Biotech Leaders Concerned About FDA Uncertainty
Biotech leaders are expressing concerns that uncertainty at the FDA is threatening drug development.
The recent rejections of Replimune and Capricor therapies by the FDA have highlighted the issue of instability at the agency.
“It is going to kill drug development if you don’t have consistency and transparency,” said Replimune CEO Sushil Patel. “It’s really going to make it very difficult for us to bring innovative treatments to patients faster.”
Replimune Group and Capricor Therapeutics had both been on track to receive drug approvals from the FDA earlier this year, but their applications were rejected amid changes at the agency following the Trump administration's takeover.
The CEOs of the companies discussed the importance of a stable FDA at the STAT Summit, emphasizing the need for consistency and transparency in the agency's decision-making process.
Author's summary: FDA uncertainty threatens biotech innovation.