U.s. Food And Drug Administration

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.

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If 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.

The FDA has lowered drug approval standards, pharmaceutical companies have ensured that the FDA will be compensated for approving these medicines. The Pharmaceutical campaigning led to the Prescription Drug User Fee Act (PDUFA) of 1992 and it was reauthorized in 1997. This allows the FDA to collect fees from pharmaceutical companies to review new

The United States Food and Drug Administration, also known as the FDA, is the government agency “responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological product, medical devices, our nation’s food supply, cosmetics, and product that emit radiation.” It is “also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable. Created under the Theodore Roosevelt administration under the 1906 Pure Food and Drugs Act, the FDA still operates as a part of the federal bureaucracy. What if the very institution supposed to be looking out for the public health and advancement of medical

In 2008, the Food and Drug Administration (FDA) approved the use of Moxatag, a once daily extended release formulation of amoxicillin, for the treatment of streptococcal pharyngitis. The clinical study results indicated that Moxatag was as safe and effective as penicillin V, the first drug of choice for the treatment of pharyngitis (Infectious Disease Society of America, 2013). Moxatag is the only once daily medication FDA approved for the treatment of pharyngitis. The manufacturer claims that once daily dosing will improve compliance, thus improving patient outcomes. Moxatag is very expensive relative to immediate release penicillin. Price comparisons found a difference of 144 dollars between Moxatag and the next equivalent medication. There are equivalent alternative medications, although these medications have their own drawbacks, being off label, intramuscular injectable or increased doses per day. Also, on August 25, 2014 it was announced that a generic for Moxatag is being produced (Fera, 2014), which will introduce a lower cost once daily alternative. Once this medication is introduced, it may offer a better option than the current alternatives to Moxatag. For the time being, however, I believe that with good prescribing practices, these current alternatives are effective and significantly less expensive, which make Moxatag unnecessary to prescribe.

The FDA plays a very prominent role in everyone’s lives whether people realize it or not. The role of the Food and Drug Administration is to put regulations in place in order to keep the population safe from disease, like ones that come from contamination of meat in slaughterhouses. The problem of contamination of meat often originates from a lack of cleanliness in slaughterhouses and stockyards, which is something that stockyards and slaughterhouses lacked much of in the book Devil in the White City.

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.

In 2000, the US Food and Drug Administration issued a health claim which states that consuming foods containing plant sterol and stanol esters along with other low cholesterol and saturated fat foods can reduce the risk of coronary heart disease (Jones, Vanstone, Raeini-Sarjaz, & St-Onge, 2003). Today, many functional foods in the form of margarines, spread, yogurt, and others, have been enriched with phytosterols and advocated as being able to reduce the risk of coronary heart disease. Phytosterols have been known for its cholesterol-lowering effect by blocking absorption of cholesterol in the intestines. However, there are controversies surrounding the efficacy of phytosetrol that are enriched in foods in reducing cholesterol levels. Many studies have also demonstrated the efficacy of phytosterol-enriched foods. Vásquez-Trespalacios and Romero-Palacio (2014) and Amundsen, Ose, Nenseter, and Ntanios (2002) have demonstrated the efficacy of phytosterol-enriched foods in reducing total and LDL-cholesterol levels. However, there are also many studies that show otherwise. For example, Jones et al. (2003) and Weingärtner et al. (2016) have shown that phytosterol-supplemented foods did not have any effect on total and LDL-cholesterol levels. The debate regarding the efficacy of phytosterol in functional foods is crucial as phytosterol-enriched foods can potentially be a solution to a continuous increase in population suffering from cardiovascular diseases. The

Today, the U.S contains five percent of the world 's population and it holds twenty-five percent of the world 's prisoners. Approximately one out of every four prisoners on the planet is in a U.S prison. The Drug Enforcement Agency (DEA) makes over 30,000 arrests each year related to the sales and distribution of illegal narcotics. In 1986 the Anti-Drug Abuse act set the 5 and 50 gram quantities for crack cocaine which triggered the five and ten year mandatory minimum jail sentence for crack cocaine. This created a conflict with the ratio from crack to powder cocaine because it was 100:1 meaning a person caught with crack cocaine would be more likely to serve longer jail time than a person caught with powder cocaine. The unfair ratio would get a person caught with 5 grams of crack cocaine the same amount of jail time as a person who is caught with 28 grams of powder cocaine. An issue seen around the country is that people of minority are treated unfair under the law. Not only are people being treated unequally under the law but we are adding to the issue of mass incarceration. The Fair Sentencing Act, which will reduce the amount of people who are sentenced to prison for crack and powder cocaine is beneficial because prisons have become so overcrowded and so many people have been sentenced to jail unfairly and are serving ridiculous sentences for nonviolent drug offenses.

Do you know what you eat every day? What chemicals are approved by the Food and Drug Administration, but are banned or heavily regulated in other countries for health reasons? Most people want to believe they do, but are shocked to find the truth. It has been estimated that seventy five to eighty percent of the foods and drinks sold in stores have been genetically modified (About Genetically Engineered Foods). Genetically modified food, or GMO’s, are a major health risk, and should be clearly labeled by companies, if not banned. My mother is in stage four kidney failure, meaning that she only has about fourteen percent of her kidney function left. She takes about half a dozen medicines a day for pain, hormones, and vitamins. She has been put on a vegan diet, a grain free diet, and was suggested a marine diet. No matter what she tried nothing seemed to help her kidneys or pain. Over the summer of 2013, for fourteen days, my parents, sister, her boyfriend, and I all went to Costa Rica. Costa Rica is a small country in Central America. In Costa Rica, the food was caught fresh, and fruits and vegetables were picked daily in the local garden. After two days being in Costa Rica my mother only had to take two pills for hormones. Her pain dramatically reduced, her migraines went away, and her kidneys could process all the food without problems. She ate meat, fish, bread, and anything she wanted with no side effects. The main difference between the food in the United States and the

Science and Research: The FDA is accountable for overseeing studies to help enhance general welfare by working with the quick fulfillment of the latest governed assets.

On December 1, 2014 the U.S Food and Drug Administration (FDA) established two new rules requiring menu labeling and vending machine labeling. What does this mean exactly, well when it comes to menu labeling any establishment that has 20 or more chains are now required to list the calorie information on their menus or menu boards. This not only includes sit-down restaurants but also drive-through windows and takeout foods. They also established another rule for vending machines which requires all owners or operators with 20 or more vending machines to display calorie information as well. According to the FDA “Americans eat and drink about one-third of their calories away from home. Making calorie information available will help consumers make informed choices for themselves and their families”.

Due to the fact that because drug trials were poorly regulated in the early 1970’s Phase I research was conducted on prisoners. The FDA was granted authority to monitor research that involved humans in the 1978; at which time, the FDA ordered each institution to devise an Institutional Review Board (IRB). The IRB was to generate and monitor the rules of the trials on all studies done within the universality. The IRB was comprised of faculty members who volunteered to evaluate their colleagues’ studies. Unfortunately, before 2005, FDA inspectors’ primary focus was on verifying the clinical trial data, not the human subjects involved in them.

In the FDA, all medicines or innovative products or generic, need to be approved before production would or would become available for patients in every FDA Member State must bear the responsible authority or the FDA, examines and evaluates medicinal products for every market quality, safety and