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# Califf Romps into Top FDA Slot
- URL: https://www.fdaweb.com/califf-romps-into-top-fda-slot/
- Published: 2016-02-24T12:00:00.000Z
- Updated: 2026-09-15T02:38:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134874

> The Senate 2/24 voted 89 to 4 to approve the appointment of **Robert Califf** as the next FDA commissioner. Opposing votes came from Sens. **Joe Manchin** (D-WV), **Edward J. Markey** (D-MA), **Richard Blumenthal** (D-CT) and **Kelly Ayotte** (R-NY), all complaining that Califf was not the ideal candidate FDA needed to tackle the “deadly epidemic” occurring with prescription opioid products. Before the vote, Ayotte joined Manchin and Markey in calling on the Senate to pass the [Comprehensive Addiction and Recovery Act](http://www.ayotte.senate.gov/?p=press%5Frelease&id=1777&ref=fdaweb.com) — bipartisan legislation she is leading to combat the ongoing national crisis of addiction to opioid drugs.  
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> Now Califf can focus on the priorities he identified during his confirmation hearing — improving clinical trial designs, revising advertising and promotion policies and the agency’s approach to foreign inspections. Improving the understanding of new drug and device effects in patient subpopulations is a high priority for the agency and it will “require a comprehensive, multifaceted approach using a concept known as ‘quality by design,’” [Califf told](https://www.fdaweb.com/califf-makes-improving-trial-designs-a-high-priority/) Senate HELP Committee ranking member **Patty Murray** (D-WA).  
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> Califf said the “general tools consist of small focused trials in people with common characteristics using clinical and molecular markers and, on the other extreme, very large trials using electronic health records and quality registries to provide a low cost data system. Each circumstance is somewhat different and carefully planned trials to most efficiently answer the important questions are needed. All of this needs to occur in the context of more efficient networks of research sites with standard procedures and common data standards and terminology.”  
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> Califf 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 the other hand, the use of integrated health systems, community clinics, and community engaged research in combination with electronic health records and registries built on informed consent and developed to improve quality offer the realistic opportunity to do much larger trials with more generalizability at a dramatically lower cost. Considerable work on this approach is already underway at FDA and it will accelerate in the upcoming year.  
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> 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.”  
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> 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. He said the agency is planning a pilot program to use the authority ahead of a small number of already-planned inspections. FDA believes, according to Califf, that use of this authority “in advance of an inspection could lead to efficiencies by allowing FDA investigators to maximize the use of their time while on site. FDA is seeking to assess the best use of this authority by gathering data through this pilot effort to evaluate, for example, the appropriate scope and volume of records to request, and the burden of producing and reviewing those records.”