Trade organizations welcome Califf’s formal nomination to lead FDA

By Hank Schultz contact

- Last updated on GMT

©Getty Images - Ildo Frazao
©Getty Images - Ildo Frazao

Related tags: regulations, Fda, FDA Commissioner

As expected, the Biden Administration has nominated Dr Robert Califf, MD, as the new FDA Commissioner. Dr Califf previously served in the role during the Obama Administration.

Dr Califf’s name was first floated as a possible candidate to replace action Commissioner Dr Janet MD, in mid October​.

Prior experience

Dr Califf led the Agency from February 2016 to the end of the Obama Administration after a year as the agency’s deputy commissioner for medical products and tobacco, according to FDA’s website.  He was succeeded as commissioner by Dr Scott Gottlieb, MD.

Dr Califf received his MD at Duke University Medical School and served as a professor of cardiology at the school.  He founded and directed the Duke Clinical Research Institute at the school, which at the time he was first nominated to lead FDA had a budget of more than $320 million.

Trade organizations active in the dietary supplement reacted positively to the news with a few caveats.

“Dr. Califf is an excellent choice to lead the Agency at such an important time for public health. In addition, his experience and insights on digital health and technology will be critical for helping to shape the future of FDA and the growth of consumer self-care,” ​said Scott Melville, president and CEO of the Consumer Healthcare Products Association.

“Once confirmed, we look forward to continuing to work with the new commissioner on shared priorities to strengthen the safety and accessibility of self-care options,”​ Melville added.

"We support his confirmation and will look forward to working with Dr. Califf and FDA leadership to strengthen the dietary supplement industry,"​ said Steve Mister, president and CEO of the Council for Responsible Nutrition.

Daniel Fabricant, PhD, president and CEO of teh Natural Products Association, said the nomination comes as a critical juncture.

“NPA welcomes the return of a Senate confirmed commissioner to lead the Food and Drug Administration.  If confirmed, Dr. Califf will be responsible for leading the Agency during one of the most challenging moments in history.  We look forward to hearing Dr. Califf’s views on enforcing DSHEA, regulating the rapidly expanding CBD industry, and addressing the issue of adulterated ingredients through the NDI process,” ​he said.

Questions about opioid epidemic

Loren Israelsen, president of the United Natural Products Alliance (UNPA) noted that while Dr Califf does have prior FDA experience, he does not have much of a track record on dietary supplement industry issues.  Also, during his last nomination process questions were raised about his prior work for pharmaceutical companies. Influential Senators Joe Manchin (D-WV) and Bernie Sanders (D-VT) opposed his nomination in 2016 on these grounds.  Manchin represents a state hard hit by the opioid abuse epidemic.

Sen. Manchin’s office issued a statement today saying the nomination “makes no sense as the opioid epidemic continues to wreak havoc on families across the country with no end in sight.”  

Given the razor thin margin for Democrats in the Senate, it’s unclear what effect this dissension might have, Israelsen noted.

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