The FDA's Role in the Healthcare Industry

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The Food and Drug Administration is an agency of the Department of Health and Human Services regulating pharmaceuticals. The Food, Drugs, and Cosmetics (FD&C) Act and the Public Health Service Act define the agency's mission. The FDA's responsibilities and authority apply to all 50 states and the US territories and possessions. Furthermore, the FDA oversees a diverse range of products, including drugs, foods, biologics, cosmetics, veterinary products, tobacco products, and medical devices. Nonetheless, the regulatory agency's primary responsibility is to supervise the healthcare sector. The key responsibility of the agency is to oversee the safety as well as the effectiveness of the medical drugs that are marketed in the United States. FDA divides its roles and responsibilities into two phases, which are the premarket approval and the post-market approval. The agency has the role of reviewing the manufacturer’s applications to market their medical drugs, devices in the country. This means that drugs cannot be vended in the United States devoid of the endorsement by the FDA. The continued regulation of the drug safety and efficiency continues with the proviso that the medical product is still on the market. This is done through tracking, supervision and the reporting of the studies, and effectiveness of the drugs and other medical products used by the public. Furthermore, the agency seeks to promote product integrity in the healthcare industry in addition to regulating the advertisement of the medical products and the regulation of tobacco use. Equally important is that the agency disseminates information regarding drug safety and effectiveness to the clinicians and the general public alike.

The Role of the FDA in the Healthcare Industry

The Food and Drug Administration (FDA) as an overseeing agency is operating within the U.S Department of Health and Human Services. The undertaking of the agency as specified in the Food, Drug, and Cosmetic (FD&C) Act is to endorse the well-being of the public by punctually and proficiently reviewing drugs, medical devices and biologics as well as enforcing apt measures in the promotion of regulated products in an opportune manner (Gulfo, Briggeman & Roberts, 2016). Besides, the FDA also implements other regulations, particularly Section 361 of the Public Health Service Act and other concomitant rules, many of which are not unswervingly connected to drugs and food. For the reason that the FDA regulates a wide variety of products, it is broken into the Office of the Commissioner and four other directorates which are Office of Food and Veterinary Medicine, Global Regulatory Operations and Policy, Medical Products and Tobacco and the Office of Operations. Whereas it’s regulatory mandate covers all the 50 States, FDA’s responsibilities extends to the District of Columbia and American Samoa among other U.S belongings and territories.

The FDA plays a crucial part in the protection of the public well-being as well as in the minimization of the risk involved in the distribution of ineffective and unsafe medicine in the United States (Spears, Francer & Turner, 2015). Conceivably, equally significant for the health industry is the concern for the medical specialists to be well acquainted regarding the convenience and hazards of the drugs they recommend. This means that the sharing of information is vital to health care delivery just as is the importance of the medical treatments and approval of medicines. This underlines the importance of the FDA as a regulatory body in the United States. Although the agency’s scope is very wide, it is closely connected to those of other government agencies in a bid to oversee the safety of cosmetics, drugs, food, and medical devices among other health connected clinical products. Considering the agency is the controlling authority of about 25 percent of the country’s economy, it is important to understand the roles and responsibilities of the Food and Drug Administration that fall under its regulatory framework in the healthcare industry.

Roles of the FDA

The quality, cost as well as access are three extents of the healthcare system that the FDA regulates. That is to say, the agency regulates medical products thereby impacting on these measures. Faris & Shuren (2017) notes that medical products account for a larger proportion of more than 15% of the health costs. FDA’s evaluation of the products ensures their effectiveness as a major constituent of the health care quality. Besides the agency facilitates the availability of the medical products to consumers to enhance the access to the healthcare services. Still, in healthcare perspective, it is worth noting that the regulatory requirements of the agency upsurge the quality of medical products reaching the market. The regulatory agency may also raise the cost of the medical products or delay the access of the consumers to them. Put differently, the FDA has the power to influence the health care system through its direct regulation of the medical products.

The FDA works closely with other federal government agencies to facilitate a comprehensive management of the medical devices, counter cyber security threats, ensure continuous improvement of medical devices and incentivizes varying marketed and distributed medical devices to lessen their risks (Faris & Shuren, 2017). Medical devices are very critical in people’s health worldwide. Starting with an everyday household like thermometers to multifaceted implantable like deep-brain stimulators, the public relies on the agency to facilitate the legal marketing of the medical devices and ensure they are safe and effective. The FDA ensures that the data provided by the medical device manufacturers reflects the risk profile of the devices. Moreover, the FDA recognizes that even though medical devices are becoming digitally interconnected and interoperable and can improve the care of patients and efficiencies in the health care system, they can as well be vulnerable to security breaches. For this reason, the FDA has the duty to encourage the medical device manufacturers to address the cyber security threats to ensure the safety of patients and better protect the public health. In addition, the agency continues to ensure the effectiveness and safety of all the medical devices at all the phases of the life cycle, in the face of potential cyber threats.

The Food and Drugs Administration has the duty to provide premarket approval for all medicinal devices, drugs and biological products that are to be marketed in the United States. The agency gathers evidence to ensure the safety together with the effectiveness of the medical supplies. The FDA’s market pre approvals are designed to issue an initial permission decision. Besides, the premarket approvals rely on the type of the medical supplies since a majority of the processes are based on the evidence provided by the clinical trials.

Equally important is the need for post-market regulation. The FDA is also responsible for the safety and effectiveness of the medical products it regulates including food, once they are on the market. The agency facilitates this by tracking the products, inspecting them and through enforcement (Madden, 2009). Also, the agency has different enforcement authorities for diverse product types. For instance, the FDA has a compulsory recall authority for the infant formula and medical products which do not apply to the prescription of drugs and other foods. Therefore, the post market controls enforced by the FDA seek to modify the drug labels or even to withdraw drugs that have issues in their use in the marketplace. Also, it is worth noting that the role of the regulating globalized markets, inspection, and importation of medical products is the responsibility of the FDA. Matters related to the inspection and importation encompass a vital element to the post market-activities of the agency.

The FDA has the role of regulating the advertising of prescription drugs, which is one of its important function. Even though the Federal Trade Commission is obligated to oversee the advertising of nonprescription drugs, the FDA regulates the product labeling that the adverts the nonprescription drugs should reflect (Fang et al., 2016). The agency requires that television adverts be submitted for review before they can be disseminated. The decision on whether the advert can be aired depends on the review where the impact of the drug on particular population groups is considered. Such information concerns the information regarding the seriousness of the risks listed in the drug’s labeling as well as the date that the drug was approved.

After the medical devices, drugs and other biologics have been approved, the FDA continues to monitor its safety. The agency requires the manufacturers of such products to report all serious and unexpected adverse reactions within a fortnight of becoming aware of the danger. They should also report the outcome of the medical research they conduct on its approved products. Consumers, patients, and health professionals can also report the adverse reaction to the agency through the FDA’s MedWatch reporting system at any time (Day, 2009). Besides, the FDA has the duty to gather information concerning probable adverse reactions to the products that have been approved to be used in the United States. The agency has provided procedure upon which physicians and the consumers can express their concerns about drugs and adverse events.

While the safeguarding of medical product integrity was a significant charge of the FDA’s forerunners, it remains to be a vital concern of the agency. Basically, the agency directs its expectations and stipulation that every manufacturer and stakeholder of the marketplace must meet (Spears, Francer & Turner, 2015). This allows the agency to oversee the manufacturer’s facilities, transportation, and warehouse plan to make certain that safety and effectiveness of the products are prioritized. The tracking of product integrity is enforced by the chain-of-custody document provided by the FDA to record the movement of drugs from the manufacturing point through the supply chain to the final dispenser.

In due course, the FDA’s undertaking is to offer clinicians in the medicinal market place with the access to effectual as well as safe drugs, medical devices, and biologics in not just efficient but prompt and well-timed manner. The healthcare marketplace, which entails physicians, patients, and buyers, operates to ascertain the finest products for every patient (Gulfo, Briggeman & Roberts, 2016). In particular, the agency has enforced restrictive policies with regard to new drugs in the medical marketplace in efforts to anticipate the medical results of the medical treatment. In addition, FDA has an explicit purpose of determining if a drug is satisfactorily effective by evaluating the drug’s pharmacological effects on an illness in addition to anticipating its clinical utility. It is only after the FDA has permitted the use of medical drugs, devices, and biologics that the medical marketplace can adopt the best treatment from those approved. This means the agency is at the top of the funnel when it comes to ensuring the safety and effectiveness of medical products at the marketplace.

Concerning drugs, the FDA’s role is a lot more complicated. In most instances, the agency requires that the manufacturers who strive to sell their drugs in the U.S. either over the counter or through prescription should substantiate the safety and effectiveness of the products. The prescription and over the counter drugs, which includes the generic drugs are controlled by one of the FDA’s divisions called the Center for Drug Evaluation and Research (CDER). Besides, the division regulates more than just drugs, for instance, notable products include antiperspirants, toothpaste, sunscreen, and dandruff which are all considered drugs. The FDA approves drug manufacturers seeking to sell their new prescription drugs after they pass the test in various ways. The first phase includes the laboratory and animal test, which is then followed by the tests in humans to verify their safety and effectiveness if applied to treat or diagnose a disease. Witten, McFarland & Simek (2015) asserts that FDA physicians together with scientists determine whether the drug’s benefits outweigh the known risks and whether it satisfies the quality standards for the approval to be issued. Recent moves by the agency to dispense its role has been a mandate to the pharmacists to dispense consumer guides with some drugs that overtly detail the risks of the medicines. The FDA provides such guides to comprehensively provide intricate information than the drug information sheets that were traditionally issued by the pharmacists.

Also, under FDA’s watch is the regulation of the vaccines, blood as well as the biologics. They are controlled by the organization’s evaluation and research division for biologics that seeks to protect and advance the public health (Gulfo, Briggeman & Roberts, 2016). This is fulfilled through ensuring the products are safe and effective in addition to being accessible to those in need of them. The FDA similarly affords the public with the information relating to vaccines, blood, and biologics to encourage the safety and proper usage of the products. The agency’s trained scientists and medical personnel assesses vaccines by performing rigorous and far-reaching tests to control their effectiveness and safety. Moreover, every significant information is reviewed in a marketing application before the FDA can approve its use by the public.

Tobacco use has been recognized as one of the leading avertable cause of disease and death in the U.S. The Family Smoking Prevention and Tobacco Control Act gives FDA the power to control the manufacture, supply and the marketing of tobacco products with the aim of protecting the public health ("What does FDA regulate?", 2017). As recent as August 2016, the agency finalized a rule that seeks to regulate all tobacco products, which extends to products like the cigars, e-cigarettes and hookah and pipe tobacco as part of their role to improve public health. Prior to the enforcement of this policy by the agency, tobacco products found their way to the market without proper review of their ingredients, how they have manufactured as well as their potential dangers (Yancy, 2008). The agency requires that warnings be provided on the roll-own-tobacco, cigarette tobacco, and other tobacco products. Besides, the new FDA rule restricts access to tobacco products by those younger than 18 years and provides the foundation for the future policies relating to tobacco.

Into the bargain, the agency has the responsibility of demonstrating a greater awareness of the effects of nicotine to the public arena and the healthcare fraternity (Yancy, 2008). A part from protecting the kids and nonsmokers from secondhand smoke to lessen diseases and deaths related to tobacco, the FDA is aggressively tackling the issue of the addiction. The agency is obligated to ensure that it has proper scientific and regulatory foundation to effectively and efficiently ensure the safety of the general public. There is need to strike a fitting balance between regulating and encouraging the development of innovative tobacco products that could be less dangerous than cigarettes. Besides, the FDA is obligated to ensure it addresses the crucial public health issues such as the role of flavors in tobacco products. Above and beyond, the agency is committed to encouraging innovativeness that has the potential to impact positively on public health together with informed policies and efforts that would encourage smokers to quit, protect kids and nonsmokers from secondhand exposure to smoke.

Conclusion

The Food and Drugs Administration is the federal agency that is obligated to oversee the safety and effectiveness of medical drugs, devices, and biologics among other health-related products in the healthcare industry. Even though the agency’s activities are authorized by the Federal Food, Drug, and Cosmetic Act, the FDA is correspondingly in charge of the implementation of provisions in other laws with the notable example of the Public Health Service Act. These two Acts gives the agency the authority to perform its roles in most human biologics. Given that the agency regulates many products, it is divided into five offices to perform agency-wide functions.

As mentioned above, the primary function of the FDA is to oversee the safety and effectiveness of medical drugs, devices, and biologics sold in the United States. Nonetheless, the agency divides its roles and responsibilities into two phases, which are the premarket approval and the post-market approval. The former ensures the agency certifies the drugs, medical devices or biologics before they are marketed to ensure they are safe and effective while the latter ensures the agency tracks and inspects the products to ensure consumers get safe and effective products as well. Other roles of the agency include the approval of drug manufacturers to sell new treatment drugs in the U.S. As a regulator, the FDA ensures that the manufacturers of medical devices provide information that reflects the risk profile of the device in addition to ensuring the devices work effectively and are safe for use by the public. Furthermore, the agency ensures that vaccines, blood, and biologics protect and advances public health by ensuring their effectiveness, safety, and availability when needed. Other roles include the regulation of the tobacco products, regulation of the advertising of prescription drugs as well as the maintenance of communication channels through which information relating to drug safety and effectiveness to clinicians, pharmacists, consumers and the general public is conveyed.

References

Day, P. (2009). The Food And Drug Administration Faces New Responsibilities. Nutrition Reviews, 18(1), 1-5. http://dx.doi.org/10.1111/j.1753-4887.1960.tb01621.x

Fang, H., Harris, S., Liu, Z., Zhou, G., Zhang, G., & Xu, J. et al. (2016). FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science. Drug Discovery Today, 21(10), 1566-1570. http://dx.doi.org/10.1016/j.drudis.2016.06.006

Faris, O., & Shuren, J. (2017). An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials. New England Journal Of Medicine, 376(14), 1350-1357. http://dx.doi.org/10.1056/nejmra1512592

Gulfo, J., Briggeman, J., & Roberts, E. (2016). The Proper Role of the FDA for the 21st Century. Mercatus Research, Mercatus Center At George Mason University, 1-36.

Madden, B. (2009). A dual track system to give more-rapid access to new drugs: Applying a systems mindset to the US food and drug administration (FDA). Medical Hypotheses,72(2), 116-120. http://dx.doi.org/10.1016/j.mehy.2008.10.012

Spears, J., Francer, J., & Turner, N. (2015). Embracing 21st Century Information Sharing: Defining a New Paradigm for the Food and Drug Administration’s Regulation of Biopharmaceutical Company Communications with Healthcare Professionals. Food And Drug Law Journal, 70(1), 143-160.

What does FDA regulate?. (2017). Fda.gov. Retrieved 3 August 2017, from https://www.fda.gov/aboutfda/transparency/basics/ucm194879.htm

Witten, C., McFarland, R., & Simek, S. (2015). Concise Review: The U.S. Food and Drug Administration and Regenerative Medicine. STEM CELLS Translational Medicine, 4(12), 1495-1499. http://dx.doi.org/10.5966/sctm.2015-0098

Yancy, C. (2008). The FDA and Tobacco Regulation. New England Journal Of Medicine, 359(21), 2294-2294. http://dx.doi.org/10.1056/nejmc08204

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