On September 15, 2015, President Obama announced Robert M. Califf, MD, MACC, as his nominee for Commissioner of the US Food & Drug Administration (FDA).
Dr. Califf is a world renowned cardiologist and clinical trial expert, and has served as FDA’s Deputy Commissioner for the Office of Medical Products and Tobacco since February 2015. As Deputy Commissioner, he:
- Provides executive leadership to CDER, CBER, CDRH, and the Center for Tobacco Products;
- Oversees the Office of Special Medical Programs; and
- Provides direction for cross-cutting clinical, scientific, and regulatory initiatives.
Background
Dr. Califf attended Duke University School of Medicine and has maintained deep ties with the University since graduating. Prior to joining FDA, he worked as a professor of medicine and vice chancellor for clinical and translational research at Duke. Furthermore, Dr. Califf served as the director of the Duke Translational Medicine Institute and the founding director of the Duke Clinical Research Institute. During his career, he has also worked as a consultant, providing regulatory assistance and oversight to a number of drug companies.
He has served on the Institute of Medicine (IOM) committees for an assortment of studies, and on the Board of Scientific Counselors for NIH and the National Library of Medicine, and on advisory committees for:
Opponents of Califf’s Nomination
Last month, the AIDS Healthcare Foundation (AHF) asked President Obama to rescind Dr. Califf’s nomination, accusing the nominee of “pimping for the pharmaceutical industry’s efforts to avoid regulation.” Among other claims, AHF also expressed concern over Califf’s involvement as a regulatory consultant for a company called Faculty Connection.
Recent Confirmation Hearing
Despite the existence of several oppositional groups, President Obama did not pull the nomination, and on Tuesday, November 17, 2015, Dr. Califf was questioned and testified during a confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions (HELP). During this hearing many Senators expressed their support for Dr. Califf. Califf also received questions which sparked more intense discussion on topics such as increasing drug prices, his previous involvement in the industry, and approval times for new drugs.
In response to concerns over increasing drug prices, Califf explained that, although FDA does not have the authority to control drug prices, the Agency could address the issue using various strategies such as organizing and expediting the clinical trial process.
Despite the recent criticism, many senators seemed to feel as though his experience is what makes him the right candidate for this position. Additionally, Chairman of the Senate HELP committee, Sen. Lamar Alexander (R-TN), commented on his ties to the industry, stating that Dr. Califf has been “through an exhaustive vetting process and that neither Alexander nor his staff have encountered any issues that might” disqualify his candidacy.
Prior to the hearing, Democratic presidential candidate Senator Bernie Sanders (D – VT) said that he will be voting against Dr. Califf; and on Tuesday he confirmed that statement, saying “we need a commissioner who’s going to stand up to the industry – you are not that person.”
When asked about the stockpile of applications for generic drugs, Califf provided a few reasons for the backlog and concluded that, although the Agency has gone much further than the goals of the Generic Drug User Fee Act (GDUFA) intended, he still feels they can do better.
Senator Elizabeth Warren (D – MA) inquired about the possibility of Califf lowering the standards for approval of new drugs to which he replied, “I’ve never been a proponent of lowering standards for anything.”
The Senate HELP committee has not provided a date by which we can expect its decision on Dr. Califf’s nomination. However, given the amount of support that was shown during this hearing, it would appear that his confirmation will occur.
For more information or details of the meeting, view the full video of the committee hearing here.
