The Pharmaceutical Industry Has Been Privatized

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.

"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

The current system is inefficient, inequitable and unsustainable in the long run because: (1) it is unable to accommodate for the entire Canadian population; (2) it requires Canadians to pay a disproportionate amount of their income to access medications; and (3) governments are unable to contain the drug cost increases (5). Therefore two recommended reforms are described in order to achieve the goal of accessibility and equity.

Product liability laws allow drug users to sue the manufacture, not the FDA, for any adverse drug reactions and side effects. While the FDA oversees drug safety, they do not ensure it. To avoid the costs associated with lawsuits and the risk of a bad name, drug companies do their best to fully, sometimes overly test products before release. “When product liability law attempts to ensure safety already assured by the FDA, prices may be inefficiently high due to liability costs that do not deter manufacturers from producing unsafe products” (Philipson & Sun, 2008, p. 86).

In the video Escape Fire, I was so flabbergasted by the numbers and health outcomes we as a society have let our nation become. One of the most heart-wrenching evidence is, even though our health care industry is so expensive our health outcomes are the worse. 75% of disabilities and dead’s are preventable, according to the film.

Introduction: Since 2001, compounded drugs have caused more than 1,000 illnesses, and 87 deaths in the United States (cite 1). All of these unfortunate incidents were caused by errors during the manufacturing of compounded drugs, and in most cases, because of contamination. On the 25th of September 2013, the Drug Quality and Security Act, also known as H.R. 3204, was introduced, and three days later, was passed by the House of Representatives. On the 18th of November, this Act cleared the Senate. On the 27th of September, 2013, President Barack Obama signed the Drug Quality and Security Act into law (cite 2).

research. (Grounder, 2013) Today pharmaceutical companies are held to a very high safety standard when it comes to marketing

Market failure appears when there is a failure in allocation of goods and services. When the market is unsuccessful, the government is called to intervene and correct the failure. Over the years, government participation in the pharmaceutical market has been more wide-ranging than any other good or service. With the government’s ability to regulate, mandate, inform, finance and provide, their intervention to overcome market failure can be beneficial for the economy. Market failure plays a significant role in today’s economy.

Drug mishaps initially happen to be of critics and detractors of all patients. Pharmaceutical errors and mistakes are preventable episodes that happen because of a blunder during the time spent endorsing, administering, and administrating. Extreme cases frequently prompt negligence claims. The danger variables for drug blunders is talked around and also proposed systems to control them. In the coming of innovation, the medicine organization environment is

To better understand the issues associated with the prescription drug industry, it would first be best to understand their development and approval process. For a new drug to enter the market, it must first undergo a lengthy and often expensive research and development. Once a company submits an application for a new drug, it is their responsibility to provide the evidence showing its safety and effectiveness. Until they have undergone these criteria of guidelines and standards set in place, they will not receive FDA approval.

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

agencies and the pharmaceutical industry” (Armitage, G., & Knapman, H. 2003 ).This paper shall discuss the various causes of, and methods for the prevention of medical errors. In looking at this

The purpose of this paper is to identify a quality safety issue. I will summarize the impact that this issue has on health care delivery. In addition, I will identify quality improvement strategies. Finally, I will share a plan to effectively implement this quality improvement strategy.

Yes, there is an impact on the pharmaceutical company, like those in the US as a result of differential prices between that country and other nations.

A contract manufacturing company has been analysing a tablet product by the method described in the British Pharmacopoeia (BP) monograph. This is the method detailed on the product License and BP methods are generally considered to be validated. After trend analysis for the annual Product Quality Review (PQR) report, it has been discovered that 5 batches were rejected in 2013 due to high out of specification assay results. Furthermore, several batches had assay values close to the upper specification limit. The release specification limits for the product are 95-105%.