News Feature | January 13, 2017

Califf Stepping Down As FDA Commissioner As Trump Considers Replacement

By Jof Enriquez,
Follow me on Twitter @jofenriq

Dr. Robert Califf

U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf is formally stepping down before the Trump administration starts on January 20. Replacing him on an interim basis is Dr. Stephen Ostroff, who served in the same capacity before Califf assumed his position at the helm of the agency just over a year ago. A former FDA deputy commissioner and high-profile Silicon Valley investors are among those in the running to lead FDA.

According to Politico, FDA spokeswoman Jennifer Rodriquez has confirmed that Califf has "formalized" his departure from FDA. Former FDA deputy commissioner and venture capitalist Scott Gottlieb is said to be the leading candidate to replace Califf. President-elect Trump also is reportedly considering Jim O'Neill, a Silicon Valley investor, who also served as principal associate deputy secretary of health and human services under the George W. Bush administration.

Trump on Thursday met with O'Neill and another Silicon Valley insider, Balaji Srinivasan, reports CNBC. Both "are being considered for positions in the FDA," incoming White House press secretary Sean Spicer said on a daily briefing call.

However, pending official nomination of a new FDA commissioner, the federal watchdog agency will be headed by Ostroff, who currently is FDA's deputy commissioner for foods and veterinary medicine, according to STAT. Ostroff served as acting FDA commissioner during the transition from former FDA chief Margaret Hamburg until Califf's appointment.

President Barack Obama nominated Califf in November 2015 to replace Hamburg, who headed the agency for nearly six years. Her replacement's tenure appears to be a much shorter one, having been officially confirmed last February.

With Donald Trump set to enter the White House, observers had believed Califf to be on the way out. Califf told the Washington Post in late December that he had not had any contact with the Trump transition team to stay on, but said, “Everyone who knows me knows I have just had fun every day on the job.”

Califf has only started to make his mark as FDA commissioner, placing a focus on strengthening the agency's workforce and evidence generation, including gathering real-world evidence to support regulatory decisions and accelerating the delivery of new drugs and devices for patients.

He drew parallels between his administrative job at FDA and his background as a clinical cardiologist, as well as a Duke University researcher, in making important decisions, based on solid evidence, that profoundly impact people's lives.

"It’s very noticeable when we make decisions with good evidence," Califf told the Washington Post. "It's still emotionally charged because we regulate such a large part of the economy, and there are winners and losers. But when we have good evidence, it’s easy to defend the decisions and the arguments are typically good arguments to have about how you interpret good evidence."

Regardless of whether Califf stays or goes, "some type of FDA reform will likely surface once the Trump administration comes in, along with a certain level of continuity of initiatives begun under Obama, such as the Cancer Moonshot, and key Califf initiatives such as EvGen/RWE," writes D.C.-based attorney Nancy Bradish Myers, president of Catalyst Healthcare, in a recent MDO guest column.