Evaluation of Agency’s Ethics, Cooperation, Leadership, and Legal Decisions
As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) performs one of a critical functions of the federal government. FDA’s reach is enormous regulating products that represent 25% of all consumers spending in the U.S. The agency regulates a trillion dollars’ worth of products, roughly 25 cents in every dollar spent. The company regulates 80% of the U.S. food supply and products that are health related such as prescription drugs and devices, electronic products that emit radiation, animal products, cosmetics, and manufacture of tobacco products. While FDA has to act quickly to get products to the market, it ought to be careful to make effective decisions. The public accuses it of laxity whenever a drug or device, for instance, must be recalled over unpredicted adverse events. FDA faces innumerable challenges in its operations.
In “Politics of pain: Drugmakers Fought State Opioid Limits Amid Crisis”, Whyte, Mulvihill and Wieder (2016) talk about how drug makers falsely claim to be combating painkillers addiction. While they claim to make efforts to fight the addiction, they send messages that encourage usage of painkillers without prescription. FDA is not doing much to regulate these drug makers and is instead falling for their false claims about combating pain killer addiction. Deaths resulting from prescripting pain killers have doubled over the years. Lobbyists are pushing for tighter prescription restrictions. According to Perrone and Wieder, FDA has emphasized the importance of painkillers despite the escalating addiction to prescribed painkillers (2016). The key function of FDA is to protect consumers. Instead, FDA seems to be siding with the drugmakers.
Quinn and Young in “Why the FDA Does not Know What is in Your Food” bring to light the fact that FDA has rules and regulations that undermine its functions (2015). A 57-year-old legal loophole allows food processors to add substances to their food without seeking the approval of FDA. This law exposes Americans to potential health risks, because it allows food companies to add preservatives, flavors and other ingredients that may be unfit for human consumption. Regulation of food products is one of the biggest challenges faced by FDA today. The law allowing food companies to add ingredients without undergoing a safety review challenges the functions of FDA.
Politics and Leadership
Since FDA is a federal agency, it is run by a commissioner who must be confirmed by the senate. The federal government funds FDA. Being answerable to the legislative arm of government, the agency is sometimes caught up in fights that have nothing to do with its functions. Politicians may raise issues concerning FDA or they may make decisions regarding FDA for political reasons. In the mid-1990s, for instance, Republicans tried to strip FDA of much of its power to review drugs, because they wanted to cut government down to size (Hawthorne, 2013). During George Bush’s administration, the policy of preventing patients from taking drugmakers to court was due to a larger campaign against trial lawyers and multi-dollar court wars.
Appointments to the advisory committees should be based on scientific credentials. Only in rare cases, members of the administration have been asked about their political leaning or questioned about controversial issues. FDA’s core responsibility is to regulate food and drugs in the United States. Education consideration is therefore important when appointing members for FDA committee. By having scientists on the committee, FDA is able to stay above politics and most importantly have professionals to deal with matters concerning food and drugs.
Lobbying is another element of FDA leadership. Lobbying theoretically helps FDA stay above politics. Officially, as a federal agency, it is not supposed to lobby Congress. However, as with any other agency, there is plenty of seepage at the edges. FDA openly runs a sizable office of Legislation that is tasked with answering congressional requests for information, and the line between answering and lobbying can be nearly invisible. Nothing stops FDA employees from buttonholing colleagues in other parts of the executive branch or meeting with lobbyists from other organizations.
FDA’s responsibilities and powers have grown over the decades. The agency’s activities now protect the health of the U.S. citizens against unsafe foods, medical, biological, radiation emitting devices, drugs, cosmetic and other potential hazards. The acts which the agency administers include: Tea Importation Act, Federal Food, Drug and Cosmetic Act, Filled Milk Act, Import Milk Act, Medical Device Amendment of 1974, Radiation Health and Safety Act and Public Health Service Act (Hawthorne, 2013). FDA consists of six product oriented bureaus, a national Center for Toxicological Research, a nationwide field activity and supporting functions comprising the staff of the office of the commissioners. FDA must make regulatory decisions which ensure that consumers are protected from many risks and hazards. Such decisions are increasingly difficult because of conflicting evidence, new hypotheses and increasing awareness of relationships among all health variables. Sound decision making in the scientific environment involves the use of many sources of information, including the general scientific community, the regulated industries, and specialized research organizations in both the public and private sectors.
FDA has undertaken a number of research-related activities pertinent to its mission. The agency establishes or improves regulated product standards. The federal regulator’s duty is to develop new research methods for use in identifying and evaluating potential hazards and for use in improving the efficiency and reliability of regulatory surveillance approaches. FDA is involved in the validation of data on new product in the market. Validation involves conducting tests to ensure the new products do not pose health threats to citizens. In light of technological advances, FDA re-evaluates the safety of previously approved products. The agency establishes contamination tolerances for regulated products. FDA simulates and analyzes commercial production to establish appropriate manufacturing guidelines. The instirution is responsible for certifying the safety and potency of regulated products.
FDA has a problem the law that allows food companies to add ingredients without government intervention. The loophole allows food companies to declare their ingredients safe. The biggest concern is that food companies continue to add new ingredients without informing consumers. People are, therefore, exposed to preservatives and flavors that are neither reviewed nor regulated by FDA. These unchecked additives could be a cause of short-term and sometimes long-term illnesses. Politics is another legal issue that is affecting the regulations of FDA policies. Being federal, the agency is often caught between Democrats and Republicans fights, and in the end FDA is used as a pawn. Regulation of policies is affected during Democrat-Republican power struggles.
A law that allows the evaluation of all new ingredients should be made. Thus, only safe and healthy ingredients will be added to the food we consume. Using FDA as a political pawn is unethical and puts the lives of people at risk. Selection of committee members of FDA board should be based on academic and scientific merit. By doing so, FDA will be run by members who are not political and thus cannot be swayed into politics. Sometimes, the agency selects committee members based on their political affiliation to ensure that all political groups are represented. However, the selection method should only be a means of ensuring equal representation and not for functionality purposes. Using politics as a means of selection limits the functions of FDA and continues making the agency a political pawn. Finally, lobbying is another strategy that could help FDA to set itself apart from politics. Currently, FDA is involved in lobbying activities. However, these activities need to be intensified, especially in the fight against prescription painkillers.
FDA should focus its energy and resources on its primary duties of food and drug administration. Painkillers have been a nagging problem to FDA for the last decade. With people getting addicted to prescribed painkillers, FDA should ensure that prescription of these painkillers is regulated to avoid health issues. Moreover, FDA should review its laws and regulations to keep up with the changing world, because some FDA laws may be obsolete or restraining. Finally, FDA should utilize its resources thoughtfully to prevent funds from running out.
Hawthorne, Fran. (2013). Inside the FDA: The business and politics behind the drugs we take and the food we eat. Hoboken, N.J: Wiley.
Perrone, M. & Wieder, B. (2016). Pro-painkiller echo chamber shaped. The center for public integrity. Retrieved from https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic.
Quinn, E. & Young, C. (2015). Why the FDA does not know what is in your food. The center for public integrity. Retrieved from https://www.publicintegrity.org/2015/04/14/17112/why-fda-doesnt-really-know-whats-your-food.
Whyte, L. E., Mulvihill, G., Wieder (2016). Politics of pain: Drug makers fought state opioid limits amid crisis. The center for public integrity. Retrieved from https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis.