LAW2504 Administrative Law

Pursuant to Public Law 000-001, passed by both esteemed houses of Congress and signed by President Donald Trump on April 30, 2018, the Committee for Administrative Redundancy Eradication (CARE) was formed.

 

As prescribed by law, CARE contains members of both Congressional houses and equal members of both primary parties of the esteemed Congress of the United States.

 

As prescribed by law, the mission of CARE is to examine all federal departments and agencies and provide a report to the esteemed houses of Congress and the White House with detailed recommendations of federal departments and/or agencies which may be eliminated or consolidated in an effort to promote a leaner, more efficient government structure.

 

As the head of your federal department/agency, you are hereby directed to submit a letter in response to this request with the following information:

 

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.

Foreword of the US Food and Drug Administration

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.

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).

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 regard, liability falls on the individual when he or she goes against certain laws and procedures governing the authority bestowed upon him or her.

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.

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).

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.

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.

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.

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 rights statutes, the agency provides an environment that is free and fair to its employees and other stakeholders.

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.

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.

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 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.

References

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).

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.