25 October 2019 - Recent years have brought significant innovation in potentially curative therapies for several diseases. To expedite patient access to these therapies, the U.S. FDA has undertaken progressive efforts to accelerate drug approval. 

For example, the FDA’s Breakthrough Therapy Program, enacted in 2012, has approved nearly 140 breakthrough therapies and shortened novel drug approval times by almost a year. By 2025, the FDA anticipates approving 10 to 20 cell and gene therapy products per year, many of which are intended to be one-time curative treatments.

But despite these efforts to accelerate the evaluation of drug safety and efficacy, uptake of many new therapies has been much slower than expected. Why the lag?

Read Harvard Business Review article