The Food and Drug Administration Essay - 866 Words

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. 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†¦show more content†¦During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. Phase 2 Clinical Studies - Helps determine the common short-term side effects and risks associated with the drug. Phase 3 clinical studies - Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years. Although the FDA prolongs this process for safety concerns, I personally feel that they should be able to expedite their approval. The reason for expedition is because more and more people are being diagnosed with multiple health issues. Some people are more desperate then others and feel they can benefit from the drug as it is. Therefore, if a person wants to take a drug that has not been approved yet, then they should be able toShow MoreRelatedThe Food And Drug Administration1204 Words   |  5 PagesThe 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 areRead MoreThe Food And Drug Administration Essay848 Words   |  4 PagesThe 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 knownRead MoreThe Food And Drug Administration1017 Words   |  5 Pagescosmetic products on the market all over the world than ever before. There has also been an emphasis on beauty and how one presents themselves to others. The combination of these factors lead to an increase in demand for cosmetics. 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As a world, we are facing an adaptation deficit leaving us very vulnerable and thus, we must seek to find alternative resources to adapt and mitigate the risk to agriculture. One solution might be attributed to genetically modified foods, which are found in 80% of processed foods today, much to the unawareness of public consumers. In America, the Food and Drug Administration has the authority over food la beling and it has concluded that thereRead MoreThe Food And Drug Administration1903 Words   |  8 Pages2016. On December 1, 2014, the US Food and Drug Administration released a Final Rule clarifying the requirements, which include easy-to-see calorie counts for all â€Å"standard menu items,† as well as the inclusion of statements communicating the average daily intake of 2,000 calories and informing consumers that more detailed nutritional information can be obtained by request (Goldman, 2015). The goal of this rule is â€Å"to make nutrition information for certain foods available to consumers in a directRead MoreThe Food And Drug Administration2463 Words   |  10 PagesConsumers thus should be concerned what they put in their bodies. The Food and Drug Administration is regulating food, but people are sicker now than they ever have been. Not only them, but the big pharmaceutical companies also play a role in this giving drugs to people to help their problems but end up with a host of other problems from their fix. With this project I hope to show how incompetent the Food and Drug Administration is by unveiling what synthetic vitamins really are, the chemicals usedRead MoreThe Food And Drug Administration843 Words   |  4 PagesThe Food and Drug Administration (FDA) approved naltrexone in 1994 to assist in the treatment of alcohol dependence (Mark et. al, 2003). According to multiple studies of various sizes the medication has been proven to be highly beneficial in assisting with alcohol withdrawal and relapse (Leavitt, 2002; Rohsenow, 2004; Williams, 2005). With the approval of the FDA and the backing of many studies, why is this wonder drug not being more widely used? The following will address how naltrexone worksRead MoreThe Food And Drug Administration1142 Words   |  5 PagesAndy Nunez English 1101 Amy Sandefur 9 September 2014 Dear Michael Taylor, As senior advisor of the Food and Drug Administration (FDA), I understand that you must have thousand of proposals being addressed to you everyday. I also understand that the FDA is responsible for tests that use dogs, primates and other species as test subjects to meet legal safety requirements. (Navs.org) At the same time, I, and millions of other people believe that the laws on animal experimentation need to be reviewedRead MoreThe Food And Drug Administration1430 Words   |  6 Pagesto the sugary taste of many foods and go by many names – saccharin, aspartame, and sucralose  ¬Ã¢â‚¬â€œ but they are all formulated by chemical engineers. The Food and Drug Administration (FDA) describes artificial sweeteners as â€Å"probably safe,† and this statement has proven to be quite true (Nestle). For several years, aspartame and saccharin have been linked to weight gain and cancer in consumers and lab animals (Nestle). Because artificial sweeteners are used in many food pro ducts (most commonly diet