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Regulatory Agency Essay

The role and responsibility of the U. S. Food and Drug Administration (FDA), most importantly, is to uphold the laws dictated by the government concerning products that include drugs, medical products, food, and non-health related products and to protect and promote public health across the country. This essay focuses on several aspects of the FDA, from the role of the agency and its effect on health care in the United States, to the authority this agency carries in relation to health care.

There will also be an explanation of how the FDA carries out these responsibilities on a day-to-day basis. The FDA has held a strong presence in the realm of public health since 1848 when it began as a consumer protection agency (FDA, 2013). The FDA, formed after the 1906 Pure Food and Drug Act was put in place and inspired by the scientific work of Harvey Washington Wiley, who was the Chief Chemist at the U. S. Department of Agriculture. Wiley worked to eliminate the dangerous practices of marketing unregulated drugs and food products to consumers (FDA, 2013).

Since that time, the FDA has become a powerful force, monitoring and working to protect public health in the United States. FDA Role The FDA is an agency that works within the Department of Health and Human Services. The Office of the Commissioner takes the lead role with four other branches that manage other functions (FDA, 2013). The Office of the Commissioner takes “leadership of the agency’s scientific activities, communication, legislative liaison, policy and planning, women’s and minority health initiatives, agency operations, and toxicological research” (FDA, 2013).

The four groups that work under the Office of the Commissioner are the Office of Foods, the Office of Global Regulatory Operations and Policy, the Office of Medical Products and Tobacco, and the Office of Operations. The function of these five entities of the FDA is to protect and promote public health in the U. S. and to uphold the laws dictated by the government regarding public health. This is accomplished through close monitoring and testing of regulated products used by U. S. consumers.

These products consist of drugs, food, cosmetics, radiation-emitting products, vaccines and other biologics, veterinary drugs and products, and tobacco products (FDA, 2013). The FDA is also constantly looking for ways to advance public health by assisting other organizations to make medications safe and more effective (FDA, 2013). Not only does the FDA monitor the food supply coming into the U. S. to ensure its safety but also plays a role in counterterrorism efforts by developing products and medications to respond to a public health threat (FDA, 2013).

Issuing and enforcing warning labels for drugs and other products is another function in the role of the FDA. The labels serve to educate the public and medical professionals on the use and hazards of using a specific medication or product. However, these labels do not always have the desired effect. Impact on Health Care The efforts of the FDA throughout its history, has created a much safer consumer environment as it relates to food products, cosmetics, and other non-medical items.

Foods are carefully scrutinized before they are allowed on the market to ensure these products are safe for the public to consume. Strict guidelines are in place for all types of products that are available to consumers. However, there is some controversy concerning warning labels on prescription drugs. There have been recent reports that communications by the FDA regarding drug risks are not immediately effective (Hitt, 2012). It is the duty of the FDA to monitor and enforce warnings for prescription drugs involving the safety risks to public health.

According to Emma Hitt, some of the warnings that recommended increased monitoring of a patient while taking a prescription drug or increase laboratory monitoring generally caused a decrease in the use of the drug and very low increases in monitoring (Hitt, 2012). These types of oversights in clinical practice likely cause adverse effects to patients by not heeding the proper warnings set forth by the FDA. This is just a minute area in which the FDA impacts health care.

Just as the FDA is responsible for monitoring drugs, products, and foods, their communications to health care providers and consumers must also be taken seriously. As Hitt states, “as the goals of risk communication are to minimize potential harms, understanding the impact of an FDA communication’s intended (and unintended) consequences on patient health outcomes should be a priority” (Hitt, 2012). Duties of the FDA The FDA carries an enormous responsibility daily to monitor, investigate, and enforce the safety of the public in general.

As discussed earlier, this includes products and medications used by consumers daily. There are times when the regulations and guidelines set forth by the FDA on specific products are not followed and thus the FDA must follow up with inspections, enforce compliance, and conduct criminal investigations (FDA, 2013). The Office of Regulatory Affairs (ORA) is the lead office in this function of the FDA. It is the duty of the ORA to carry out investigations if a breach in regulation is suspected.

Once a questionable observation is made by an investigator of the ORA, a form entitled “Form 483” is filled out by the investigator (FDA, 2013). On this form, the investigator cites what the law or regulation is and proceeds to list the questionable conditions and what law or regulation is violated. These 483 forms are maintained and revisited periodically. Some of the areas investigated are biologics, drugs, human tissue for transplantation, foods, and radiological health, to name a few. This is a major function of the FDA to ensure compliance to laws and regulations. Regulatory Authority

The FDA has regulatory authority provided in the “Federal Food, Drug, and Cosmetic Act” (FD&C) passed by Congress in 1983. The creation of this legislation was driven by an incident where more than 100 patients died due to improperly prepared sulfanilamide medications. It replaced the earlier Pure Food and Drug Act of 1906 (FDA, 2013). The agency has authority to mandate preventative actions for food facilities to ensure food safety. They also have the power to conduct compliance inspections on facilities the scope of which include access to records and testing by accredited laboratories.

The FDA also has several responses it can take to enforce compliance and ensure safety of consumers. It can enforce a mandatory recall of a product, and it can suspend the registration of a facility if it is determined to pose a threat of serious health consequences or the threat of death to humans or animals (FDA, 2013). Accreditation, Certification, and Authorization The FDA’s Center for Drug Evaluation and Research is the division of the agency charged with the evaluation and approval of any drug prior to its release on the market.

There are three phases in this certification and approval process. The research phase is conducted during the manufacture of a drug, along with the testing, then sent to a review board for recommendation (Writing, 2013). Once the recommendation is given, the drug can move to the second phase, the pre-clinical trials. Here the drug is tested on small groups of humans while measuring interactions and its effectiveness. Once this phase is complete with no adverse issues, the third phase can take place.

This is a Phase 2 clinical trial that allows researchers to see if the drug works on a specific illness on patients and allows scientists to determine any side effects that may occur (Writing, 2013). The clinical phases are monitored closely, while working directly with patients to ensure that the testing remain within the standards of medical ethics. Once all of the trials are complete and all recommendations have been given, all of the results are analyzed and only then can be submitted to the FDA for approval to be sold on the market (Writing, 2013).

The accreditation and approval process for all products that must be in compliance with FDA guidelines is a rigorous process but necessary for the common good. Conclusion The FDA carries so many responsibilities to provide high quality medications, foods, cosmetics, and many other products. The laws and regulations are complex and detailed. So much, in fact, most people are not aware when a regulation or guideline is being violated. The resources available to research the FDA and their functions and laws are many and well worth the time to gain education on how this enormous entity works to protect and promote public health and safety.


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