Food and Drug Administration, Research Paper Example
Words: 2357Research Paper
The Food and Drug Administration (FDA) is an agency within the U.S. Departmnet of Health and Human services, responsible for overseeing the core functions of the agency: Foods, Operations, Medical Products and Tobacco, and Global Regulatory Operations and Policy (FDA, 2012). Within these overarching categories, the FDA has taken responsibility for a number of items, such as basic food safety, vaccines, medicines and medical devices, and even veterinary products. It also has other areas of enforcement, such as those that are not directly related to food or drugs like sanitation requirements and sperm donation.
The “Why” and “How” of the FDA
For the FDA, its development was something that arose out of need. Within the context of food safety in the 19th and early 20th century, there were few ways to streamline the safety measures of food and pharmaceuticals. It was apparent that stronger watch of these crucial items was necessary.
“Why” – The Growing Need
One easy way to see this is with the Vaccine Act of 1813. According to Kurian, the act that encouraged vaccinations against smallpox was the first Act that concerned consumer protection and pharmaceuticals (1998). The short-lived Act, which was repealed in 1822, was the first item to be seen – bringing the important issue of consumer safety to light.
Coinciding with the increased need for consumer safety, the beginnings of today’s FDA were already in place with the Division of Chemistry. In 1862, a single chemist formed the beginnings of the agency that had a staff of 9,100 employees and a $1.294 billion budget in 2001, according to Swann (2009). Later, in 1883, the chief chemist Harvey Washington Wiley’s presence coincided with a prime time in terms of awareness for possible food hazards.
This time of awareness was certainly notable. Most notorious perhaps was the efforts of muckracking journalist Upton Sinclair, who infamously released the 1906 novel “The Jungle.” In this time, the Division of Chemistry began looking into the state of food and drugs in America. One issue, in which several deaths resulted from diphtheria antitoxin from a horse, resulted in the 1902 Biologics Control Act, and was responsible for the Center for Biologics Evaluation and Research – later one of the centers of the FDA and that responsible for biological products under applicable federal laws (FDA, 2012).
“How” – The Food and Drug Act
Behind Wiley’s presence, the Pure Food and Drug Act was signed – also known as the “Wiley Act” – in June of 1906 by President Theodore Roosevelt (FDA, 2009). The important Act signified a dedicated approach to help control the safety of foods and drugs in America. A couple of decades later, the Division of Chemistry would become the FDA.
While 1906 is generally considered to be the starting point of the FDA, it can be a bit misleading. As seen in this analysis, the agency certainly existed before the 1906 Act, in the form of the Division of Chemistry. It was not named FDA until later, in the late 1920s and in its current state, in 1930. As a side note to the 1906 Act, the Food, Drug, and Cosmetic Act of 1938 replaced the former Act as a more comprehensive form.
From the initial Act, the FDA came to realize its presence in food and drug safety. However, with the 1938 Act, the FDA increased its power and effectiveness. The FDA began designating drugs as safe for use – under the advisement of a medical professional. This amendment, the Durham-Humphrey Amendment, helped the FDA turn the corner, preparing it for a number of important developments throughout its history.
Important Events with the FDA
A number of important events have occurred due to the FDA’s presence. Monumental changes for the safety of consumers have been seen, importantly following the landmark Acts in the agency’s history. Some of these examples are ideal representations of the effectiveness of the agency.
One interesting early battle with the FDA was with the Coca-Cola company. With the initial Pure Food and Drug Act, there was an effort to ensure products were labeled correctly. Also, the FDA wanted to outlaw unsafe products – as well as ineffective products.
The case United States v. Forty Barrels and Twenty Kegs of Coca-Cola saw the battle develop with limited success, though the government won when it reached the Supreme Court – the two sides later settled on caffeine amount. With the presence of coco leaves that contained trace amounts of cocaine, the FDA was concerned about this, the amount of caffeine in the beverage, and the claim that it had cured headaches (Hamowny, 2007).
After the case reached the Supreme Court, and the two sides settled, Coca-Cola voluntarily reduced the amount of caffeine in the product (2007). In order to avoid further litigation, the company offered to pay all legal costs to settle. According to Hamowny, Wiley had resigned in 1912, thus leading to the acceptance of the offer, as no one at the FDA was looking to keep the pressure against Coca-Cola (2007).
In 1951, The Durham-Humphrey Amendment was passed. The amendment followed other developments within the FDA. Earlier, the FDA began to determine which drugs were or were not safe for consumers. With the amendment, further powers were given to the FDA to help promote customer safety.
With the bill, the statement “Caution: Federal law prohibits dispensing without a prescription” must be placed on prescription drugs. Until the bill, there no law that separated drugs from being available by prescription drugs. Thus, an important step was taken in the direction of drugs that are safe – only under the supervision of a doctor. Other items were granted in the bill, such as legal transmissions of prescriptions and the ability of a doctor to refill prescriptions in accordance of the initial prescription. Overall, the bill was an important milestone that aided consumer safety with regard to drugs.
Work in the AIDS Era
In the 1980s, a number of organizations put pressure on the FDA due to the delay of medications that were approved. This had a number of effects that allowed the FDA to expedite processes in the approval of medications, which eventually led to important improvements. Overall, it remains a significant event in the long history of the FDA.
One such confrontation occurred in October of 1988. Nearly180 arrests occurred as a result of a large protect to unnecessarily delay medication approval (ACTUP, n.d.). Two years later, thousands of estimated lives were lost, due to delays in marketing and approval for related medications. These developments led to important advances for the FDA.
New rules were developed for the approval of drugs related to life-threatening diseases. It also expanded the pre-approval process for those with limited access to medications. Later, in 1992, the increased timeline for approval were expanded (Orlando, 1999).
Family Smoking Prevention and Tobacco Control Act
On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act was signed by President Barrack Obama. Relating to the power of the FDA to regulate the tobacco industry, this development represents a more recent example of how the FDA has progressed. This Act has demonstrated how the FDA has recently responded to such a health threat.
With plenty of support in the Senate (House.gov, 2008), the Act instituted a number of provisions that further regulated tobacco. For example, it limited the marketing efforts to young smokers, added significant warning labels that were mandatory, and allows the FDA the ability to change tobacco product content (FDA, 2010). Overall, it gave the FDA the authority to regulate the marketing, content, and sale of tobacco products.
General Importance of the FDA
Overall, it is easy to characterize the importance and significance of the FDA. With a long list of responsibilities, and a nod toward their role in the historical development of consumer-based health, the FDA has come a long way towards the protection of the American public. Looking at the wide range of the FDA today, the agency has certainly made their mark in terms of safety, research, and regulations.
One of the most significant areas of the FDA’s control is seen with medications. As seen prior in this analysis, the FDA has made significant strides in terms of developments to benefit the public. As a result, a current system exists that allows for the public to use medications safely and with as much information as possible.
The approval process has benefited the FDA’s ability to protect the public significantly. This implementation allows the FDA to deem that the product is OK for the public to have – and that it meets the guidelines for ingredient information, safety standards, and appropriateness in terms of it being for prescriptions, over the counter, or perhaps both in different forms. As a result, consumers can use medications in the right way, with the OK from the FDA and their doctor, as appropriate.
Another example of this is seen with medications that may be unsafe for consumers. The FDA has seen several examples of unsafe medications that were either unapproved, or recalled after research had confirmed its unsafe status. From pregnancy medication that were deemed unsafe, to many others, the FDA has made their presence known for the protection of consumers.
In many cases, the FDA has provided information regarding the nature of a drug for consumers. For instance, some medications are not simply unapproved – but given warnings for consumers who use it. An example of this can be found in Accutane, in which the FDA warned about stunted growth in its medication guide – that it “may stop long bone growth in teenagers who are still growing,” along with other warnings (FDA, 2010). The brand name was pulled, though isotretinoin is produced by other manufacturers.
From the beginning of the FDA, including its original state before its current name, it has placed an emphasis on food safety. From Sinclair to the present times, the influence of the FDA in food safety is undeniable. This is perhaps the most significant area of influence for the FDA, as its name would of course suggest.
Besides meat products from traditional domesticated animals (this is under the jurisdiction of the United States Department of Agriculture Food Safety and Inspection Services), the FDA has a great deal of responsibilities with consumer food. Over the years, a number of critical developments have helped to aid consumer safety. For instance, with the requirements of nutrition labeling, consumers are able to make healthy decisions and know what the ingredients are in their food. While the FDA does not test dietary supplements, it can take action if it is unsafe – and requires these items to have a disclaimer on it that it doesn’t treat or prevent disease.
The FDA has a long history that precedes its current name. Due to the growing need for a regulatory agent for food, drugs – and a number of related areas – the FDA emerged in the early 20th century. Through a number of Acts and important developments, the current, powerful state of the FDA can be seen.
The scope of the FDA is quite impressive. Of course, the FDA has a great deal of responsibilities within the topics of food and drugs. However, it extends much beyond these two varied items: vaccines, biotechnology, cosmetic products, veterinary products, and tobacco products also fall into its jurisdiction. As a result, the now-powerful agency that arose from a single chemist represents a number of integral areas in consumer safety.
The development of the FDA is easy to see within the context of a number of important developments. From the Durham-Humphrey Amendment to the AIDS era – and including recent developments like the Family Smoking Prevention and Tobacco Control Act – the FDA has experienced a number of events that is has responded to, either as a reaction or pre-emptively, to increase its status in protecting Americans’ health. Of course, some events were not particularly bright points within the American timeline.
Currently, the FDA is a powerful resource for all things pertaining to consumer safety. While some products are outside of its jurisdiction, such as some meat products and tap water, for example, the FDA takes a leading role in a varied number of products. Over the years, there are several examples of it disallowing dangerous products on the market, or responding quickly to a less-than-desirable product. The FDA continues to try to protect consumers against dangerous food, drugs, and other products under its jurisdiction.
However, the FDA is not “merely” an agency that regulates products. Today it can be considered a leading source for obtaining information on these products. Also, it provides educational tools for consumers, professionals, and students and teachers. Like many other agencies in the government, the FDA can be a valuable place to obtain information – similar to the United States Department of Agriculture’s efforts.
Overall, the FDA has responded to an incredibly important need in the United States. It has responded by building a now-powerful agency that has taken a proactive approach to the wide range of topics with which it deals. In its history, it is easy to see its impact and the changes that have resulted – all speaking to the increased safety of consumers in the country.
ACTUP (n.d.). ACTUP Capsule History 1988. Retrieved from http://www.actupny.org/documents/cron-88.html
FDA (2009, June 18). FDA History – Part 1. U.S. Department of Health & Human Services. Retrieved from http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054819.htm
FDA (2010, January). Medication Guide. U.S. Department of Health & Human Services. Retrieved from http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085812.pdf
FDA (2010, June 24). Tobacco Control One Year Anniversary. U.S. Department of Health & Human Services. Retrieved from http://www.fda.gov/TobaccoProducts/NewsEvents/ucm216493.htm
FDA (2012, May 10). About the Center for Biologics Evaluation and Research. U.S. Department of Health & Human Services. Retrieved from http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/default.htm
FDA (2012, May 23). FDA Fundamentals. U.S. Department of Health & Human Services. Retrieved from http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192695.htm
Hamowy, R. (2007, April 7). Government and Public Health in America. Northampton, MA: Edward Elgar Publishing.
House.gov (2009, January 12). House.gov. Retrieved from http://clerk.house.gov/evs/2009/roll335.xml
Kurian, G. T., Harahan, J. P., Keller, M., and Kettl, D. F. (1998, April 2). A Historical Guide to the U.S. Government. New York: Oxford University Press.
Orlando, V. (1999). “The FDA’s Accelerated Approval Process: Does the Pharmaceutical Industry Have Adequate Incentives for Self-Regulation?” American Journal of Law and Medicine, 25(4): 543-68.
Swann, J. S. (2009, June 18). FDA’s Origin. U.S. Department of Health & Human Services. Retrieved from http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm124403.htm
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