Millions and millions of people take prescription drugs every day, but few actually think about where they come from or the steps that it takes to make these medicines available. There are four steps in the development of pharmaceuticals; these include three initial phases and finally an approval by the FDA. The entire process takes between eight to 12 years.
1. Preclinical Phase
In the preclinical phase, the goal is to find an agent that can be used to treat a certain disease or condition. This involves three to four years of research, the synthesizing of compounds, the testing of those compounds in a non-clinical setting with the help of companies like Nelson Laboratories, and, often, computer simulations on how the new investigational drug may help to slow the progression of a disease or treat its symptoms.
2. Application to the FDA for Investigational Drug
If the preclinical phase is deemed successful, meaning that the compound is promising and shows an ability to treat a disease or ailment, then an application to the FDA as a new investigational drug is in order. The time it takes for the FDA to approve or deny the investigational drug trials varies, but may take up to a year.
3. Clinical Phases 1, 2 and 3
There are three clinical phases for all investigational drugs, and they must be tested on animals prior to their introduction to the human population. After animal (usually rodent) testing is completed, the three clinical phases for humans include:
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Phase 1 – Investigational drug is given in small doses to volunteers who are healthy in order to test its pharmacology and safety.
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Phase 2 – The efficacy of the investigational drug is studied. This involves a clinical trial with 100 to 300 patients who have the condition that the drug is designed to treat.
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Phase 3 – The drug is given to a larger population in an attempt to back up safety and efficacy findings and to titrate the right dosage.
These phases take one, two and three years, respectively. It should be mentioned that nearly half of the medications submitted to the FDA for investigational drugs will fail in the clinical phases.
4. New Drug Application with FDA
Finally, if the drug passes through all of the clinical phases, the manufacturer will submit an application for a new drug. The FDA will complete its own review at this point, and since 1992, the FDA has worked to complete these reviews in 12 months or less. Sometimes, drugs are denied; in other cases, the drugs may be approved conditionally. The manufacturer is required to keep track of results for the first three years after approval and report adverse reactions quarterly.
Because of the processes involved in developing new drugs and getting them approved through the FDA, these medications can often be quite expensive. A vast amount of research and testing must be done long before these drugs are available to consumers.
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