Can Califf Bring Clarity and Enhanced Credibility to FDA?

In the face of a host of contentious and controversial policy decisions, President Biden appears poised to bring in an experienced and well-regarded hand to lead FDA. The agency has lacked a permanent leader for more than eight months, as the White House has been unable to identify a new commissioner acceptable to politicians and interest groups on all sides.

So as the clock has ticked down on the Nov. 15 deadline for Janet Woodcock to vacate her acting commissioner role, potentially forcing Biden to appoint another acting commissioner, word is out that the White House will name cardiologist and research pro Robert Califf to the top job, a position he held for almost a year at the end of the Obama administration.

Califf’s appointment will bring much-needed stability to FDA as it contends with a host of difficult policy decisions involving vaccines, new anti-COVID therapeutics, access to e-cigarettes, accelerated approval programs, and budget priorities. Califf may face opposition in the Senate, as partisan politics has come to the fore on all sides. Although he wins plaudits for his experience in medical research and his familiarity with FDA operations and requirements, some consumer advocates and liberals criticize his close ties to industry and pro-development attitude. He will need support from Republicans, which may be more tenuous in today’s hotly divisive climate on Capitol Hill.

Another factor driving the FDA nomination is the recent announcement of retirement plans by Francis Collins, long-time director of the National Institutes of Health (NIH). Biden will want to name a new leader for NIH before the end of the year, and that provides an opening to bring a woman scientist into the administration’s health and science leadership cadre.

Hopefully, the politicians will recognize the importance of experienced leadership for the nation’s leading health agencies and put aside partisan politics to agree on a new FDA commissioner, and then a new leader at NIH. FDA has been well-served by acting commissioner Woodcock, but her tenuous position has exposed her to criticism and second-guessing on all sides. With a global pandemic still raging, a seasoned hand is needed to stabilize FDA’s exhausted workforce, ensure funding continuity, and steer debate and decisions on many difficult scientific and policy issues.