Biotech Leaders Express Concern Over FDA Uncertainty
Biotech CEOs are warning that uncertainty at the FDA is threatening drug development, citing recent rejections of therapies from Replimune and Capricor.
Replimune Group and Capricor Therapeutics had their drug applications rejected by the FDA earlier this year, despite initially appearing on track for approval.
“It is going to kill drug development if you don’t have consistency and transparency,” said Replimune CEO Sushil Patel.
Patel emphasized the importance of a stable FDA, stating that instability will make it difficult to bring innovative treatments to patients faster.
The CEOs discussed the issue at the STAT Summit, highlighting the need for consistency and transparency at the FDA.
Author's summary: FDA uncertainty threatens biotech innovation.