directed on how the
agency operates. The Food and Drugs Administration officers are given the opportunity to
convey authority to members of the subordinate staff so that activities are carried according
to law. On the other hand, officers how to go against the law are held accountable for their
actions.
Secretaries have certain authorities which include making and issuance of reports to the
Congress and the President. Secondly, they approve and issue various regulations. Lastly,
secretaries establish committees and advisory councils as well as appointing their members
too. Commissioners also have authorities. A secretary to the Agency as well as an official
from the Administrative program gives Commissioners authority. Re-delegation of these
powers is restricted by law. In re-delegation, the Secretary empowers the Commissioner with
authority to perform duties such as described under the Drug, Federal Food and Cosmetic Act
21, International Cooperation section 307 and authorization of individuals undertaking
research. Other activities include the recording and reporting of essential information.
Providing mandates that relate to safer vaccines, manufacturers recordkeeping as well as
reporting and review warnings, precautionary information and user instructions. During the
delegation of authority, power is transferred from one person to the other and as such, duties
and responsibilities that have been delegated must be done accordingly and lawfully. In that

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regard, liability falls on the individual when he or she goes against certain laws and
procedures governing the authority bestowed upon him or her.
3. History of the Food and Drug Administration
The Food and Drug Administration began its journey in 1906 under the establishment
of the first food and drug safety bill called the 1906 Pure Food and Drug Act. This was done
so that food could be regulated in the country. During the Industrial Revolution, medical and
food production was on the rise hence the need for a law that could regulate the sector.
Medicines and medical equipment being invented needed regulation and patenting hence the
establishment of this body. Harvey Wiley is known to be one of the first advocates for
regulation of foods and drugs. By uncovering harsh work conditions and poor production
conditions of food in many industries across eh United States, the Pure Food and Drug Bill
was signed into law in 1906. Being called the Willey Act, amendments were made to it and
this was later transformed into the Food and Drug Administration as it is called today.
4. The organizational structure of FDA
The organization is made up of an office of the Commissioner as well as other four
directorates, the directorates oversee the core functions allocated to the agency which include
overseeing medical productions, tobacco, Global Regulatory Operations and Policy, Foods as
well as Operations, (Olorunfemi 2491).
5. Personnel statistics (number of people employed, positions included)
In the Agency, there are 1, 082 employees under the Centre for Food and Applied
Nutrition, 3, 603 in Drug Evaluation and Research, the Centre for Biologics Evaluation and
Research has 1, 074 whereas the Office of Regulatory Affairs has 5, 068 employees.

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6. Alternative Dispute Procedures
Science and policy are mainly used in the resolution of disputes in the agency. Here, the
Ombudsman is one option for solving disputes that arise. In most cases, it is advised that
problems are first discussed with the Division Director or review team hence solving the
issue before it escalates, (Bersoff-Matcha 795). For instance, when an individual has a
dispute with a certain management system, the procedure entails the inclusion of a Director.
It is stipulated that professional judgments should be adopted by employees. In a scenario
where there is a problem, the Next Higher Level Management Official should be notified so
that the issue is resolved. A statement has to be recorded and signed by all parties involved,
(Gimenez 1868). In case the disputant is not satisfied, he may appeal against the decision
made by notifying the director.
7. Freedom of Information Act procedures
Requests are sent by mail which is then received by the Department of Freedom of
Information in the Food and Drug Administration. By using a decentralized system, each
query is answered accordingly depending on the kind of question. Initial fees are also made
so that processing is done and in most cases, this does not exceed $250. Records are then sent
via mail.
8. Discussion of whistle-blower cases arising from “leaks”
The Agency supports the Whistle-blower Protection Act which gives employees the right to
put forward claims of mistreatment, dissatisfaction about the work environment or any
disputes that may not be resolved by the agency, (Downing 1856). By also adhering to civil

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rights statutes, the agency provides an environment that is free and fair to its employees and
other stakeholders.
9. Discussion of a court case involving your agency
The most recent case which is still pending entails the FDA and Brown and Williamson
Tobacco Corporation. Brief facts herein state that the FDA is entitled to regulate food and
tobacco. This is a matter that made Brown and Williamson Tobacco Corporation sue the
Agency over regulation policies, (Food and Drug Administration). The claim was that FDA
does not have jurisdiction to regulate tobacco and its products especially when therapeutic
benefits are not realized. Initially, the District Court penalized the agency for overstepping its
mandate. The court of Appeals went ahead to uphold the initial judgment thus making FDA
lose the case, again.
10. Discussion of a recent news story involving FDA
The New York Times this month published an article on how certain foods contain chemicals
which are harmful to children. This was found out after tests on foods that were stored in
plastic containers and wrappings, on the other hand, the agency advocates for new solutions
which will reduce the usage of plastic bottles and bags thus reducing the occurrence of
diseases, especially in children.
11. Final summary discussion of why the United States government should not eliminate
your agency/department
It is essential that the government takes into account how important this agency is.
For instance, many companies, if given a chance, will manufacture goods while aiming at
profits and not the health concerns of its consumers. By eliminating this agency, consumers

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will face a lot of risks since they do not have the capacity to check and test for harmful
substances. Also, production of medicine will not be regulated and many patients will not be
helped in the long run. With this, there is a need for strengthening the agency rather than
looking for loopholes so that it can be scrapped.

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Works Cited
Food and Drug Administration. "FDA drug safety communication: FDA warns of increased
risk of death with IV antibacterial Tygacil (tigecycline) and approves new boxed
warning." US Food and Drug Administration, Silver Spring, MD (2017).
Downing, Nicholas S. "Post market safety events among novel therapeutics approved by the
US Food and Drug Administration between 2001 and 2010." Jama 317.18 (2017):
1854-1863.
Bersoff-Matcha, Susan J. "Hepatitis B virus reactivation associated with direct-acting
antiviral therapy for chronic hepatitis C virus: a review of cases reported to the US
Food and Drug Administration Adverse Event Reporting System." Annals of internal
medicine 166.11 (2017): 792-798.
Olorunfemi, Odunayo. "LETS PUT THE TRIALS TO A TEST: A 23 YEAR REVIEW OF
UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) RECORDS OF
CARDIOVASCULAR DISEASE CLINICAL TRIALS." Journal of the American
College of Cardiology 11.69 (2017): 2491.
Welch, Hanna K., John A. Kellum, and Sandra L. Kane‐Gill. "Drug‐Associated Acute
Kidney Injury Identified in the United States Food and Drug Administration Adverse
Event Reporting System Database." Pharmacotherapy: The Journal of Human
Pharmacology and Drug Therapy (2018).

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Gimenez, Maria Rubini. "Impact of the US Food and Drug Administration–Approved Sex-
Specific Cutoff Values for High-Sensitivity Cardiac Troponin T to Diagnose
Myocardial Infarction." Circulation 137.17 (2018): 1867-1869.
Olutoye, Olutoyin . "Food and Drug Administration warning on anaesthesia and brain
development: implications for obstetric and foetal surgery." American journal of
obstetrics and gynaecology 218.1 (2018): 98-102.
Singh, Henry. "Abstract GS5-06: A US food and drug administration pooled analysis of
outcomes of older women with hormone-receptor positive metastatic breast cancer
treated with a CDK4/6 inhibitor as initial endocrine based therapy." (2018): GS5-06.