Regulatory Agencies and Accrediting Bodies – Week 2 Solution

This article discusses Regulatory Agencies and Accrediting Bodies in relation to community health.

Instructions

This assignment is designed to give you a greater understanding of regulatory agencies and accreditation bodies, including their functions, public reporting requirements, and the how they impact quality and safety.

Select and evaluate a regulatory agency or accrediting body.

Discuss the history of the agency or body.

Explain the reason for its existence.

Summarize the agency\’s public reporting of quality indicators:

  • Frequency
  • Where they are reported
  • Why public reporting of these metrics is important

Explain how the agency or body operates:

  • Current function
  • Organizational structure
  • Governance

Analyze the impact the agency or body has on quality at each level of health care: 

Citeat least two sources in an APA-formatted reference page.

Format your assignment as one of the following:

  • 875-word paper

Solution

Regulatory Agencies and Accrediting Bodies

For this paper, I will discuss the USA Food and Drug Administration (FDA), a federal agency within the Department of Health and Human Services (DHHS).

History

The FDA was established in 1906 following the Pure Food and Drugs Act legislation (FDA, 2018-a). Harvey Washington Wiley is credited for driving the establishment of the legislation. As the principal chemist at the USDA Bureau of Chemistry, Harvey headed the enforcement of the FDA legislation. Over the years, the FDA has undergone socioeconomic, political, and legal changes, indicating its evolving role in promoting public health and providing a framework for evaluating contemporary regulatory challenges. 

Reason for Existence

The primary function of the modern FDA was to illegalize the trade of adulterated and improperly branded drugs and food substances (FDA, 2018-a). However, the agency’s responsibility has grown to include regulating the production, advertising, and distribution of various substances such as tobacco, food substances and guide innovations of effective, safe, and affordable production of medical products (FDA, 2018-b). Equally, the FDA provides deliberate, accurate, and scientific information to guide public consumptions of medical products and food to prevent emerging public health threats.

The FDA’s Public Reporting of Quality Indicators

In January 2018, the FDA received quality metrics in line with its guidelines and published them in the Federal Register. The quality metric reporting is voluntary for drug and food manufactures. Quality metric reporting assists the FDA in developing compliance and audit policies and procedures and informing hazard planning for drug manufacturing operations (FDA, 2020-b).

The FDA’s Drug Safety-related Labeling Changes (SrLC) database includes updates to safety information in the labeling for human prescription drugs regulated under New Drug Applications and human prescription biological products regulated under Biologics License Applications. Moreover, the FDA publishes the Food Code every four years (FDA, 2019), while the National Drug Code Directory numbers are updated daily (FDA, 2020-a). Therefore, the FDA must publicize quality metrics to monitor quality control processes and systems of the biologics and drug manufacturing industries.

FDA Operations

The FDA’s duty is to protect the American Citizen’s health by regulating the safety and efficiency of medical and biological products and devices. The agency ensures the safety of citizens by regulating the supply of food, cosmetics, and radioactive electronic products (FDA, 2018-b). Other products regulated by the FDA include vaccines, tobacco products, and diet supplements (FDA, 2020-c).

The FDA is made up of the Commissioner’s Office and four directorates that oversee the agency’s functional areas, namely Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations (FDA, 2020-d). Besides, the agency has nine central-level institutions and 13 headquarters (HQ) Offices. The commissioner is the central authority within the FDA and is termly appointed by the president.

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Regulatory agencies and accrediting bodies
Regulatory Agencies and Accrediting Bodies

Moreover, the Senate provides the president with the advice and consent of the ultimately chosen commissioner. The commissioner works under and reports to the secretary of DHHS. Several statutory provisions passed by the United States Congress and construed by the agency per the Federal Food, Drug, and Cosmetic Act govern the FDA’s operations.

Impact of FDA on Healthcare

The FDA institution affects the healthcare system in various ways. For example, the FDA databases contain data that assist healthcare organizations in making various healthcare-related decisions, such as medical prescriptions and the use of medical devices (FDA, 2021).

The FDA invests in the appropriate collaborative partnerships with hospitals to educate them on its quality metrics requirements, i.e., for Medical Device Reporting (MDR) requirements to improve hospitals’ reporting of the associated adverse events and promote the safe use of the medical devices (Barlas, 2017). The FDA works with other health organizations to advance public health by supporting and streamlining the development and evaluation of new drug products.

While FDA does not regulate nursing practice, the agency FDA offers surveillance of medical devices and products’ continuing efficacy and safety, allowing nurses to report adverse events (FDA, 2021). Equally, the FDA is involved in the assessment safety and effectiveness of new medical technology and food ingredients. The FDA also builds opportunities to harmonize existing knowledge, databases, and standards.

In terms of patient care, The FDA’s Center for Drug Evaluation and Research (CDER) guarantees the safety and efficacy of drugs that are available used by the USA population to improve their health (FDA, 2021). Moreover, the FDA provides guidelines for the use of drugs and medical devices without professional assistance.

However, the agency influences how individuals can use medical devices safely and effectively. In this regard, the FDA contributes to health care for both hospitalized and home-based patients. The FDA conducts surveillance of approved and regulated medical products to ensure the safety of patients. The FDA promotes the availability of novel medical therapies for the US population. Therefore, the FDA protects patients from potential harm through these initiatives. Equally, the FDA is a significant agency fronting safe and quality public health practices and services.

References

Barlas, S. (2017). FDA flags inconsistent hospital reporting of medical device problems: hazy reporting rules beget confusion. Pharmacy and Therapeutics42(2), 97. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5265235/

The US Food and Drug Administration. (March 2018-a). FDA History. Retrieved 14 July 2021, from https://www.fda.gov/about-fda/what-we-do

The US Food and Drug Administration. (March 2018-b). What We Do. Retrieved 14 July 2021, from https://www.fda.gov/about-fda/what-we-do

The U. S. Food and Drug Administration (December 2019). FDA Food Code. Retrieved 14 July 2021, from https://www.fda.gov/food/retail-food-protection/fda-food-code

The U. S. Food and Drug Administration (January 2020-b). Quality Metrics for Drug Manufacturing. Retrieved 14 July 2021, from https://www.fda.gov/drugs/pharmaceutical-quality-resources/quality-metrics-drug-manufacturing

The U. S. Food and Drug Administration (December 2020-a). National Drug Code Directory. Retrieved 14 July 2021, from https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory

The U. S. Food and Drug Administration (December 2020-c). Regulated Products. Retrieved 14 July 2021, from https://www.fda.gov/industry/import-basics/regulated-products

The U. S. Food and Drug Administration (December 2020-d) (January 2020-d). FDA Organization Chart. Retrieved 14 July 2021, from https://www.fda.gov/about-fda/fda-organization/fda-organization-charts

The US Food and Drug Administration. (2021). Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS).  Retrieved 14 July 2021, from https://www.fda.gov/media/145001/download

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Regards,

Cathy, CS.