It may surprise you to learn that many of the drugs coming into the market this year were just a gleam in a scientist’s eye 15 years ago. The development of a medication requires patience, dedication and determination.
It takes an average of 10 – 15 years for a pharmaceutical patent to be approved by the
Food and Drug Administration (FDA) for public use. There are five main phases in the development of a drug from an idea to your medicine cabinet:
1. Drug Discovery – When members of the medical community discover a new disease or recognize the need for a new pharmaceutical treatment, they join with researchers from government, academia and technology in attempting to isolate the root causes of the problem before ever entering a laboratory. After they have a solid understanding of the illness, scientists examine thousands of chemical compounds to discover those that have a scientific impact. Eventually, they narrow it down to approximately 250 compounds for testing in the preclinical stage.
2. Preclinical – The compounds that make it past the discovery stage then undergo a series of lab and animal testing to ensure they are safe to be tested on humans. Of the 250 compounds that enter preclinical testing, only one to five successfully advance to the next stage. The preclinical phase can take three to six years.
3. Clinical Trials – Once a chemical compound makes it to this stage, it is referred to as a candidate drug. During clinical trials, candidate drugs go through several rounds of testing on humans. These trials can take up to six or seven years to complete. Approximately 90% of drugs that are tested in clinical trials fail or do not work as intended.
4. FDA Review – If a candidate drug passes the discovery, preclinical and clinical trial stages, the pharmaceutical company that sponsors it documents their findings in a New Drug Application (NDA) for the FDA to review. NDAs can run up to 100,000 pages! Understandably, this stage can take up to two years to complete.
5. Large-Scale Manufacturing – Finally, after a decade or more of study, testing and review, a successful medication receives the FDA’s seal of approval to be produced for public distribution. 10 to 15 years after the idea was first conceived, the drug ends up in your medicine cabinet.
Once a medication has been made available to the public, the FDA will continue to monitor its performance to ensure there are no unexpected adverse effects.
This long process results in quality pharmaceutical drugs. Approximately 97% of the medications approved by the FDA in the past 20 years are still available in your neighborhood pharmacy, to be joined in a decade or so by something that is only an idea today.