Food And Drug Control

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.

For my research on a Federal Agency i chose the Food and Drug Administration (FDA).The reason i decided to choose this is because food and drugs or medication are involved in our daily lives.The Food and Drug Administration is responsible for the safety of the people.They are the main people that we rely on for the safety of good food and medication.The FDA is who allows the medication and food to go out on stores to be sold,they make sure this are safe for use and consumption by the people.

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

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.

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

Graham made a statement saying, “The people who approve the drug in the first place, within the FDA, and take pride in the fact that they’ve brought a drug to the market - that is their baby. This is their drug.” he says this because 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 Pure Food and Drug Act and the Meat Inspection Act are congressional acts that were signed by President Teddy Roosevelt on June 30, 1906 in an effort to prevent the adulteration and misbranding of products distributed. During the eighteenth and nineteenth centuries, America was in the process of transforming from an agrarian society to an industrial economy which became known as the Progressive Era. During this period, meatpacking industries and food corporations were run by corrupt business owners who overworked employees in unsanitary conditions, and had no regulation of how the food was processed. As a result of the high demand for food in the United States, food industries were under the impression of mass producing goods to create

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

Food code is something that authorities write or adopt that regulates retail and foodservices operations, but these codes can differ from the FDA Food Code, because the agencies are not required to adopt them. Most food codes are different only because it can be different in one state or another or because of locality. The FDA was doing the food code every 2 years, but then the FDA decided that they wanted to move it to every 4 years in between the food code editions. Meanwhile between the periods of the full editions, the FDA may publish new updates, modifies, or clarifies certain things. FDA is the agencies that oversights the food code, they are the ones who encourage you to adopt a food code so you can help reduce the risk of foodborne

The first law that was passed was the Pure food and drug act of 1906. This law was passed to protect the public from adulterated food products does meet federal or state standards. The pure food and drug act was amended 3 times, once in 1912, again in 1913 and on last time in 1923. The muckrakers finally successfully made it finally with public awareness with food safety and drug addiction. In 1906 President Theodore Roosevelt began the journey for the Mean Inspection Act which was shortly followed by the Food and Drug

To understand when, how and who began the Food and Drug Administration, one must trace it back to 1848 and to a man named Lewis Caleb Beck. In 1848, Beck was appointed to the Patent Office, to perform chemical analyses of agricultural products; later this function was passed on to the Department of Agriculture in 1862, which was the beginning of the Bureau of Chemistry, the predecessor of the Food and Drug Administration. In 1930, the Bureau of Chemistry changed its name to FDA, and today it serves under the Department of Health and Human Services. In 1883, Dr. Harvey W. Wiley became the chief chemist at the Bureau and he immediately increased the food adulteration studies; which was the beginning of an uphill battle for law changes in the

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.

Before any biopharmaceutical company can begin to manufacture a desired product, the company is required by law to establish an adequate facility to support a safe and efficient manufacturing process. The US Food and Drug Administration (FDA) department under the authority of the Federal Food, Drug, and Cosmetic Act determines whether or not a specific manufacturing facility is approved. Furthermore, companies must adhere to the Good Manufacturing Practice Regulations (GMP) specifically those described in ICH Q7 in order to effectively fulfill FDA requirements. The fundamental purpose of the regulations beforehand is to accomplish a system that ensures products are consistently produced and controlled to the highest standards and thus prevent human safety risks that may not be reduced through testing the final

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.