In 2012, the United States Congress approved a new provision to the Food and Drug Administration (FDA) Safety and Innovation Act, creating a new “Breakthrough Therapy designation.” This new designation aims to shorten the development and review times for new therapies intended to treat serious or life-threatening conditions, without compromising safety and efficacy standards.
Breakthrough Therapy designation is one of four expedited programs established by the FDA in recent years to help ensure that therapies for serious conditions are approved and available to patients as soon as possible. These programs reflect growing focus within the pharmaceutical industry on the development of treatments for serious diseases.
Nearly 250 requests for Breakthrough Therapy designation were received by the FDA between 2015 and 2017. FDA granted 68 of those requests – and 12 of those products have since been approved by FDA, constituting about 22% of all FDA-approved drugs within that time period.
If you’re interested in pursuing a Breakthrough Therapy designation for your product, here are some of the basics you’ll need to know.