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# Califf Nomination Heads to Senate HELP Hearing
- URL: https://www.fdaweb.com/califf-nomination-heads-to-senate-help-hearing/
- Published: 2021-12-07T12:00:00.000Z
- Updated: 2026-09-14T17:24:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150716

The Senate Health, Education, Labor & Pensions Committee has [announced a 12/14 hearing ](https://www.help.senate.gov/hearings/nomination-of-dr-robert-califf-to-be-commissioner-of-food-and-drugs-food-and-drug-administration-department-of-health-and-human-services?ref=fdaweb.com)on the nomination of **Robert Califf** to be the next FDA commissioner. The times have changed in the past five years since Califf served as FDA commissioner at the end of the Obama Administration, and prresumably the hearing will look to gain insight into how Califf will run the agency as it navigates the Covid-19 health emergency.

Committee members are also likely to grill Califf on his previous financial ties to industry, particularly after his financial disclosure forms revealed that he made millions of dollars last year from industry ([see earlier story](https://www.fdaweb.com/califf-financial-disclosures-show-millions-from-industry/)). The bulk of Califf’s earnings, $2.7 million, came from Alphabet-owned Verily Life Sciences, according to the documents. He also earned almost $78,000 serving on the boards of two other pharmaceutical companies in the last year, which does not include stock grants and options that could end up adding to the total. Califf also advised five other drug or health tech companies, in roles that were unpaid, according to the disclosures.

Looking back at Califf's first confirmation ([***FDA Webview*** 1/8/2016](http://www.fdaweb.com/login.php?sa=v&aid=D5134381&searchWords=califf&cate=S&stid=%241%24ew5.P20.%24VQt.sdl4LJsjxkyncei8S.)) sheds some light on continuing priorities he may have now for FDA. Then, he identified these priorities — improving clinical trial designs, revising advertising and promotion policies and the agency’s approach to foreign inspections.

Historically, Califf has been very interested in revamping the clinical trial process. Improving the understanding of new drug and device effects in patient subpopulations was a high priority for the agency, [Califf told](http://www.fdaweb.com/login.php?sa=v&aid=D5134381&searchWords=califf&cate=S&stid=%241%24ew5.P20.%24VQt.sdl4LJsjxkyncei8S.) then-Senate HELP Committee ranking member **Patty Murray** (D-WA). Califf also said that using biomarkers and other patient characteristics can enable small, focused trials to evaluate particular populations, adding that when viewed in the “overall context of product development this approach will be a critical tool, and the Precision Medicine Initiative will accelerate the potential.”  

On relaxing advertising and promotion restrictions, Califf has said the goal is to harmonize “the important public health and safety interests served by FDA’s premarket review of new uses of medical products, with the value that sharing relevant scientific information regarding unapproved uses can have in certain contexts, and with First and Fifth Amendment considerations.”

And on improving foreign inspections, particularly FDA’s continued focus on facilities in India and China that seem to have some high-profile GMP deficiencies, Califf has said the agency will exercise its authority to request manufacturing documents in advance of a foreign inspection to better detect problems. This process has been relied on by agency inspectors during the pandemic and several current agency officials are embracing the concept to continue after the health emergency.