FDA commissioner talks of shortening drug approval process, benefits of AI

Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval process and the use of artificial intelligence, among other topics, during the AHA Annual Membership Meeting.

“We at the FDA now have to ask big questions that we’ve never asked before,” Makary said. “Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things?”

Makary said the FDA completed its first AI-assisted scientific review for a product this week, with hopes of implementing the process agency-wide by this summer — and eventually using it to help shorten the time for drug approvals.

Makary was also optimistic about AI helping with the approval of new treatments for conditions such as diabetes and certain types of cancer.