The Health Welfare Of Patients

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

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 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.

Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and

The high prices set by pharmaceutical companies for drugs allows the companies to continue researching, developing, and producing new drugs. As new diseases are discovered, new medications must be discovered in order to treat them.

Currently the U.S. Food and Drug Administration (FDA) is responsible for protecting the over all public health of the United States of America (U.S. Food and Drug Administration, 2015). The FDA protects the “public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” (U.S. Food and Drug Administration, 2015). On the Medical aspect, the FDA is involved by increasing new medical innovation to be more effective, safes, and more

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.

Finally, the increase cost of drugs from pharmaceutical companies are have contributed to the ongoing cost in health care for which the increase in medical technologies are attributed towards. “J.D.Kleinke (2016) reports this medical progress is expensive. In numerous therapeutic areas, better medicines increase costs, at least in the short run; in other areas, better medicines that reduce costs in the short run add costs in the long run. Burton Weisbrod and Craig LaMay summarize this overarching impact of innovation in their observation that “the use of antibiotics to prevent deaths from infections can cause people to live longer and hence to die from heart disease and cancer, which typically entail even greater costs.” Break through drugs

Through the years, the pharmaceutical companies’ and government’s roles in healthcare and regulation has adjusted due to the rapidly changing state of the country. The population of the United States has surged in the past fifteen years with an influx of about thirty-six million citizens, and rapid growth calls for rapid change. Unfortunately, bad habits have become rooted in America’s government practices, lobbying, bribery, and overall sluggish pace due to red tape has hurt the healthcare situation in the country.

Actually the transition from laboratory accomplishment towards human clinical trials has develop into so complicated manners that former NIH Director Elias Zerhouni has designate it the "valley of death. University’s laboratories are examining cells and enzymes and investigate models of human diseases in animals. Usually, after these discoveries, the duty of testing the potential drug in humans is a part of industries. But from the last few years Pharmaceutical companies are focusing on the drug which already passed the regulatory hurdles due to increasing clinical trial cost, expiration of patent and regulatory stringency. New trend has come up that big pharmaceutical companies are willing buy small pharmaceutical company whose research is in final stage and promising the drug approval from the FDA. According to Center Watch, the clinical trial business association, the figure of clinical trials including the United States and worldwide studies, decrease in 2012 compared to previous four years. These developments disturb researchers who have newly identified compounds in the laboratory that they were thinking that it could be effective to treat dengue viruses, west Nile virus, and hepatitis C virus. These new innovative compounds can be drug by exploring a different route i.e. university, industry, and equipped capabilities, Drug improvement Ventures may be able to survive the economic environment by

For example, the drug Thalidomide, which has been used to treat pregnant women in Europe resulted in newborns with missing limbs. But, if the drug would have been clinically tested, approved, and then used, these consequences might have not occurred. So, the idea of the FDA to regulate the new drugs is a good thing as they undergo a series of testing phases prior to full approval (Steiner, 2014). On the other hand, slow implementation of new drugs took the life of a nine year old in the last decade due to shortage in supply of the drug Methotrexate (Roman,

The research and development of the pharmaceutical industry is very important as the industry relies on it to develop new products to maintain and sustain the growth of the industry (ALRC 2014). According to the Australian Government Law Reform Commission, every year, the total spending in research and development in pharmaceutical industry, which includes drug discovery, pre-clinical testing and clinical trials on drugs is around $300 million (ALRC 2014). Mergers and acquisitions are intensifying in the global pharmaceutical industry, especially over the last 10 years. With factors like exorbitant research and development costs, the relatively shorter product life cycles, and the rarity of discovering a new life-changing drug acting as catalysts, leading pharmaceutical companies now have more cause to step out and look for external collaboration. This results in an increasing number of smaller biotechnology companies merging with bigger pharmaceutical companies (The

Although R&D has been retained by the large pharmaceutical firms, there has been a continuous decline in the R&D productivity. Controlling R&D is imperative to the success of a Pharmaceutical firm. However, as the pharmaceutical industry is maturing, there are diminishing returns to the R&D investment. Fewer and fewer blockbuster drugs are being discovered and therefore R&D is not the most value adding component in the value

The European pharmaceutical sector is a EUR multi-billion industry that, not only contributes to the competitiveness of Europe in the world market, but also helps drive its economic growth. With such prominence, there is no surprise to why it is perhaps one of the most heavily regulated sectors in the European Union. The European Commission has taken extensive measures to ensure that dominating pharmaceutical companies are not abusing their dominant position of power. At the same time the Commission has to be able to promote the development of new medicinal products. This has proven to be an arduous task as pharmaceutical companies developing new medicinal drugs have to overcome pervasive and diverse regulations