The Long Path of Drug Development and Approval

The Long Path of Drug Development and Approval

12.20.12 | By Stephanie Fischer

A new Food and Drug Administration (FDA) infographic may help patients and their families better understand the lengthy drug development and review process, which is somewhat complicated and has many steps to ensure safety and efficacy.

The infographic shows how a potential medicine is first tested in animals before the drug sponsor and the FDA develop a plan to test it in humans in three phases of clinical trials to evaluate effectiveness, safety and side effects.

Even after a new medicine reaches the market, companies and the FDA continue to monitor its safety in the broader patient population and over a longer period of time than the pre-approval studies.

What you may not realize when looking at the infographic is just how long drug development takes. It takes an average of 10-15 years for a potential new medicine to go from the lab to patients. Clinical trials account for seven of those years and 45 to 75 percent of the $1.2 billion average cost of developing one new cutting-edge medicine.

To learn more about the drug development process, please visit PhRMA's resource page or watch this video. You can learn more about clinical trials, including the biopharmaceutical industry's commitment to patient safety and transparency, here.

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