FDA: Center for Drug Evaluation and Research (CDER)
And Over-the-counter Weight Loss Medications
Obesity is one of the most serious epidemics facing the American public. "Over two-thirds of adults in the United States are overweight or obese, and over one-third are obese" (Overweight and obesity statistics, 2012, WIN). To address concerns about obesity, many adults turn to over-the-counter medications like dietary supplements that promise the user easy weight loss. The medications usually claim to increase metabolism and suppress appetite, while some also claim to inhibit the absorption of carbohydrates and calories. According to a recent study: "an estimated 15.2% of adults (women 20.6%, men 9.7%) had ever used a weight-loss supplement and 8.7% had past year use (women 11.3%, men 6.0%); highest use was among women aged 18 to 34 years (16.7%)" (Blanck et al. 2007). The FDA has tried to prevent the use of weight loss supplements with tainted ingredients and those which make misleading claims. However, from a legal standpoint, it is more difficult to regulate the natural supplement industry, versus prescribed medications that must pass through rigorous safety and purity screening.
"FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering 'conventional' foods and drug products... Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed" (Dietary supplements, 2012, FDA). The FDA monitors truthfulness as well as safety regarding claims made by supplement manufacturers. However, a natural supplement does not have to pass through different phases of clinical trials to win approval, like a prescription drug....
Divisions of the FDA The FDA is in charge of the regulation of pharmaceutical drugs and medical devices, as part of its mandate to safeguard the U.S. health care system. One unit for this is the Center for Devices and Radiological Health (CDRH), which approves medical devices. The unit that approves drugs is the Center for Drug Evaluation and Research (CDER). There is also the Center for Biologics Evaluation and Research
Phase II consists of efficacy trials of the drug, which are tested on volunteers of the target population. When everything goes right, the drug manufacturer discusses the development process, continued human testing, other concerns and protocols for phase III with the FDA. Phase III is the more extensive. It is at this time that the manufacture can work for the accelerated development and review of the drug. Treatment IND
Health Science in Regards to Drugs and Alcohol Legalization of drugs When Colorado and Washington legalized the use of marijuana for recreational purposes, issues related to legalization of all drugs became subject of public debate. Those who voted for legalization of Marijuana in these two states argued that legalization of these drugs would generate revenue, deter black market activities, and check against lose of tax resources used by law enforcement agencies (Will,
Rats are commonly used for their size (creating the animal-sized scanners is so expensive they are commonly not used in veterinary medicine even for dogs and cats) and the fact that rats breed quickly (PET, 2011, New World Encyclopedia). Lab rats have also been bred to ensure that they have similar enough genetic profiles to the humans the drugs will eventually be used upon, and even more specific populations
Direct to Consumer Advertising HISTORY OF DRUG ADVERTISING THE DTC ADVERTISING PHENOMENON CREATING DEMAND DECEPTIVE ADVERTISING - A WOLF IN SHEEP'S CLOTHING CAUSE OF DEATH PROFIT UTILIZATION, PRICING, AND DEMOGRAPHICS LEGISLATION, POLITICS AND PATENTS LEGISLATIVE INITIATIVES REGARDING DTC RECALLED and/or DEADLY DRUGS In order to provide the most efficient method of evaluation, the study will utilize existing stores of qualitative and quantitative data from reliable sources, such as U.S. Government statistical references, University studies, and the studies and publications of non-profit
Drug Development (From Nature to the Market) The process of drug development is a complex one. The pharmaceutical industry is required to adhere to strict governmental regulations, set out by the Food and Drug Administration (FDA), which involve numerous phases of testing and clinical trials, close monitoring of the drug's effects on users, its stability, dosage forms (the preparation), and so on. This paper will describe the drug development process,
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