Regulatory Agency Paper Essay Sample

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The Food and Drug Administration (FDA) is one of the agencies of the United States Department of Health and Human Services. The FDA is tasked with protecting the public by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation (“FDA Fundamentals”, n.d.). The FDA consists of the Office of the Commissioner and four directorates that oversee the centered functions of the agency. The FDA’s core functions oversee medical products, tobacco, foods, global regulatory operations and policy and operations. The FDA reviews and oversees the production of prescription and over the counter drugs to ensure safety to the public. Medical devices are tested and data is reviewed to ensure the safeness of its use before approving the use in patients. The FDA regulates drugs that are used in health care and monitors and collects data regarding the possible risks associated with the use of certain drugs. The FDA can enforce the recall of a drug from being used or restrict its use to limited terms to avoid adverse reactions associated with long term use and the possibility of developing other ailments or symptoms that could be linked to the use of a specific drug.

For prescription drugs, the FDA approval process requires substantial evidence of efficacy and safety for specific clinical situations. The FDA provides data to clinicians on the possibility of adverse reactions when combining two or more drugs that are prescribed or over the counter (OTC). The use of the OTC drugs are regulated by the FDA on how they are sold and at what dose and may enforce pharmaceutical companies to label drugs with specifics of risks, dangers and possible adverse reactions. The recommended dosage is approved and recommended by the pharmaceuticals with FDA approval. Medical devices implanted in patients are regulated and data is kept by the pharmaceutical companies which are enforced by the FDA. The FDA clears most medical devices based on their substantial equivalence to other legally marketed devices (Hyman & Carvajal, 2009). Other methods that the FDA uses to approve devices are through scientific data and research provided by the inventor or pharmaceutical company.

The may be able to seek an expert medical review of certain data to ensure the provided data is accurate. Medical devices can be approved by following the guidelines that are set by the FDA. The FDA may request additional data that can be obtained by more in depth testing and trials. The FDA can impose a delay on the use of a medical device pending the results of long term use. Long term use is regulated and enforced by the FDA when scientific data is not clear on the effects of the use of a medical device. The impact that the FDA has on health includes the use and prescription of drugs, medical devices, and the use of products that give off radiation. The FDA monitors and collects data on the use of prescribed medications and depends on clinicians and the patients to provide valuable data on the use of certain drugs. In the past, drugs have been recalled due to public and clinician complaints about serious side effects in the use of the drug on its own or in combination with other prescribed medications.

More recently the FDA suspended a regulation where the manufactures would determine if the drug was safe to be used on pediatrics. The FDA made the ruling because most manufacturers did not conduct drug efficacy and safety studies in children, which left clinicians in limbo (Guharoy, R., 2002). The FDA’s decision was made because pharmaceutical companies failed to provide substantial clinical data that would determine the effectiveness and safety of use in children. Vaccines, blood, and biologics are regulated by FDA’s Center for Biologics Evaluation and Research (CBER). CBER protects and advances the public health by ensuring that these products are safe and effective and available to those who need those products (“FDA Fundamentals, n.d.). The use of blood products on patients and the methods in which blood products are collected, dispensed and used is regulated by the FDA. The FDA governs and regulates the testing and collection of blood for HIV/AIDS testing and other tests that involved blood collection, storing and transportation of blood specimens. The production of blood derived products such as plasma and albumin require approval from the FDA ensuring the collection, processing, storage, transportation and usage of blood products.

Research conducted involving the use of human blood must meet all requirements safeguarding the public from virus tainted blood products. The FDA is responsible for the safety of the public by ensuring that drugs have been tested sufficiently enough to ensure the public the it is safe to use or agree to the use of procedures to treat, cure and diagnose illness’s and diseases that a patient currently may suffer. Research and clinical data is collected and provided by the pharmaceutical companies and manufactures or medical devices and the method in which the FDA carries its duties is through regulation, law recommendation and enforcement of laws pertaining to the use of all drugs and devices that are utilized in health care. The responsibility of the FDA extends to OTC drugs and vitamins and retail food protection. The FDA ensures the safety of any FDA approved drug and will take action should the long term effects endanger human life. The FDA will investigate and review all scientific data pertaining to any health claim.

A health claim is any claim made on the label or in the labeling of a food, including dietary supplements, that expressly or by implication, including “third party” references, written statements (e.g., brand name including a term such as “heart”), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition [21 Code of Federal Regulation (CFR) 101.14] (Ellwood, Trumbo & Kavanaugh, 2010). The authority in relation to health care is aggressive in the process of approving any form of drug, medical device and retail food protection for the consumer. The directorates are tasked with regulating specific elements of the agencies structure. The duties and responsibilities of the FDA resonate through the use of drugs, the use of medical devices, and the use of devices of equipment that produce radiation. The process in which the FDA certifies or issues an FDA approval depends on the specifics of what seeks approval and what type of studies, research and tests have been conducted to provide supportive data that will ensure its effectiveness and safety.

The FDA provides a guideline on what steps are needed to take in order to receive an FDA approval such as performing tests on laboratory animals with safe results before testing on humans. The FDA would monitor a clinical test on humans that is conducted in three levels to test the products effectiveness and safety. The product is then sent a team of specialist (physicians, toxicologist, scientists, and chemist) to review the test data and recommend based on benefit outweighing risks. When the product is approved for use and sale, the FDA continues to monitor the effectiveness of the product by using an adverse event reporting system. During the monitor if any minor risks are detected and confirmed additional warnings can be added to the label. The agency’s surveillance of drug-related problems, which had primarily focused on analyses of various adverse-event databases, is now expanding to more active uses of evolving computer technology and linking to other public and private information sources (Thaul, S., 2012).

Should the drug detect and confirm lethal events due to the use of the product, the FDA will issue an immediate communication to suppliers and users and order an immediate recall of the product. The FDA’s participation in health care is a critical and extensive one due to the use of drugs, blood, and use of medical devices and equipment that produces radiation. The extensive and rigorous level of testing involving animals and humans provides the FDA with a general idea of risk level associated with the product use. The FDA regulates the manufacturing of medical and radioactive products that are given or used by health care consumers for the promotion of healing, deterrence of illness and disease and the detection of failing health. The FDA’s impact in health care is huge because of the mandates, regulations and laws that are implemented and enforced by the agency to protect public health.


Ellwood, K., Trumbo, P., & Kavanaugh, C. (2010). How the US Food and Drug Administration evaluates the scientific evidence for health claims. Nutrition Reviews, 68(2), 114-121. doi:10.1111/j.1753-4887.2009.00267.x FDA Fundamentals. (n.d.). U S Food and Drug Administration Home Page. Retrieved from Guharoy, R. (2002). Drug safety and effectiveness in children. American Journal Of Health-System Pharmacy, 59(16), 1569. Hyman, P. M., & Carvajal, R. (2009). Drugs and other product choices. Dermatologic Therapy, 22(3), 216-224. doi:10.1111/j.1529-8019.2009.01234.x Stafford, R. (2008). Regulating off-label drug use–rethinking the role of the FDA. The New England Journal Of Medicine, 358(14), 1427-1429. Thaul, S. (2012). How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Congressional Research Service: Report, 1-19.

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