Steps that are required to bring a new pharmaceutical to market
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Before drugs are approved by food and drug administration agency (FDA), several pre-clinical tests using animals are done before any test is done on human beings. The tests on animals are done even before the agency scrutinizes clinical trials to determine the side effects and if the manufacturing companies follow the recommended conditions. Pharmaceuticals require about 12 years between the times the drug is discovered to the time it is introduced to the market (Lipsky & Sharp, 2001). The cost for the whole process is usually very high approximating to about $1.8 billion before the new drug is introduced in the market and the success is not guaranteed. The process involves several stages and is risky because statistics indicates that only 0.01% of the pharmaceutical drugs researched reach the market and out of the 0.01%, only about 33% recaptures the cost incurred in their development. The development of any pharmaceutical drug is highly regulated due to the concerns of human health and must follow the three phases namely the pre-clinical research, clinical research and post-marketing phase after the product is placed in the market (Lipsky & Sharp, 2001).
The manufacturing industry first consults the FDA before making an application for the investigation of the new drug (IND). The manufacturing company prepares preclinical results after doing the testing on animals and the propped tests on human. The FDA scrutinizes the results and proposals to determine if it is viable for the tests to be done on humans. The board at FDA comprises of scientists in medical institutions who oversees the research process on introduction of new drugs in the market. The board advises the company on the type of people to be involved in the test and detailed process to be followed. This includes the program, the dosages, the periods, and objectives of the tests (Lipsky & Sharp, 2001). The requirements of the FDA are that the research must be acceptable and the participants must give consent after being informed of the risks associated with the research. The participants should be advised on the right measures they should undertake in case their rights are violated.
The initial step involves healthy volunteers to determine the side effects of the drug such as effects on driving automobiles, performing tasks that require concentration and physiological testing. The step involves between 20 and 80 subjects. If the results of step one do not show unacceptable toxicity the process enters step two to determine the effectiveness of the drug on people with certain conditions. Patients on the drug are compared with patients on a different drug. The step two may involve up to 80 subjects (Lipsky & Sharp, 2001).
Step 2 is followed by step three where the FDA agrees with the company on how to conduct large-scale studies. If the drug is found to be effective in step two the research enters phase three where different population and dosages are used in combination with other drugs. The phase may involve as many as 3000 subjects to establish more details about the safety and effectiveness of the drug. The trials in phase three usually cost the sponsor between $50 and $100 million each (Lipsky & Sharp, 2001). If the FDA approves the drug, the manufacturing company conducts a study to determine the requirements for the marketing of the drug. The FDA uses the information from the study to know more about the safety of the drug (Lipsky & Sharp, 2001).