Pharmaceutical Innovation

Thesis Statement

The government regulations are holding back pharmaceutical innovation and more lives are being at stake with so many drastic restrictions

Background

Working in the pharmaceutical industry for over 4 years , and more precisely in clinical research, I became aware of how difficult and frustrating can be the ideal of saving lives. As a health care professional I'm inspired to look for more answers in how to deal with our government regulations, and develop my knowledge in the world of regulatory affairs.

Therefore, I have decided to research furthermore all the aspects of the regulatory affairs in US and Europe. Yet, I intend to explore 3 major points: First, the ethical principles and the marketing of prescriptions drugs. Second, medicine and market: equity vs. choices; discuss the promises of the ever-rising life expectation as technology advances. This has forced up both costs and expectations, placing increasing twist on the health systems of high income countries and enhancing the challenge for developing nations. Lastly, pharmaceutical price regulations versus Medicaid-limits, discuss the management of health care costs and expenditure on prescription drugs. After finishing this paper I look forward to have a more positive professional attitude and understanding towards to government drug regulations.

The topic chosen is very broad and turns out that my research in libraries and online will be based on many articles founded in catalogs at Kean and at my company's library.

Discussion

The pharmaceutical industry is one of the most important and powerful industries in the world, with global sales of pharmaceuticals expected to reach some $700 billion in 2007. In affluent societies, pharmaceutical treatment is now the main form of medical intervention for the majority of illnesses and most people take many prescribed medicines over the course of their lives, with pill use typically increasing markedly by the time individuals are aged 60 or over.

The Pharmaceutical Industry is heavily regulated, but due to its research nature it is characterized by changing systems, procedures and new technology. In many cases such legislation has significant impact on pharmaceutical organizations in relation to resources and working practices. Clinical trials, a necessary part of the drug development and approval process, are regulated through their compliance with the International Conference on Harmonization: Good Clinical Practice. Commonly referred to as GCP, it is the accepted quality-associated standard relating specifically to trial conduct including study design, analysis and reporting. It was originally intended as a set of guidelines to harmonize standards between the three main pharmaceutical regulatory regions of the United States. Drug development is expensive and time consuming, costing between $500-$700 million and taking seven to 12 years to bring one new drug to market. Therefore, GCP compliance ensures that the data produced as a result of the research is acceptable to all national regulatory authorities. Currently only a “guideline”, GCP will soon become law in the United States through the American Clinical Trials Directive. First published in 2001, the Directive specifies that each State should draft and finalize an interpretation by May 2003 in order ...