The Purpose and Actions of the Food and Drug Administration

Known as the oldest federal consumer protection agency; the Food and Drug Administration agency has worked efficiently to ensure safety in our nation's food supply, as well as the distribution of medical drugs. It all began with the passage of the Pure Food and Drugs Act back in 1906, which was a law that prohibited interstate commerce in adulterated and misbranded food and drugs. This act was advocated by Harvey Washington Wiley, a chief chemist of the Bureau of Chemistry of the U.S Department of Agriculture, who sought to fix the public’s reaction to The Jungle, by Sinclair. A book that accurately described the conditions of food factories back in the early 20th century. The shocking unhygienic image the book gave factories, lead to the public's approval for the new act and the creation of the FDA. Clearly depicted in its history, the creation and purpose of the FDA has always been to regulate and ensure citizens safety in what they intake on a daily basis, whether it is food or off the counter medication. The real question is: how successful have they been to maintain that purpose. In order to answer this question one must look into the agencies structure, projects, positive or negative actions, fundings, oversight and their past court case.

To start off the FDA branches off from a larger system and contains its own independent hierarchical system to carry out its responsibility of ensuring the public health. The FDA is a small agency within the Department of Health and Human services. It is oversighted by the subcommittee on health care, benefits and administrative, with the chairman Jim Jordan. It consists of the Office of the Commissioner and four main functions: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. In order to carry these functions out, there is a total of 30 members who fall into one of the eight roles: commissioner, deputy commissioner, chief financial officer, chief of staff, acting chief of scientist, chief counsel, associate commissioners, assistant commissioners, and center directors. While the commissioner oversees all actions in the the agency, the other positions plan, implement and advocate for new regulations that will further secure public health. The current commissioner, leader, is Scott Gottlieb, a man who supported the implementation of the Medicare drug benefit during the time he was a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services. In addition to supporting Medicare drug benefit, he supported improvements and coverage for new medical technologies. By 2013 he served on the Federal Health Information Technology Policy Committee to advise the Department of Health and Human Services on healthcare information technology. Understanding, the background of the commissioner of FDA allows one to see how he has consistently advocated for public health whether is was in medical services or new medical technologies. With having that said, it may appear to be that the leading focus of the staff are interests correlated to Gottlieb’s place of expertise; which will later be clarified when we discuss the current agency projects. It’s important to look at commissioner’s background, because sometimes their past jobs or positions may contradict with the functions of the agency. Also, it might give us a clue to what fields the agency will function towards in the future. From the agency structure and leadership one may not be able to see how successful the agency has been, however one has an idea on how it functions and who’s in charge. The FDA has actively been working on projects that pertain to medical devices and nutrition research. One of the many projects that they have been actively working on is the Medical Device Epidemiology Network Initiative (MDEpiNet). This is a network, associated with Epidemiology Research Program, that seeks to conduct research on medical devices before they go out on marketing. They want to test out the safety of these devices before they are utilized on patients. As mentioned before, the agency might have interest in new medical technology safety, due to it’s commissioner. Despite the possible reasoning for their focus on the subject, it is an essential and prominent issue that should be looked closely. This project discloses how the agency, overtime, has expanded its horizons from food and medical intake to technology- all in attempts to ensure public health. With the new medical technological treatments that have risen, it is essential that the FDA expands their regulation into those new fields. One can say their purpose is being succeeded to a certain extent because they are regulating medical machinery that comes incontact with the public. Aside from moving towards medical technical innovations, the FDA has been conducting nutrition research in the form of national surveys. The Research on Labeling, Nutrition, Diet, and Health, is a survey that sought dietary patterns within demographics. In one particular study in 2016 named, As Much Calcium as a Glass of Milk!' Understanding American Consumers’ Preferences for Fortified Foods, they found that the white population prefered fortified foods more than Blacks and Hispanics. The researchers correlated the results to lack of health consciousness. It can be said that the results of the study are a bit questionable. Is it the FDA’s fault? Are they in power to better the dietary habits of a certain demographic? The FDA is made to ensure public health by regulating and inspecting the food one buys off the counter, however one's eating habits should be independent. It is a bit strange to see a large demographic be “unconscious about health”. This study denotes a much larger problem that may or may not be out of the control of the FDA. With having that said, FDA is attempting to maintain it’s goal to secure public health, however there are certain issues that may be hindering equity within the health field- their efforts may not be accountable for everyone.

Like humans, agencies have successes and faults. Recently, the FDA has proven itself to be an active advocator for public health by utilizing their power to increase food inspection and continue medical studies. On December 26, 2017, the commissioner, Gottlieb, made a statement about trying to quicken the pace of recall when a product is claimed hazardous. He states that he’s been working with the Strategic Coordinated Oversight of Recall Execution, score team, to create a strategy for 2018 to fasten the pace. In addition, on December 28, 2017, the FDA allowed the marketing of the Dermpace system, the first shock wave device to treat diabetic foot ulcers. Being about to allow the marketing of medicine that may help millions of patients is a success that the FDA has allowed to occur. Also, being able to better the regulation of food denotes how the FDA has managed to keep their authority over the food we intake. With having that said there has been a large controversy over the fact that the FDA allows GMO infested produce to be sold as well as foods with toxic chemicals to be sold. Many argue that GMOs are harmful to people because recent studies have shown an increase in cancer and diabetes. They state that there are not enough studies conducted to be completely safe (1). A couple of chemicals that concern these researchers are Acesulfame Potassium, Aspartame, BHA and BHT, Indigotine, and Fluoride - all chemicals that are FDA approved. Along with these chemicals come serious health problems from lung cancer to immune disorders and other more hazardous conditions. Finding this information is alarming, making it clear that the FDA is not completely honest with their main motive. These are just five out of many that may be unknown to the common person. Throughout the entire research, we find that the FDA is properly organized with well educated people in the field and various positive attempts to keep a good public health. The addition of this information breaks down the image they put out with the people and their attempts because these chemicals completely contradict their main purpose. The FDA’s negative actions include tolerance for toxic chemicals- something that harms everyone from the nation and deteriorates their efforts. It’s important to be knowledgeable of who funds agencies to understand if their efforts are correlated to monetary motives. In the FDA records of 2010 it highlights how the department of health and human services funded a total of $25,0099,004. This clarifies why most of the FDA focuses in the last decade have focused on medical technological innovations or medicine. The Environmental Protection funded $570,000 while Department of defense funded $3,775,148. All funds given to the agency to further studies on medical care and radiation control. Similarly the Department of Homeland security funded $304,000 and nuclear regulatory commission funded $125,00 for radiation control. The funds added up to a total estimate of $44,355,452. These numbers denote how the FDA is accountable for most of a lot of these departments or agencies to a certain extent. These funds are not done just as a gift, but as a budget for the FDa to carry policies or regulations in those fields. The estimated funds of 2011 roughly parallel those of years before; $45,331,272.

Last year's FDA budget parallels those of past years with a striking increases per year. The budget jumped $358 million from 2016’s budget to $5.1 billion. The main funders still consist of Human Drugs, Prescription drugs, food, and food inspection. Despite the funding and budget difference between the years, they do not denote any significant change because the FDA’s main focus are still medical issues/innovations. From this information one can understand why the FDA focuses so much on medical innovations, they are highly funded to work on them. Also, it contributes to their main purpose- secure public health. The FDA has stumbled upon judicial controversy aside from the problem with allowing genetically modified foods. One popular court case is the FDA v. Brown & Williamson Tobacco corporation, a court case that aimed to answer the question: Does the Food and Drug Administration have the authority to regulate tobacco products as 'drugs' and 'devices' under the Food, Drug, and Cosmetic Act? Back in 1996 the FDA settled that they can regulate tobacco products because of the containment of nicotine that makes them a drug device. The Tobacco industry challenged the FDA’s authority by claiming that the Tobacco should be considered a customarily product not drug device. They stated that there wasn’t sufficient evidence to prove that the “Drug device” caused any harm on the body. The supreme court ruled that the FDA had the authority to regulate cigarettes and no other agency could interfere that authority. Due to the wealth of the tobacco industry, it felt the authority to question the power of the FDA. This should be alarming because it shows how other big corporations/industries can step into the legislative authority. Who knows how many times corporations have found its way around the agency or congressional legislative. Despite the possible corruption that the Tobacco industry would have caused, the FDA managed to stay true to it’s true efforts of maintaining the public health secured. However this does not dismiss the fact that the FDA has allowed GMO foods and other hazardous chemicals be added to our food. To conclude the FDA has had a couple successes in their efforts to secure the public health. It is shown through their, structure, oversight, projects, positive or negative actions, fundings, and their past court cases. The structure allows one to know what the FDA is all about and who makes up the agency. It does not necessarily tell one the degree of success the FDA has however understanding the people that work within the FDA helps one see the focuses of the agency. Their projects help one see if their efforts are working towards their purpose, securing public health. Based on the medical devices research one can see how the FDA is taking care of people’s health by looking at possible deficiency in medical devices. In addition the nutrition researches raised questions on how much control the FDA has. If they are at fault whya specific demographic in the nation is “unconscious about health” or if it is a problem out of their hands. The FDA has deteriorate its efforts by allowing toxic chemicals in our food and potential triggers of cancer or diabetes in GMO foods. These actions question their success their efforts to secure the public health. Majority of the FDA budget comes from the DHHS and pharmaceutical agencies to further the research in medical innovations and technology. This shows how the FDA’s focus is driven to a certain extent on budget.

The court case FDA v. Brown & Williamson Tobacco corporation highlight potential barriers for the FDA to carry out its purpose. Despite, all the efforts of the FDA immense control and their tolerance for toxic chemicals in certain foods rises uncertainty in them. It is true they have done a lot of good towards the medical field and even have advocated for further food inspection, however it does not dismiss the fact they reinforce the passage of foods that can put the public's health at risks.