The birth of a new drug takes about 15 years.
STAGE 1 — 6 to 7 Years
Scientists toil away in their laboratories, studying thousands of chemical compounds in the hope of finding one that can fight a particular disease. If one looks promising, it’s tested on animals to see how effective and safe it might be for humans. But it’s survival of the fittest at this stage: Only 5 out of every 10,000 compounds tested, on average, will do well enough to qualify for human trials.
STAGE 2 — 6-7 Years
To test a drug on people, drug companies must perform three levels of clinical trials to see if the drug is:
• Safe: Side effects and dosages are studied in 20 to 100 healthy volunteers.
• Sound: A group of 100 to 500 people with the targeted disease try the drug to see if it actually works.
• Superior: A drug is usually tested on 600 to 3,000 people to see how well it works compared with other treatments or placebo. Just one out of every five drugs will score passing marks during this stage.
STAGE 3 — 6-12 Months
The FDA reviews the scientific data and decides if the drug will be approved. (Most drugs take ten months, fast-tracked drugs about six months.) Once approved, the drug soon hits store or pharmacy shelves.
STAGE 4 — 18 Months
In this phase, the FDA can now require drug companies to review the drug’s safety in the general population after it goes on the market.