In have read and learned much from books by Marty Makary and Vinay Prasad, who are now high officials in the F.D.A. I also have suggested that patient freedom and drug innovation would both be served if the F.D.A. cut back regulations to only regulate for drug safety and leave drug efficacy to the judgement of physicians and patients.
Makary and Prasad have now announced that the F.D.A. will only require one clinical trial to satisfy the Phase 3 stage, instead of the currently common two trials. This is a partial, not a full, step toward my suggestion, but it is a step in the right direction. A modest step is better than no step at all.
I also support their announcement of the increased use of I.A. I believe that will increase efficiency, but doubt that it will soon “radically increase efficiency,” as they claim.
(p. A1) The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday [June 10, 2025] in JAMA.
. . . And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.
“The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.
. . .
(p. A16) For some cases, the F.D.A. officials proposed speeding major drug approvals by requiring only one major study in patients rather than two, a practice the agency has used in recent years. The pandemic provided a precedent, they said, for accelerating the process.
“We believe this is clear demonstration that rapid or instant reviews are possible,” Drs. Makary and Prasad wrote.
. . .
Last week, the agency introduced Elsa, an artificial intelligence large-language model similar to ChatGPT. The F.D.A. said it could be used to prioritize which food or drug facilities to inspect, to describe side effects in drug safety summaries and to perform other basic product-review tasks. The F.D.A. officials wrote that A.I. held the promise to “radically increase efficiency” in examining as many as 500,000 pages submitted for approval decisions.
For the full story see:
(Note: ellipses, and bracketed date, added.)
(Note: the online version of the story has the date June 10, 2024, and has the title “F.D.A. to Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’”)
The JAMA article mentioned above is: