Califf Financial Disclosures Show Millions from Industry
New financial disclosure documents showing Robert Califf earning millions of dollars last year from industry could throw a wrench in the confirmation process for the Biden Administration’s pick to lead FDA. “Califf has cashed in on the revolving door both going into government and back out again into the private sector,” Public Citizen government ethics expert Craig Holman told Politico, adding that his “relationships are so extensive that he is not an appropriate nominee.”
The bulk of Califf’s earnings, $2.7 million, came from Alphabet-owned Verily Life Sciences, according to new financial documents obtained by Politico. Califf, who served as commissioner during the last year of the Obama Administration, joined Verily in a part time capacity shortly after president Trump took office. In 2019, Califf accepted a full-time role as the head of medical strategy and policy for Google Health and Verily. Politico also says he 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.
A White House official defended Califf’s industry work, arguing that “almost anyone who is qualified to run the FDA will have experiences with drug makers.” Califf’s confirmation in 2016 was meet with similar criticism about his industry ties, but he sailed through on a 89 to 4 Senate vote.
Meanwhile, looking back at Califf's first confirmation (FDA Webview 1/8/2016) sheds some light on continuing priorities he may have in store for FDA. At that moment in time, he identified these priorities — 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, Califf told Senate HELP Committee ranking member Patty Murray (D-WA) at the time.
Califf said he supported “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.”
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 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.”
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 had 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.