A regulatory agency is a governmental entity that is established by the legislature to implement and execute certain laws. Regulatory agencies are essential since they promote, safeguard and track the health and safety of the public by ensuring appropriate standards of practice in certain fields. One of the regulatory agencies in the United States is the Food and Drug Administration (FDA). It is a federal agency in the department of health and human services and is tasked with the responsibility of safeguarding and enhancing public health by establishing standards and tracking of tobacco, food safety, vaccines, dietary supplements, biopharmaceuticals, medical devices, blood transfusion, cosmetics, electromagnetic radiation, veterinary products, emitting devices, animal feeds, food, prescription and over the counter medication.
The History of the Food, Drug and Administration (FDA)
The agency’s history can be traced to 1906 with the passing of the Federal Food and Drugs Act. Between 1879 and 1906 there were efforts to implement laws regarding the regulation of locally produced foods and drugs. Between 1879 and 1906 there were more than 100 legislative bills considered for implementation. President Theodore Roosevelt eventually signed the Food and Drugs Act on June 30, 1906. The Bureau of Chemistry was tasked with administering, and restricting the adulteration or misbranding of drugs and food. After Wiley left the bureau in 1912, they committed to the regulation of drugs with more focus on patent medications. Misbranding was one of the main controversies in the management of drugs. The act of 1906 has many shortcomings which led to poor execution; however, President Franklin Delano Roosevelt signed the Food, Drug and Cosmetics Act on June 25, 1938 (Lawrence et al. 2016). The law mandated that the agency would pre-approve all new drugs before they were released in the market; the agency still operates under the premise today although it has been amended severally.
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The Agency’s Reason for Existence
The agency was set up to safeguard and promote public health through establishing standards for the production and utilization for food and drugs produced locally or imported into the country. The agency was set up as a result of a congressional act (Lawrence et al. 2016).
The Agency’s Public Reporting of Quality Indicators
Frequency.
The new FDA Quality Metrics Initiative commenced in April, 2013 and promotes pharmaceutical firms to embrace regular improvement and foster a culture of quality by establishing and reporting manufacturing quality data (Lawrence & Woodcock, 2015 p. 2). Pharmaceutical companies are required to submit metrics data by site or product on a quarterly basis.
Where it is reported.
The FDA commenced the use of an online electronic portal in January 2018 for the submissions of quality metrics data on a quarterly basis.
The importance of public reporting of quality metrics.
The reporting of quality metrics is important since it aids the FDA to establish compliance and inspection practices and informs risk-based scheduling of drug manufacturing facilities which can consequently cause the reduction in inspection for better performers (Parekh et al. 2015 p. 221). Additionally reporting quality metrics will help the FDA assesment of drug manufacturing and control operations. The process also helps determine situations that may risk drug supply.
Agency’s Operation
Current Operation.
The Functions of the FDA include encouraging health by reviewing research and allowing new products in the market. The second function of the FDA is to ensure that drugs and foods are labelled appropriately. The third function of the regulatory body is to collaborate with professionals in the scientific field and consumers to effectively perform their duties. The fourth functions to cooperate with other countries with the intention to limit the burden of regulation.
Organizational Structure.
The FDA organization involves the Office of the Commissioner and four distinct directorates undertaking the main roles of the agency. The Office of the Commissioner is involved with the agency’s legislative collaboration, policy and planning, communication, scientific activities, and toxicological research. The Immediate Office of the Commissioner and National Center for Toxicological Research are under the Office of the Commissioner. One of the four directorates is the Office of Foods and Veterinary Medicine; the office is concerned with leading the FDA food program that highlights food safety, nutrition and other main areas to attain public health objectives. The second directorate is the Office for Global Regulatory Operations and Policy which gives leadership for FDA’s local and imported products quality and safety. The third directorate is the Office of Medical Products and Tobacco which gives advice to the commissioner on all medical products and tobacco related issues. The Office of Operations, the fourth directorate gives agency.
Governance.
The commissioner is the head of the agency and provides directives to support the efficient administration and the agency’s consumer protection efforts. The commissioner is appointed by the president with the counsel and permission of Senate. The commissioner often liaisons with the legislature. The agency is regulated by several statutes executed by the United States Congress. The agency’s budget is provided by pharmaceutical companies through the Prescription Drug User Fee Act. The FDA advisory committee provides independent counsel to the agency however the FDA makes the final decisions. The advisory committee includes a chairperson, members, a representative of the consumers, patients and industry (Lawrence et al. 2016).
Impact of the Agency on Each Level of Healthcare
Healthcare Organization.
The FDA is involved with regulating prescription medication, over-the-counter medication, medical devices, vaccines, biopharmaceuticals and blood transfusion. The quality and efficiency of the medications released to the market can either improve or deteriorate the quality of care at healthcare institutions. The FDA collaborates with professionals in the healthcare industry to educate staff at healthcare institutions on the safe use of medical devices (Lawrence & Woodcock, 2015 p. 2). The agency also regulates the quality of medical devices; high quality devices improve the quality of care at a healthcare institution.
Nursing Practice
The agency has helped improve the quality of care in the nursing practice through regulation of drugs. The medical devices regulated by the FDA have helped improve nursing practice by making it easier for patients to deliver quality care. The regulatory practices of the FDA has enhanced patient safety and restricted clinical risks hence improving the quality of care provided by nurses.
Patient Care
The FDA is often perceived as the advocate for patients since they ensure that they receive the best care through regulation of drugs and medical devices. Increased product quality is beneficial since it establishes confidence that the medical devices will perform as intended. With the absence of the FDA, the level of patient care would deteriorate since pharmaceutical companies could release poor quality medication with the main intention of making money rather than protecting the interests of patients.
Conclusion
The Food, Drug and Administration is a regulatory agency in the United States tasked with the responsibility of safeguarding and enhancing public health through creating standards and supervision of tobacco, food safety, vaccines, dietary supplements, biopharmaceuticals, medical devices, blood transfusion, cosmetics, electromagnetic radiation, veterinary products, emitting devices, animal feeds, food, prescription and over the counter medication. The agency was set up after the passing of the Food, Drug and Cosmetics Act on June 25, 1938. Although the law has been amended severally over the past years, the premise of regulation still remains the same. The FDA Quality Metrics Initiative requires that pharmaceutical companies report their quality metrics to an online portal on a quarterly basis. The FDA organization structure involves the Office of the Commissioner and four distinct directorates undertaking the key roles of the agency. The FDA quality initiatives are beneficial for all stakeholders since they improve the quality of care at an organizational, professional and patient level.
References
Lawrence, X. Y., & Woodcock, J. (2015). FDA pharmaceutical quality oversight. International journal of pharmaceutics , 491 (1-2), 2-7.
Lawrence, X. Y., Akseli, I., Allen, B., Amidon, G., Bizjak, T. G., Boam, A., & Furness, S. (2016). Advancing product quality: a summary of the second FDA/PQRI conference.
Parekh, A., Buckman ‐ Garner, S., McCune, S., ONeill, R., Geanacopoulos, M., Amur, S., & Woodcock, J. (2015). Catalyzing the critical path initiative: FDA's progress in drug development activities. Clinical Pharmacology & Therapeutics , 97 (3), 221-233.
