Drugs can be very expensive, and some people wonder how and why this is. The truth is that developing a new drug and getting it to market stage is a lengthy, complicated, costly process. It can take up to 15 years and half a billion dollars to get a new drug ready to be sold.
For better or worse, drug manufacturers want to recoup the investment they made not only on the successful drugs but also on the ones that never make it to market. Read on to learn more about this process.
Step 1: Drug Discovery
Some drugs, such as penicillin, were discovered by accident but pharmaceutical companies cannot just sit back and hope for more happy accidents. They employ educated (and expensive) researchers to work on developing new medicinal therapies.
High-throughput screening enables researchers to test thousands of different chemical compounds against thousands of possible targets in hopes of identifying a new drug-target interaction. In the rational drug design model, scientists synthesize chemical compounds that are designed to target the known structure of a specific molecule.
Step 2: Pre-Clinical Development
Pre-clinical testing centers around the best ways to develop the target drug for its intended use, such as how the human body reacts to the drug and how the body breaks down and eliminates the drug. Drugs in development may be modified as new information is learned.
In pre-clinical development, researchers also determine the best way to deliver the drug. Options include creams, pills, injections, and sprays. Once the drug has been approved by regulatory authorities, clinical trials can begin.
Step 3: Clinical Trials
In clinical trials, scientists use human volunteers to test the compound being trialed. Clinical trials consist of five phases:
- Phase 0: Effect on body
- Phase I: Safety for humans
- Phase II: Effectiveness at treating targeted disease
- Phase III: Large-scale tests for safety and effectiveness
- Phase IV: Long-term safety of drug in question
When a drug is approved to go to market, regulatory authorities effect a relatively short period of exclusivity in which other pharmaceutical companies cannot make competitive or generic equivalents to the drug. This helps the manufacturers recover some of their sizeable investment in the development of the drug.