Food And Drug Administration (FDA)

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

The FDA is something that many people know about, but do not know what happens within the company. A majority of Americans have heard stories on the news of people making huge acquisitions of how the FDA killed their child by no correctly regulation fast food companies ; or how their husband died for a heart attack because the warning label on his bottle of medication was not correct.

Food and drug administration is a department of U.S health and human services. It’s responsibility is to test the safety and efficacy of new drugs entering the market as well as to make sure that these medicines are quickly accessible to people. The Food, Drug, and Cosmetic Act has been passed in 1938 to ensure that foods other than meat, poultry and fish are clinically hygienic and safe to eat. This act also requires that the food should be labelled according to its content. (FDA.org) Drugs and tobacco are also regulated by FDA and in 1996, FDA strictly regulated the use of tobacco products like nicotine, cigarettes and smokeless tobacco, by children and adolescents because of the increase in diseases prevalence and tobacco addiction. Annually 40000 deaths are attributable to its use and most of them are of premature. Therefore the goal of FDA is to stop the tobacco addiction by minors and prevent the deaths and diseases due to nicotine addiction. (FDA vs Brown, n.d) This essay will cover the food and drug administration’s role in under and over regulating drugs and medicines and how it effects our economy, health care system and patients health and safety.

The Federal Security Agency was created, bringing together related federal activities in the fields of health, education and social insurance.

The FDA is a very structured, governmental agency. The Office of the Commissioner and four directors overseeing

Since it protects the life of all of the citizens in the nation it make sure everything is controlled justly like advancement in technology for the health of the public. So they are responsible of this advancement of technology to help speed innovations that can make medical related things more effective and safer to use. They also need to make sure the public gets that information from products they buy to help the public can maintain and improve their health. Although they are responsible of things that go inside the body for the health of others, they also help, as a significant role in the safety of the nation, working with counterterrorism capability.

The Food and Drug Administration has an important role in keeping people healthy. They dictate food labeling and quality control of the food that reaches grocery store shelves. Along with overseeing safe food practices, they control what medications are brought to the public. When a new drug is brought to the FDA, they will test it extensively before allowing

The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses

PrEP treatment is taken in the form of a pill, called Truvada. Truvada is a combination of two HIV medications (tenofovir and emtricitabine). Truvadais a fairly new drug. It was approved for human use by the U.S. Food and Drug Administration (FDA) and allowed clinical practice guidelines for usage in the America by the U.S. Public Health Service and the Centers for Disease Control and Prevention (CDC) in May 2014. In order for Truvada to be effective, users of PrEP must adhere to taking one pill every day. They must also meet with their healthcare provider every three months to follow up. It is imperative that people who have been exposed to HIV by way of intravenous drugs use or sex seek PrEP to prevent the virus from spreading through the body.

The Food and Drug Administration (FDA) is above the IRB, and the IRB follows the FDA regulations. Therefore IRB has the authority to monitor, approve, or disapprove research because they follow the FDA regulations. The IRB helps to make sure that patients are not just looked at as test subjects but as human beings.

There are many aspects of the Food and Drug Administration’s current regulations that are of great concern to many. For instance, the regulation of GMOs, or genetically modified organisms, is a largely debated subject, especially in relation to genetically modified food, or GM food. As described by nongmoproject.com, “GMOs, or “genetically modified organisms,” are plants or animals that have been genetically engineered with DNA from bacteria, viruses, or other plants and animals. These experimental combinations of genes from different species cannot occur in nature or in traditional crossbreeding.” Most of the American population may not even realize this, but according to nongmoproject.com: “In the U.S., GMOs are in as much as 80% of

Pharmaceutical products, medical devices, veterinary medicines and food supplements, all these products are subjected to regulations stated in the government policies to protect public health. All healthcare organisations or companies are constantly being monitored by a regulatory affairs department or commonly known as regulatory pharmacists to ensure their compliance with all the regulations and laws concerning their business. Regulatory pharmacists always adhere to ethical standards and refrain from abuses of power which make them true leaders who wield their power to achieve desired

Clinical trials evaluating the use of Yttrium-90 (Y-90) transarterial radioembolization for hepatic tumors date back to the 1960s. The U.S. Food and Drug Administration (FDA) approved the use of TheraSphere® (BTG, Ontario, Canada) particles for hepatocellular carcinoma (HCC) via humanitarian device exemption (HDE) in 1999 and SIR-Spheres® (SIRTex Technology Pty, Lane Cove, Australia) particles for colorectal cancer metastases in 2002. Since then….[talk more about recent vents in the field]. Transarterial radioembolization has been reported to improve overall survival to 15.4-17.2 months (1). The burgeoning use of Y-90 radioembolization in the treatment of liver tumors requires interventional radiologists to make clear documentation in procedure reports in order to obtain authorization and maximize reimbursement.

In the United States, The Food and Drug Administration has the power to decide what is and is not safe to be consumed by the human body. The pharmaceutical industry makes billions a year, they develop, design, add chemicals to, and produce hundreds of new drugs a year. It has been argued by many scientists, economists, and average american citizens that the FDA regulates and approves of drugs based on biased opinions and for reasons other than the health of consumers.