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LLW3000 Australian Administrative Law
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LLW3000 Australian Administrative Law
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Course Code: LLW3000
University: Victoria University
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Country: Australia
Question:
Mission Statement of the FDA. If the FDA has other “vision” statements or mottos, include those as well.
Delegation Authority and History of the FDA.
Clients and how the FDA’s mission helps define
Give Judicial Opinion that affected the FDA and how you believe the EO or Judicial Opinion impacted the FDA’s mission or function. (No specific date range required for your EO or opinion. Whatever you find that is important/relevant in your mind.)
Scenario:
Congress has passed and the President has signed a new statute under Title 6 U.S.C. (Homeland Security Statutes). Public Law 115-000, “Preparation and Neutralization In Case of Zombies Act” Or PANICZ Act. The PANICZ Act requires all agencies to have Zombie Apocalypse readiness plans. The PANICZ Act also requires all agencies to draft regulations and publish in the Federal Register rules related to the agency’s action in the case of an imminent or ongoing Zombie Apocalypse.
For this section of your annual report, you will draft a proposed rule for publication in the Federal Register. You may need to get creative, but that is okay! As long as your rule fits reasonably within your agency’s current status, it will count.
You will need to include in this section of your report the Proposed Regulation itself (look at Federal Register and the CFR for examples on how to structure the regulation/rule).
You will also need to include in this section the “Reasons” for the regulation. How does this rule or regulation work within the framework of the FDA’s mission, authority, personnel, clients and other considerations?
You will not need to do any of the typical analysis (financial, budget, regulatory analysis, paperwork reduction, etc) that agencies typically do.
Answer:
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 capability.
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 quality.
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 later.
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 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, 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 information.
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 body.
Clients
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 the Federal government regulate, encompassing the food, pharmaceutical and medical device industries.
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.
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 zombie.
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 people. 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.
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.
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