A great deal of time, money and research go into the development of a new drug and many of these drugs won’t even make it to the destined patient until it’s too late. Imagine having to tell someone with a life-threatening disease that there is a possible cure but it happens to be in the experimental phases of development, and they don’t qualify for the clinical trial. “It is estimated that, in 2006, nearly 1.4 million ’terminally ill’ patients in the United States lost their battle, many having been denied access to potentially lifesaving treatments” (Portell, 2008) Drug sponsors and manufacturers monitor the results of all stages of the development process to ensure that the drug is safe for general use. However, giving experimental drugs to patients before they are approved leaves room for erroneous trial outcomes and results in higher time and money costs for the manufacturers. Drug sponsors have many steps to complete; applications to fill out, reviews to attend and clinical trials to perform, all while maintaining the ethical and legal standards set forth by the United States. “According to the Pharmaceutical Research and Manufacturers of America, the average drug on the market is the end result of 15 years of research and development from the earliest stages of drug discovery to FDA approval.” (DeArment, 2009) In order to get a clear picture of how to obtain drugs while still in the experimental phase an in-depth look at the developmental and approval process is needed. As well as an understanding of who is liable if the drug causes an adverse effect in these individuals. This report will also examine a group designed to help the terminally ill obtain these drugs. Patients who have a terminal illness are most often eager to try anything, including unapproved drugs or therapies because conventional medicine has offered little or no help. With all the many requirements and numerous years needed to get new drugs on the market, should patients have experimental drugs readily available for use before the FDA has given their approval? The Drug Development Process
The drug approval process is a long arduous journey, “In order to get governmental approval for new drugs, applicants must meet the safety and effectiveness standards established under the federal Food, Drug and Cosmetic Act of 1938 (FDCA), which requires “substantial evidence” of safety and efficacy prior to approval.” (2003) According to the FDA, they estimate that “it takes approximately eight-and-a-half years to study and test a new drug before it can be approved.” (1998) The purpose of Pre-Clinical research is to gather enough data to prove that it is reasonably safe to test the drug on humans. During the pre-clinical development the FDA requires that a sponsor submit data demonstrating the drug to be reasonably safe for individuals to use in small-scale clinical studies. (1998, p. 5) The data submitted would include the “drug’s toxic and pharmacologic effects”, “Genotoxicity screening” (1998, p. 5) and other technical information. Synthesis and Purification
All new drug research must start with a complete understanding of the human body and how it functions. Researchers have to be aware of the normal functionalities of a body as well as the abnormal ones, in order to understand how a drug will function within those confines. In the synthesis and purification phase of the pre-clinical research scientists usually have to screen hundreds, sometimes thousands of compounds which are added one at a time to other substances in order to find which addition demonstrates some kind of effect. (1998) Another method is to test compounds that are made naturally by microscopic organisms like fungi, and molds. Sometimes, 100,000 or more are tested to see if any give a desirable effect. (1998) Animal Testing
There are two types of animal testing, short-term testing which ranges from 2 weeks to 3 months and long-term testing which range...