Pharmaceutical products Essay Example

Preposterous costs of Biotech/ Pharmaceutical products Essay Example Preposterous costs of Biotech/ Pharmaceutical products Paper Preposterous costs of Biotech/ Pharmaceutical products Paper Biotech / Pharmaceutical companies incur huge costs in brining a drug to the market. This paper details the process of drug development right from the stage of preclinical trials to the final stage when the drug gets FDA approval. The paper gives an insight about the costs incurred by the companies in the drug development process. Considering the specific example of Genentechs controversial anti-cancer drug Avastin, its cost is compared with the value it delivers to its customer (a person suffering from cancer). Drug development is a very costly affair which involves high risks. Though the risks in the process of drug development overweigh the benefits, the drug manufacturers are motivated to undertake such a process because of the current patent laws which promise a good reward for a comparatively good product. Moreover, the very survival of many of the pharmaceutical companies world over depend to a large extent on the new products coming out of their pipeline. Thus pharmaceutical companies world over invest billions of dollars every year in the development of new drugs. No doubt they try to get back the money that they invest from their customers. The success rate of developing a new drug is shockingly low. Not every drug tested in the laboratory is launched in the market. A drug has to undergo several stages of development before it is successfully launched in the market. A company has to screen through many thousand compounds that show promising result before it could take on the task of development of a promising compound. This eventually increases the cost of development of drug as many compounds that are tested are discarded in the preliminary stages of development. For every 1,000 compounds that are identified by a company, only about 30 show promising results. And for every 30 compounds that show promise, three get past the first round of clinical trials and finally, only one hit the market. Sometimes compounds are to be dropped off during regulatory approval process. Thus, to introduce one new drug, a company needs to start with many thousands of compounds. (Janodia, Manthan 2007) The process of drug development is a very slow one and it is scrutinized at every stage by the FDA. According to PhRMA (Pharmaceutical Research and Manufacturers of America), on an average it takes around 12 to 15 years to develop a new drug. This crawling rate of drug development can be attributed to the numerous stages that are involved in the process of drug development. Even before the drug is tested on humans, it needs to undergo the process of preclinical testing where it is tested on animals. The different phases of preclinical testing preceded by drug discovery consume around 6.5 years. The three phases of clinical trials (before the market launch and FDA approval) require around 7 years. It would take around one and a half years to assess the safety of the drug on healthy volunteers in phase I trials. The effectiveness of the drug needs to be proved in the phase II trials which consumes around 2 years. To confirm the pharmacological actions of the drug and also its effects on long term use need to be studied on a few thousands of humans which requires around three and a half years. Further, one and a half years of post marketing clinical data analysis needs to be done before the FDA approval for the drug could be obtained successfully. Let us now have a look at the different stages of the drug development process.