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# Do Postmarket Studies Need Public Funds?: Califf
- URL: https://www.fdaweb.com/do-postmarket-studies-need-public-funds-califf/
- Published: 2023-11-21T12:00:00.000Z
- Updated: 2026-09-14T14:16:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Drugs, Devices, #legacy-id-D5155833

FDA commissioner **Robert Califf** says some postmarketing evidence-generating studies are so important that they may need public funding to ensure they get completed. Speaking in a Yahoo! Finance video [interview](https://www.youtube.com/watch?v=iSjpzSUB85Y&ref=fdaweb.com), Califf says he prefers to consider postmarketing evidence-generation as a way of looking forward rather than looking back.

While there are robust approval trials for drugs and medical devices, he said, there is no equivalent evidence-generation system after approval, even though many questions about a product can still remain.

Califf said regulation of postmarketing studies often is not in the agency’s control and that’s why FDA is pushing for the development of a comprehensive system that involves it and other agencies.

Asked about artificial intelligence (AI), Califf said FDA has a “pretty good regulatory scheme” for AI that is used to make predictions, although improvement is needed for the postmarketing phase. However, he said, regulators still don’t know how to regulate generative artificial intelligence. “It’s so explosive and potentially helpful and potentially dangerous,” he said.

Asked about the coming retirement of principal deputy commissioner **Janet Woodcock**, Califf said the agency has known for some time that this was coming and has developed a plan to cover the many roles she played. “Janet has done more at FDA than you could imagine,” he said, noting that she has been closely involved in developing the succession plan and concluding that “we will really miss her.”