Food and Drug Administration – Regulatory Agency

Among the existing variety of regulatory agencies and accrediting bodies, the role of the Food and Drug Administration (FDA) remains integral and indispensable. Healthcare organizations, nurses, and even patients may address it for help and evaluation. The medical marketplace continues developing, and the task of the FDA is to obtain proofs of clinical decisions, disease outcomes, and other care aspects. This paper focuses on an understanding of the FDA’s history, functions, reports, and impacts at different healthcare levels to prove the worth of this regulatory agency in care processes.

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Agency History

Officially, the FDA was formed at the beginning of the 1900s. However, the history of its fight for consumer protection began in the 19th century when it was necessary to control the safety of agricultural products (U.S. Food & Drug Administration 2018a). In 1906, the Pure Food and Drugs Act came into force and prohibited the use and distribution of misbranded food and drugs (.S. Food & Drug Administration 2018a). It was one of the first steps taken to demonstrate that the government was ready to take care of its people and consider the quality of offered products and services.

Reasons for Existence

In addition to the necessity to protect public health, the FDA is now responsible for ensuring the safety and security of all drugs, biological products, and equipment that can be available to people in healthcare facilities. The reasons for its existence also include the control of tobacco manufacturing and marketing, the evaluation of innovations and their impact on medicine, and the promotion of food supply security. Today, FDA’s approval becomes a crucial standard, proving that the risks of a product/item/service are not as significant as possible benefits.

Public Reporting of Quality Indicators

Frequency

There are no special deadlines for FDA managers to complete their reports because of the number of investigations and companies chosen for analysis. According to the data presented in the registration database, the FDA chooses manufacturers and devices and sets the priorities for their inspections in regards to risks and complaints if any. In addition, the FDA introduces annual reports regularly to demonstrate the scope of the work and findings.

Places of Reporting

More than 10,000 employees work at FDA. Its offices are located throughout the United States with its main headquarter in White Oak, Maryland. The results of investigations and information about different medical devices and products can be found at this office or on its official website www.fda.gov. A specially developed FDA adverse event report system (FAERS) dashboard helps stakeholders track recent reports on specific drugs or products. This system allows any person to report on a problem and waiting for FDA’s response. Inspectional findings are also delivered to the facilities where these inspections occur in the form of a narrative establishment inspection report.

Importance of Reporting

Several explanations for why FDA reports are necessary for the US population can be given. People are exposed to multiple new products and services the quality and safety of which are hard to check. FDA’s approval is a sign of high quality and trust, and many companies take all possible steps to obtain it. It is not easy to gather information about innovations regularly. FDA reports help to have a look at the recent discoveries and realize which ones deserve attention and recognition. Finally, all reports contain the results of the investigations based on the Quality System Inspection Technique (QSIT). The safety and effectiveness of innovations must be proved, and the FDA system has never failed.

Operations

Current Function

The current mission of the FDA is to protect public health and ensure the safety of medical products and devices. Its functions also cover the control of food supply, cosmetics, and tobacco consumption. People have access to different services and ideas, and their safety is a function that the FDA has been completed during the last 100 years.

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Organizational Structure

Nine main centers and officers introduce the core of the FDA. The Office of the Commissioner is the main body that leads such parts as the Office of Operations, Foods and Veterinary Medicine, Drug Evaluation and Research, etc. Each facility has its goals and responsibilities and evaluates human needs and available resources.

Governance

The FDA is a federal agency that is empowered by the US Congress to create special acts, regulations, and programs related to food and drug safety and its promotion to society. The head of the Office of the Commissioner is appointed by the President and has to report to the Secretary of Health and Human Services. At this moment, this position is taken by Scott Gottlieb.

FDA Impact on Health Care

Healthcare Organizations

Healthcare organizations benefit from FDA reports and learn the latest innovations in medicine and patient care. Administrators learn how to keep their systems safe from outside threats. The promotion of safe use of medical devices is the lesson facilities receive from FDA regularly.

Nursing Practice

Nurses learn about the standards of care and patient education through FDA guidelines. FDA controls the work of all medical workers and promotes equality of services and professional relationships. Nursing practice has been considerably improved with FDA’s requirements and assessments.

Patient Care

Patient engagement in care was approved by the FDA several decades ago. Now, the patient perspective helps to evaluate the effects of therapies and diseases and improve healthcare outcomes (U.S. Food & Drug Administration, 2018b). Patients learn how to speak about their health problems and receive the services they deserve and need.

Conclusion

In general, the work of the FDA cannot be ignored by modern healthcare facilities. This agency has already survived numerous social, economic, medical, and political changes and stayed loyal to its main idea of public health protection. People should not suffer from new medical devices, drugs, and products, and the FDA is ready to give its approval to any organization whose risks decrease the number of their benefits. This agency has its impact on healthcare organizations, nurses, and patients, and their reports introduce a general picture of available resources.

References

U.S. Food & Drug Administration. (2018a). The history of FDA’s fight for consumer protection and public health. Web.

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U.S. Food & Drug Administration. (2018b). Learn about FDA patient engagement. Web.

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StudyCorgi. (2021, July 1). Food and Drug Administration – Regulatory Agency. Retrieved from https://studycorgi.com/food-and-drug-administration-regulatory-agency/

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"Food and Drug Administration – Regulatory Agency." StudyCorgi, 1 July 2021, studycorgi.com/food-and-drug-administration-regulatory-agency/.

1. StudyCorgi. "Food and Drug Administration – Regulatory Agency." July 1, 2021. https://studycorgi.com/food-and-drug-administration-regulatory-agency/.


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StudyCorgi. "Food and Drug Administration – Regulatory Agency." July 1, 2021. https://studycorgi.com/food-and-drug-administration-regulatory-agency/.

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StudyCorgi. 2021. "Food and Drug Administration – Regulatory Agency." July 1, 2021. https://studycorgi.com/food-and-drug-administration-regulatory-agency/.

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StudyCorgi. (2021) 'Food and Drug Administration – Regulatory Agency'. 1 July.

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