Food And Drug Administration : Big Pharmaceutical

The pharmaceutical industry is one of the most powerful and greedy industries in our country, with a goal to make as large a profit as possible, at the expense of the sick.

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.

"In the past two decades or so, health care has been commercialized as never before, and professionalism in medicine seems to be giving way to entrepreneurialism," commented Arnold S. Relman, professor of medicine and social medicine at Harvard Medical School (Wekesser 66). This statement may have a great deal of bearing on reality. The tangled knot of insurers, physicians, drug companies, and hospitals that we call our health system are not as unselfish and focused on the patients' needs as people would like to think. Pharmaceutical companies are particularly ruthless, many of them spending millions of dollars per year to convince doctors to prescribe their drugs and to convince consumers that their specific brand of drug is needed in

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

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.

U.S. based companies hold rights to most of the world’s rights on new medicines and holds thousands of new products currently being developed. As of 2012, the industry helps support almost 3.4 million jobs in the U.S. economy. It is also one of the most heavily R&D based industries in the world. In the United States, the environment for pharmaceuticals is much friendlier than other countries around the world in terms of pricing ability and regulations. Both the Pharmaceutical and Biotechnology industries have experienced significant growth in the past year with year-over-year increases of 13.02% and 34.69% respectively. It is an even more striking when looking at the past five years considering both have beat out the S&P 500 with pharmaceuticals increasing an additional 31.44% and the biotechnology sector besting an astonishing 269.3% more return than the

Bell continued to interview a journalist named Greg Critser, who authored the book “Generation RX,” which is about the relationship between America and pharmaceuticals. He exclaims that drug companies advertise their product so much that it internalizes inside individuals that the drugs they’re selling are good and not poison, then he continued where the drug is somewhat of a poison where it kills another thing off to benefit another. Pharmaceutical companies also lobby the political side of their ambitions to cover up the negative side of their

Commercialized on TV as the only solution to our numerous problems, Big Pharma preys on people who struggle through life. Although seemingly meant to heal, pharmaceutical drugs have destroyed countless American lives instead because gullible patients rush to their doctor demanding prescriptions. Want to lose weight? Give me a pill. Want more intense sexual encounters? I need a pill. Want to grow longer, shinier hair? Hey, I’ll just pop a pill. Although some medical conditions do require medication, not every case of discomfort should be treated with highly addictive prescription meds nor should those drugs be trafficked via commercials that target a hypochondriacal nation of couch potatoes too lazy to put forth the time and effort to prevent disease. Instead, far too many Americans simply find a quick fix at their local pharmacy. These prescriptions lead to addiction and in the end death. Therefore, if I could take away any one invention from mankind it would be the crass commercialization of pharmaceuticals.

We in America tend to take medications for almost any problem we have, from headaches to gastrointestinal pain, to more serious chronic disorders such as depression and attention deficit disorder. While many of the uses of such medications may be necessary and legitimate, many are not, and due to this fact, many people become dependent on medications, mentally, and or physically. This problem is not simply the fault of the individual; in fact, the blame can also be placed upon the medical community, and the pharmaceutical companies who produce the drugs. How often can one turn on the television to see advertisements for Claritin, Aspirin, Pepto-Bismol, or even Zoloft or Ritalin? The pharmaceutical industry is motivated by monetary

Tegan Dalton Ms. Gibbons English Senior Thesis 11 December 2017 The Prescription for Society The biggest problem within the realm of pharmaceuticals themselves is the belief held by people that prescription drugs are not dangerous. In order to understand the use and abuse of prescription drugs, the observations of commercializing and glorifying the industry must be taken into account to realize why they are harmful to society as a whole. According to the National Institute of Drug Abuse, “Misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking somebody else’s prescription even if, for a legitimate medical complaint, such as pain; or taking a medication to feel euphoria.” This problem is complex

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.

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.

Recently, there has been a debate about the high prescription drug prices in the United States. Accounting for 9.7% of the national health expenditure, $329.2 billion was spent on prescription medications ($931 per person) in 2011 (Linton, 2014). So what exactly is the average American getting with their $931? Well, because there is an extraordinary amount of time, effort, and energy that goes into creating, manufacturing, and distributing a new drug, it’s no wonder the prices are so high. But what other costs are folded into the prices of your prescribed medications? This review looks beyond just the research and development costs needed to take a new drug from idea to shelf by examining several journals and other credible, secondary sources, to shed some light on how much pharmaceutical companies are spending to develop, advertise, and sell their drugs.

The Food and Drug Administration (FDA) audits clinical-trial information for new medications and figures out if the advantages of these medications exceed the risks.1 This necessity, enacted in 1962,2raised the bar to regard and diminished the probability that new medications would be inadequate or reason significant wellbeing issues. Growing such information about investigational medications requires some serious energy for the evaluation of items that at last end up being sheltered and compelling. Such a period slack can be an issue if elective medications for the condition are not accessible. The FDA hence added to an arrangement of extended access to allow patients with genuine conditions to get investigational medications before formal

Even though the pharmaceutical industry has made great improvements to human health and quality of life, like creating drugs for the treatment of AIDS, cancer, and other diseases, an increasing tension is growing between the public and the industry. These thoughts are fueled by issues such as drug pricing, affordable health care, and the battle against epidemic diseases in third world countries; social critics wonder whether this multi-billion dollar industry is giving enough back to the community and fulfilling its social responsibility.