What should I ask FDA Commissioner Robert Califf?

Early this coming week, I’ll be conducting a video Q&A with FDA Commissioner Robert Califf for MedPage Today which will be cross-posted here on Inside Medicine.

As readers of Inside Medicine, I want to know what issues you’d like to hear Dr. Califf address. I’ll consider asking any question that I get from readers via email, or see on Twitter, Facebook, or Instagram, but I’ll be able to give closer consideration to premium subscribers who leave their questions in the Comments section below.

Here’s some information about Dr. Califf from the FDA’s website: Robert M. Califf, M.D., is Commissioner of Food and Drugs. President Joe Biden nominated Dr. Califf to head the U.S. Food and Drug Administration and Dr. Califf was sworn in on February 17, 2022. Previously, Dr. Califf served as Commissioner of Food and Drugs from February 2016 to January 2017. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. Dr. Califf served as the FDA’s Deputy Commissioner for Medical Products and Tobacco from February 2015 until his first appointment as Commissioner in February 2016.

Below is a sneak preview of some of the questions I’m considering asking Dr. Califf, and the Comment section below where you can float your ideas and see what others in the community have suggested.

• What are some of your top priorities for the FDA now? 

• As Commissioner, what kind of authority do you have to enact those priorities?

• How is FDA preparing for the end of the COVID-19 Public Health Emergency (PHE)?

• How will the Emergency Use Authorization be affected by the end of the PHE? If a new drug comes along for Long Covid, for example, will the EUA pathway be available for it?

• What additional data would FDA like to see on the following COVID-related issues?: 1)Vaccines; 2) Paxlovid and other anti-virals; 3) Testing (particularly rapid tests).

• Do you have plans to change anything related to FDA's advisory committees? Can you think of a time when the FDA Commissioner should have overridden an advisory committee vote but did not? Or vice versa?

• The FDA is supposed to be apolitical. But is it fair to say that a Biden FDA would react differently to judicial action over a drug like mifepristone compared to a Trump FDA? If so, what is the public to make of that?

• There has been talk of an "Operation Warp Speed" for rare diseases. Can you talk about the need here and how these initiatives will be funded?

• The FDA's accelerated approval pathway has had its share of controversy, most recently with the Alzheimer's drug Aducanumab. Is the FDA changing its approach in response to recent concerns over the us of this pathway?

• Can approval of drugs that failed to achieve the primary goals of studies (studies carried out by industry with a substantial financial interest in a positive result, no less) really be justified?