The FDA hosted a June 5 roundtable discussion with cell and gene therapy experts to gather input on regulatory reforms. Secretary of the Department of Health and Human Services announced that the administration aims to speed up approval processes for new therapies.
Major points from attendees include reducing regulatory barriers, addressing concerns about ceding dominance in the field to China, and exploring genetic engineering for editing pig organs. The proposal involves adopting a two-tier system similar to China’s, where first-in-human trials require only institutional review board approval before FDA involvement.
The discussion highlighted the need for faster and more flexible regulations to support innovation. A recent example is the custom CRISPR gene therapy administered to infant KJ Muldoon, who received treatment in just a few months under relaxed regulatory requirements.
Attendees emphasized the importance of reducing administrative costs and redundancies while fostering innovation. The proposal includes allocating excess funds towards supporting researchers and biotechs developing life-changing therapies.
Source: https://www.fiercebiotech.com/biotech/fda-cell-and-gene-roundtable-makary-rfk