Should The FDA Regulate's Non-Prescription Drugs?

The FDA is responsible for protect public health in the United States by assuring the safety, efficiency, and security of human and veterinary drugs, biological products, medical supplies, food supply, cosmetics and products to rid the United States of radiation. The FDA is led by the commissioner of food and drugs promoted by the President and made by the Senate. They make sure that they can speed up innovations and make medicines more effective, safer, and more affordable for the citizens of this nations. They make sure of this by helping the public get the accurate information they need to use medicines and food to maintain and improve the health of the US citizens.

As children, we rarely look at the back of our chocolate bar or care what elements are in the french fries we indulge in. Whilst getting older, we become more conscious of what is going into our food, and what we put in our bodies. We are more aware of the places that we go to eat, and are constantly looking at reviews. The Food and Drug Administration (FDA) is a government federal agency whose purpose is to ensure our safety as consumers. There are various factors that the FDA oversees, thus requiring a substantial budget. Last year, the over-all spent was 4.8 billion dollars, which is generally made from taxes and user fees from the drug industry. They regulate food consumption,

The FDA home page provides a wealth of information on all aspects of the drug, biologic and medical device approval processes, Radiation emitting instrument, animal and veterinary product, cosmetics and tobacco products to protect the human subjects.

The Food and Drug Administration is the oldest consumer protection agency in United States (FDA 2). From recalls on food products to the monitoring of the safety of our medicine sources, the Food and Drug Administration (FDA) ensures that they are both safe and wholesome (FDA 1). The Food and Drug Administration also ensures that the cosmetics we use won’t harm consumers, and that radiation-emitting product such as microwaves are secure and effective (FDA 1).

What is the FDA and what does it do you may ask? The FDA stands for Food and Drug Administration. They are responsible for protecting the public’s health, and ensure the safety and security of human and veterinary dugs. They also regulate the making, selling and distribution of products. The FDA regulates many things including foods, like additives and supplements, drugs, both prescription and non-prescription, biologics, like vaccines and blood products,

Currently the U.S. Food and Drug Administration (FDA) is responsible for protecting the over all public health of the United States of America (U.S. Food and Drug Administration, 2015). The FDA protects the “public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” (U.S. Food and Drug Administration, 2015). On the Medical aspect, the FDA is involved by increasing new medical innovation to be more effective, safes, and more

The FDA is organized in five different centers. The five centers branch over food, drugs, dietary supplements, animal food, cosmetics, medical deceives, blood production, and biological goods. The organization has the Office of the Commissioner and four directorates to look after the main functions of the company. The main functions of the company included medical products and tobacco, foods

“Pharmaceutical companies have a lot of money invested and push the FDA to approve their applications: “For example, since the 1938 legislation placed the burden of proof on the FDA when it came to challenging or delaying drug approvals, the agency's actions depended primarily on its budget. Larger budgets from politicians could engender greater scrutiny and more challenges of new drugs. Instead of reputation's facilitating such power, increased budgets and the pursuit of the agency's mission could also explain agency actions during 1944-61 “(FDA). “The Revitalization Act of 2007 further empowered the FDA. Legislation aimed at strengthening the US Food and Drug Politics are also played out in the media and indirectly influences whether an application is approved or removed such as

Informed consent is the current guiding principle for the ethical conduct in medical research and originated after the 1947 Nuremberg Code and the 1964 Declaration of Helsinki (Nguyen et al., 2015). The purpose of the informed consent process is to provide potential research subjects information about the nature of the clinical trial, the risks, benefits, underlying procedures, and alternative treatments (Bloswick & Skowron, 2015). The research team must provide the patient with sufficient information so the participant can fully make an informed, uncoerced choice about whether to begin or continue participation in a clinical trial. This process is an ongoing exchange between the subject and the research team throughout the research study.

The Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical device in context to granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, post-marketing surveillance of the medical product, etc. The Pharmaceutical companies seek for FDA approval for a new drug to be marketed through a long process. This process starts with applying an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that drug is safe effective.

Informed consent is an important ethical principle which is applicable to medicine and research. By definition it should be given freely, without coercion (1). All the relevant information which might influence or inform the participant’s decision such as the nature of the study, the risks and benefits must be provided by the researcher (1). Participants should be informed that they can withdraw their consent at any time and withdraw from the study.

Through interviews conducted by the Center for Information and Study on Clinical Research Participation of participants with “extensive knowledge of and experience with informed consent in the United States,” the author claims that reform is needed in the informed consent process when conducting clinical trials, specifically within informed consent documents and their comprehension.

How a subject perceives the risks associated with a clinical trial is a critical piece of informed consent and has been shown to impact patients’ willingness to participate in clinical research (Kim, Tanner, Friedman, Foster, & Bergeron, 2015; Monson, Parlour, Simcock, Fallowfield, & Jenkins, 2011). There are multiple items which can impact a patient’s perception of risk including disease state, gender, ethnicity, age, and factual and subjective knowledge of clinical research.

In order to be legally marketed in the US, many medical devices must be reviewed by the FDA and obtain clearance of their safety and effectiveness to enter the market. The regulations can affect the cost, quality, and availability of medical devices.

Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risk, benefits, and optimal use (NIH.gov, 2016).