For these assignments, you will take on the role of a consultant for a government agency. Your consulting firm has been asked by the agency to conduct research, compile a report, and pr

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Rationale and Analysis for Agency Selected

Gabrielle McNeely

PAD530

Strayer University

Phillip Neely

10/22/2023

Rationale and Analysis for Agency Selected

Introduction: History, Mission, Objectives and Functions

The Food and Drug Administration (FDA) depicts the oldest protection agency for consumers in the United States, where since 1848, it was incorporated in monitoring agricultural products safety (United States Food and Drug Administration, 2023). The responsibility was first accomplished in 1862 by the Department of Agriculture, and later, and the FDA took the role. Its present name was initialized in 1930, and the modern regulatory functions of the FDA started after the inclusion of the Pure Food and Drugs Act (1906). The formation of the law took half a century, significantly prohibiting interstate commerce, including misbranded and adulterated drugs and foods, and was contributed by Harvey Washington Wiley. From then, the FDA changed in terms of political, economic, legal, and social changes. An oral history program in the mid-1970s provided an opportunity to capture FDA’s employees' memories approaching the end of their career path in Food and Drug. Lewis Caleb contributed the Food and Drugs commissioner position in 1848 while conducting chemical investigations in the agricultural division in the Department of Interior patent office. The initial Agriculture commissioner, Isaac Newton, incorporated a chemical division from the Patent Office's former chemical laboratory, forming the Chemistry Division in 1890. Charles Wetherill was, therefore, appointed as the chemist in 1862 and mainly focused on improving fertilizers and the wine industry, and later started the investigation of agricultural commodities adulteration. The appointment of Harvey Wiley as the initial Chief Chemist was in 1883. The below flow of history depicts its transitioning:

Food Drug and Insecticide Administration- 1927

Food and Drug Administration (FDA) – 1930

FDA transfer from USDA to the inclusion in the Federal Security Agency- 1940

FDA transfer to the Department of Health Welfare and Education -1953.

Forming the Department of Health and Human Services -1979.

FDA's mission is the protection of public health by ensuring efficacy, safety, veterinary, human drugs, medical devices, and biological devices safety (United States Food and Drug Administration, 2023). Alternatively, the FDA serves the objectives of regulating the marketing, distribution, and manufacturing of tobacco products for the protection of public health and reducing tobacco use among minors. FDA also depicts the responsibility of advancing public health by supporting speed innovations that make medical products safer, effective, and affordable and helping the public gain science-based information in improving health. It also has a responsibility for the counterterrorism capability of the Nation by ensuring food supply security and fostering medical product development in responding to natural and deliberate public health threats.

Agency Functions

FDA performs regulatory responsibilities in regulating foods, drugs, biologics, medical devices, electronic products, cosmetics, tobacco products, veterinary products, alcohol, advertising, consumer products, meat and poultry, and drug abuse. Alternatively, the FDA serves the role of approving the various products it regulates to the market. The approval is based on the laws it makes and the relative risks of the specific products to the consumers' health. Furthermore, the FDA provides guidance information about the accepted products that resonate with its laws and regulations. The three functions are to ensure the protection of public health by promoting efficacy and security; therefore, the public is free to access information through the electric reading rooms.

Agency News

In a press release dated September 29, 2023, the FDA granted initial marketing authorization for a DNA test to assess the predisposition for various cancer types (United States Food and Drug Administration, 2023). The test was capable of evaluating multiple genes involved in a single test with next-generation sequencing. The action added more information concerning health, including certain cancer predispositions, and guided physicians in appropriate potential therapy and monitoring based on the discovered variants. The effort resulted in the emergence of a new regulation classification depicting that the subsequent same type of devices should pass through the FDA's 510 premarket processes. It influences the management personnel of the FDA, where the personnel dealing with the same type of devices or wanting approval must obtain authorization by demonstrating predicate device equivalence.

The United States Food and Drug Administration (2023) page depicts the announcement of two public meetings, including the Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting Systems (FAERS). The aim of the two conferences focuses on the pharmaceutical industry in providing updated information on the progress, plans, and technical specifications in upgrading electrical submission standards in the post market and premarket surveillance safety programs. The management of the standards involves the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). It, therefore, demonstrates the possibility of the meeting influencing FDA personnel to adhere to the post and premarket programs.

Rationale for Selecting the Agency

The organization's choice was triggered because the FDA deals mainly with the public health of individuals and society. By including the FDA laws and regulations, the health safety and security of the members of the public is promoted. It, therefore, gives insights into ways the FDA influences the products and services that human beings consume. Alternatively, focusing on the FDA helps in research and analysis where the decisions and the policies of FDA public health trends, regulatory outcomes and healthcare innovation. It is related to the essential role of the FDA in informing members of the public concerning health in case of pandemics such as Covid 19 (Vardhana, 2022). FDA performs a vital role in informing about strategies for public health. Following the FDA public notices and updates provides insights into improving outcomes as a researcher and healthcare practitioner.

References

United States Food and Drug Administration. (2023). About FDA. https://www.fda.gov/about-fda

United States Food and Drug Administration. (2023). Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards. https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using

United States Food and Drug Administration. (2023). FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types. https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types

Vardhana, S., Baldo, L., Morice, W. G., & Wherry, E. J. (2022). Understanding T-cell responses to COVID-19 is essential for informing public health strategies. Science immunology,  7(71), eabo1303. https://www.science.org/doi/full/10.1126/sciimmunol.abo1303

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