USA – Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation

Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a new formulation, while other factors like clinical effectiveness were not predictive of reformulation, according to a recent study published in JAMA Health Forum.

“This study reinforces concerns that manufacturers are using evergreening strategies to maintain revenue and avoid generic competition,” Ravi Gupta, MD, of the National Clinician Scholars Program at the University of Pennsylvania in Philadelphia, and colleagues wrote in their study. “It suggests that policy makers should consider the role of new formulations more carefully to incentivize therapeutically valuable innovation and minimize strategies to avoid generic competition.”…