The Food and Drug Administration is one of the oldest regulatory agencies in the USA. Its history can be traced back to the 1840s when the government started placing emphasis on consumer protection (FDA, n.d.). At that time, the government started analyzing the chemical content of agricultural products to ensure they were safe. These functions were on transferred from the Department of Agriculture to the FDA later in the 20 th Century (FDA, n.d.). The FDA’s regulatory duties started in 1906 with the enactment of the Pure Food and Drug Act. The Act forbade misbranding and adulteration of food products. The Bureau of Chemistry in the Department of Agriculture was given the duty of examining food products for compliance with the Pure Food and Drug Act (FDA n.d.). In 1927, the regulatory duties were transferred to another body known as the Food, Drug, and Insecticide association, which was later changed to the Food and Drug Administration (FDA) in 1930.
After 1930, the FDA was given more regulatory powers by a string of legislation and reforms. In the 1950s, the Pure Food and Drug Act was amended to give the FDA more powers to recall ineffective drugs from the market (Temple, 2002) . In 1962, the act was changed again, giving the FDA extensive powers to conduct pre-marketing safety tests on drugs before approving them (Temple, 2002) . By 2017, the FDA was regulating roughly $1 trillion worth of consumer goods every year. These include foods, drugs, and electronic products such as microwaves and medical equipment. It regulates the products by coming up quality metrics, conducting inspections to ensure compliance, and conducting research on emerging technologies and challenges.
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The senior-most office in the FDA is that of the Commissioner of Food and Drugs (FDA, n.d.a). The President appoints the commissioner with Senate’s approval. The Commissioner of Food and Drugs reports to the Secretary of Health and Human Services. Below the Office of the Commissioner, there are more than ten departments, each specializing in a different field. The main departments include the Center for Biologics Evaluation and Research (CBER), Center for Food Safety and Applied Nutrition (CFSAN), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM), and the National Center for Toxicological Research (NCTR). Each center is led by a director who reports directly to the Commissioner of Food and Drugs (FDA, n.d.a). Today, the FDA has more than 50 field offices throughout all states. It also sends employees to foreign countries such as China and India which export food and drugs to the United States.
Quality indicators are essential tools in regulation; they are standardized measures that can be used to track performance or compliance with particular rules. The FDA makes use of quality metrics such as product quality compliant rate, lot acceptance rate, right first time rate, and annual product review on-time rate to ensure compliance with its set standards. (Land, 2015) Manufacturers collect quality metrics data and send it to the FDA through an electronic portal. The FDA then analyzes the data and uses it to plan risk-based inspections. Before coming up with quality metrics, The FDA collects views from different manufacturers and trade unions (Land, 2015) . It then publishes the finding and resolutions in federal register notices. The FDA also has online platform on which researchers, statisticians, and the general public can access different quality metrics reports and datasets. The FDA does not publish the quality metrics scores of specific manufacturers for the public perusal; it has an online portal where manufacturers can access the data confidentially. However, The FDA computes the average industry score annually, which it reports to the public.
Mainly, the regulatory role of the FDA entails pre-market review of new medical equipment, and food and drug ingredients; inspection of facilities and products to ensure compliance with regulations; and post-marketing review of FDA-regulated products to ensure patient and consumer safety (Throckmorton, 2017) . Through those initiatives, The FDA has improved the quality at different levels of health care. At the healthcare organization’s level, the FDA has improved quality by ensuring the safety and effectiveness of medical equipment. Manufacturers must register their medical devices with the FDA to be allowed to sell in the US. That includes providing details on the features of the medical equipment and how it works. The manufacturers are then required to provide scientific evidence that the device is safe and efficient; the FDA reviews this evidence before allowing the manufacturer to commence marketing activities. With this, healthcare organizations are assured that they are spending their money on medical equipment that works; the FDA protects healthcare organizations from rogue manufacturers.
Further, through research and regulation of drugs, the FDA has improved the quality of nursing practice. Nursing encompasses a wide range of fields in healthcare; from illness prevention to patient care. One of the main problems in the nursing field is lack of enough data to support decisions that nurses, doctors, and researchers make (Throckmorton, 2017) . The FDA is reducing that problem by doing research, and availing the raw datasets and findings to clinicians and their practice organizations. Also, by assuring the safety and effectiveness of drugs and medical devices, the FDA has improved the nursing sector.
Finally, the ultimate aim of the regulatory measures instituted by the FDA is consumer protection, and in the healthcare context, the patient is the consumer. By filtering out unsafe and ineffective medical devices and drugs, the FDA improves the quality of patient care. There have been several high-profile cases in the past where the FDA recalled or blocked the use of drugs that were later proven unsafe. In 1959, The FDA blocked the distribution of Thalidomide in the US market; it was later revealed that the drug had caused congenital disabilities in Europe where it was approved (Science Museum, n.d.). That demonstrates the role of the FDA as a patient protector.
References
FDA. (n.d.a). FDA Organization Charts. Retrieved August 20, 2019, from FDA: https://www.fda.gov/about-fda/fda-organization-charts/fda-overview-text-version
FDA. (n.d.b). The History of FDA's Fight for Consumer Protection and Public Health. Retrieved August 20, 2019, from FDA: https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and-public-health
Land, M. (2015, February 17). FDA’s Quality Metrics Initiative – From Compliance to Performance. Retrieved August 20, 2019, from American Association of Homeopathic Pharmacists: https://www.theaahp.org/articles/fdas-quality-metrics-initiative-from-compliance-to-performance/
Science Museum. (n.d.). Thalidomide. Retrieved August 20, 2019, from Science Museum: http://broughttolife.sciencemuseum.org.uk/broughttolife/themes/controversies/thalidomide
Temple, R. (2002). Policy Developments in Regulatory Approval. Statistics in Medicine , 2939-2948.
Throckmorton, D. C. (2017, March 20). FDA. Retrieved August 20, 2019, from The Public Health Role of Drug Regulation in the US: https://www.fda.gov/files/about%20fda/published/The-Public-Health-Role-of-Drug-Regulation-in-the-US.pdf
