In what has been a glacially paced nomination process, the Biden Administration announced on November 12 that it would, in fact, be nominating Dr. Robert Califf to return to his role as FDA Commissioner. Acting Comissioner Janet Woodcock indicated in a tweet that she would be remaining in the role of Acting Commissioner during the confirmation process.
Since he has been confirmed before it would seem likely that he will be confirmed again. Though, of course, it is a very different political climate and a different Senate than it was the first time. Media coverage regarding the nomination has been largely focused on concerns expressed by some about Dr. Califf’s past work with pharmaceutical companies in clinical research. More specifically some are concerned that this association might be problematic vis a vis addressing the opioid epidemic in this country. Ultimately this past was not an issue the first time in 2016 when he was confirmed by a vote of 89 to 4.
One of those four votes against confirmation has already announced opposition this time around. The reasoning is again based on Dr. Califf’s association with the pharmaceutical industry – an objection that seems less sure-footed this time around. In the first place, he has already been FDA Commissioner and there was nothing during his tenure that would suggest his industry associations had a negative influence on FDA policy during that time, whether on the topic of opioid policy or any other issue. Secondly, one actually wants someone who knows research and understands the industry to be the head of FDA. It would therefore seem to be even less of an issue today.
What is perhaps more substantive this time around is that FDA is in such a different spot than it was in 2016 when Dr. Califf was first at the helm of the agency. Focus should be less on the perennial concerns about past associations with industry (which is always a question during FDA Commissioner confirmations) and more on addressing the issues that have torn at FDA’s reputation since Dr. Califf’s first tour of duty with the agency.
For example, any nominee should face questions about the future role of the accelerated approval program. For all of 2021 trade media have carried headlines about the fact that this regulatory pathway is under attack and FDA officials have stepped up to defend the program. Two recent white papers – one by Friends of Cancer Research and one by the Institute for Clinical and Economic Review (ICER) have outlined suggestions for reform to the accelerated approval program designed to make it more transparent and consistent. What will a new commissioner do to shore up this critical pathway?
Another related issue is the loss of credibility from the recent self-inflicted harm by the agency in its approach to approving a new treatment for Alzheimer’s, resulting in an unprecedented level of criticism directed at the agency with a consequence that three members of the FDA advisory committee resigned in protest, creating a crisis for the entire advisory committee process. (It is perhaps noteworthy that some committees at present are experiencing large numbers of vacancies – Gastrointestinal 6 vacancies; Oncology 2 vacancies; Peripheral and CNS 4 vacancies; Pharmaceutical Science 5 vacancies.) How will a new commissioner restore confidence in the advisory committee system for both the public and research community?
And this week a bill was introduced in the U.S. House of Representatives by Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) that, if passed, would be the follow-up to the 21st Century Cures Act that was signed into law in 2016 designed to speed up regulatory consideration of new treatments. Among other changes the proposed law would bring, the new and improved version offers the possibility of altering the accelerated approval pathway even further by allowing use of a wider range of evidence for efficacy, including real world evidence. Dr. Califf is an expert in clinical study. His opinion on this is much more substantive than his past associations with industry. How does a new commissioner assess the role of real world evidence in the approval of new medicines?
These are the kinds of substantive issues at question that should serve as a basis for examination of any new incoming FDA Commissioner.
This job is not an easy one. If confirmed, Dr. Califf deserves our best wishes. There are patient communities in true need, there is a large industry with good and bad players, there are multiple competing interests – there are those who believe in the agency and those who never will. There is an endless supply of critics and skeptics. It takes courage, fortitude that support the pursuit of clear goals that are clearly communicated to a myriad of stakeholders. Good luck to any nominee who is confirmed and to any person who must assume the role of Acting Commissioner while the process plays out.
