[Editor's note: This article has been updated to include the White House's announcement.]

President Joe Biden nominated Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration on Friday.

If confirmed, Califf, a cardiologist who also led the FDA during the last year of President Barack Obama's administration, will step into a position that has been vacant for months.   

"Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic," said Biden in a statement.

"As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA," he continued.

WHY IT MATTERS

The FDA has lacked a Senate-confirmed leader since Biden took office in January of this year. The current acting commissioner, Janet Woodcock, can only legally serve until November 15 if Biden does not nominate anyone. 

With that deadline looming, numerous outlets were pointing to Califf as the expected choice prior to the announcement on Friday morning.  

Califf, who has been a paid consultant for multiple large pharmaceutical companies, is currently senior advisor at Verily Life Sciences and Google Health. He and Biden also collaborated on the president's Cancer Moonshot Initiative. 

Califf would have a busy to-do list as FDA responds to the COVID-19 crisis, with new decisions to make about vaccines and antivirals. The agency is considering expanding eligibility for Pfizer and Moderna booster shots for all adults, for example.

Observers told Politico that they expected Califf to be confirmed again by the Senate, which approved his last nomination 89 to four.  

THE LARGER TREND  

The FDA has in recent months also fine-tuned its policies around software in medical devices.  

This past week, the agency published a long-awaited draft for its Content of Premarket Submissions for Device Software Functions, aimed at replacing an outdated guidance first issued in 2005.

The new draft, said Bakul Patel, director of the FDA's Digital Health Center of Excellence in the Center for Devices and Radiological Health, "describes the information that the FDA considers important during its evaluation of the safety and effectiveness for device software with one or more device functions, including both software in a medical device and software as a medical device."  

The document followed the agency's release of "guiding principles" for artificial intelligence and machine learning device development in October.  

ON THE RECORD  

"Rob Califf is a good choice," said Dr. Aaron S. Kesselheim, a professor of medicine at Harvard Medical School, to the Washington Post's Laurie McGinley. "Califf certainly spent the vast majority of his early career working on clinical trials … and understands the value of rigorous data."

"I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making," said Biden in his Friday statement. "Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment."

Kat Jercich is senior editor of Healthcare IT News.
Twitter: @kjercich
Email: kjercich@himss.org
Healthcare IT News is a HIMSS Media publication.