The Food And Drug Administration

Raisio, a Finnish grain and chemical company, is the proud owner of a product that has been deemed one of the ten most important nutritional innovations in the world (“Benecol®,” 2010). This product is a unique compound composed of plant stanol esters and has been scientifically proven to help lower cholesterol levels in humans. With the prevalence of high cholesterol in the world population and the incidence of mortality associated with a high cholesterol level, it is no wonder that Raisio had a deep desire to share

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.

* Origin of Drug: Dutch word droog meaning dry for dried herbs and plants that were the 1st medicine.

different from that which they had on record, but all the other certificates and credentials checked out, including the Drug Enforcement Agency (DEA) ID number, doctor licenses, and pharmaceutical certificates. In this incident, a malicious hacker had compromised the medical center’s credentials and was attempting to take out a large line of credit with the pharmacy to purchase drugs. The pharmacy’s act of calling the medical center to double check the order saved them from losing $500,000 in prescription drugs, and saved the medical center $500,000 being withdrawn from their account (Center for internet security, 2017).

The FDA’s Center for Drug Evaluation and Research (CDER), the largest of six FDA centers, plays an essential rule in public safety and health by ensuring that the available drugs in the market are safe and effective for their proposed use. CDER mission is to regulate new drugs, including over-the-counter and prescription treatments, and provide doctors and patients with necessary information to use these drugs wisely and efficiently. CDER, however, is not responsible for testing drugs even though the Center Office of Testing and Research partially investigates areas of the drug quality, safety, and effectiveness.

U.S. Food and Drug Administration (FDA) drug review bears a structural similarity to many decisions made by other regulatory agencies: high uncertainty, low reversibility, avoidance of observable error, and high political stakes that induce lobbying by interested parties. This project explores the policy lessons to be learned from viewing FDA drug review as a politically shaped exercise in information processing. I argue that the incentives facing regulators induce limits on the degree to which drug review can be accelerated, that the same incentives could render privatization initiatives problematic, and that political pressures could play a useful role in identifying priority drugs. Patients, more than pharmaceutical firms, shape the

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.

A federal agency is an administrative division within the federal government to serve specifically assigned purposes across executive departments. The Food and Drug Administration (FDA), serves as a federal agency to The United States Department of Health and Human Services (HHS). The goal of the HHS is to protect the health of all American citizens and provide essential human services. To further the protection of public health, the FDA was created to protect and promote public health through regulation and supervision offood safety, tobacco products, dietary supplements, prescription and over-the counter pharmaceuticals, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed and veterinary products.

Drug Administration Reauthorization Act of 2017, Legislation that includes the Over the Counter Hearing Aid Act designed to provide greater public accessibility and affordability with over-the-counter (OTC) hearing aids” (The Hearing review). In the United states today there is “an estimated 30 million to 48 million Americans who have some sort of hearing loss that diminishes the quality of their lives” (Jane Brody). As a future Audiologist it is easy to see why this a big deal. Audiology is “the science of hearing, balance, and related disorders” (ASHA) and Audiologist are the professionals who help individuals with mild to serve hearing loss, gain access to the

The institutional review board (IRB) role is to develop, guide, monitor, and approve research before it starts. The IRB helps to protect the human subjects that are being used for research and make sure the benefits outweigh any harm to the patients. If any of the IRB findings indicate that the harm outweighs the benefits, then research comes to a halt. They make sure that research is conducted in an ethical manner ( ).

Institutional Powers have always affected my life in many ways. The main institutional power that control both positive and negative consequences of my life would be the FDA the Food and Drug Administration. The first way they control my life is they regulate all human and veterinary drugs in our country. Second, the FDA is responsible for protecting the public health and products. Lastly, they supply and control the entire United States Food supply. I believe that this specific governmental institutional power is 100% the authority over my life. The FDA needs to care more about the general health of the public and take into consideration how they play a major factor in the health of our bodies, minds, and environment as well.

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.

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.

Phytosterols are natural sterol with molecular structure similar to cholesterol. Produced mainly by plants it’s a component from the plasma membrane. Beyond natural source (vegetables, oils, grains), a lot of food products has been supplemented with phytosterols, because of their property to decrease the risk of atherosclerosis through reduce the level of low density lipoprotein (LDL). Despite the beneficial effects of phytosterols, increase the consumption can result in negative collateral effects. The phytosterols are susceptible to oxidation in presence of oxygen, ozone, warm, light and transition metals forming the oxidized phytosterol products or oxyphytosterols. Some studies shows that the oxyphytosterols can be envolved in formation

According to the regulations established by the FDA in 1992, “Under this policy, foods, such as fruits, vegetables, grains, and their byproducts, derived from plant varieties developed by the new methods of genetic modification are regulated within the existing framework of the act” (FDA). In other words, instead of creating new regulations that are specific to these completely unique food products, they are put within the umbrella of other “natural” products. As time passes it appears to be harder to establish strict regulations to manage genetically modified food. According to the Center for Food Safety the most current propose of the Food and Drug Administration establishes that agricultural biotech companies should notify the FDA within a period of 120 before the companies proceed to introduce the product to the market. Regrettably, there is not mention of any regulation that requires assessment for health and environmental safety. This leave the companies with the freedom decide the kind of test that they want to perform if they decide to do so. But most important if this proposal is successful approve it will mean that the companies will have the right to freely even control what they want to include on their labels, which it will most likely exclude the mentioning of genetically modified food.