Likely new FDA Commissioner's experience seen as plus by industry

By Hank Schultz contact

- Last updated on GMT

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

Related tags: FDA Commissioner, Fda, Regulation, Ndi draft guidance, Food

Industry stakeholders have welcomed the news that the Biden Adminstration is reportedly ready to name Dr. Robert Califf, MD as the new FDA Commissioner, given that he has prior experience at the Agency during the Obama years.

Over the past several days it has been reported that the White House staff has been vetting Califf as a candidate to fill the position currently being held by Acting Commissioner Dr Janet Woodcock, MD.  

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.

Industry stakeholders greeted the news with cautious enthusiasm.  Dr Califf’s experience is a plus;  whether he can light a fire under certain policy initiatives that have lost steam in recent years is another question.

CRN: Dr. Califf’s experience will help move agenda forward

“CRN congratulates Dr. Robert M. Califf for being nominated to lead FDA as its next commissioner. We look forward to working with Dr. Califf to strengthen the dietary supplement industry and protect consumers by ensuring products are safe and meet regulatory requirements,”​ said Steve Mister, president and CEO of the Council for Responsible Nutrition.

Mister said from CRN’s point of view the following should be Dr Califf’s main priorities:

  • Increase funding to the Office of Dietary Supplement Programs (ODSP) at FDA, recognizing this Office must keep pace with the rapidly growing industry it oversees.
  • Work with Congress to enact legislation to establish mandatory product listing for supplements.
  • Establish a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement.
  • Issue final guidance on the labeling of probiotics.
  • Issue final guidance for new dietary ingredients, along with an official list of pre-DSHEA dietary ingredients that are “grandfathered” under the 1994 law.
  • Protect consumers and strengthen incentives for innovation with more proactive enforcement of the existing law for dietary supplements.

“CRN has enjoyed a strong working relationship with FDA and looks forward to continuing this relationship under Dr. Califf’s leadership,”​ Mister added.

NPA: Can Dr Califf work with the tools at hand?

Califf
Dr Robert Califf MD

Daniel Fabricant, PhD, chairman and CEO of the Natural Products Association is himself a former FDA executive, as former head of the then Division of Dietary Supplement Programs. He said a look back at what Dr Califf had to say during his first confirmation hearing before the Senate shows how many policy initiatives have hung fire at the Agency in the intervening years.

In late 2015 Dr. Califf had this to say in response to a question from former GOP Senator from Utah, Orrin Hatch: “FDA’s dietary supplement program office is currently undergoing a strategic review of its structure and practices, including a review of the underlying statutory and regulatory authority for dietary supplements and how the Agency has traditionally used this authority.  This effort is intended to ensure that we are using our full authorities in the most effective way possible​.“

Fabricant said little progress has been made in the intervening six years. He said from NPA’s point of view FDA’s budget has increased during that period but there is little to show for it.

“I don’t imagine that the strategy that emerged from that review was for no progress on NDIs, no progress on enforcing on knock off imports, and no progress on CBD but that’s what the American public has received. More interesting is that the agency has received more money through appropriations over the past few years and done less with it (i.e., inspections are down, in addition to the items above) and is now asking for more authority which defies logic,” ​he said.

Fabricant said he hopes Dr. Califf will “look for ways to use existing authorities, which are more than adequate as he clearly stated in his hearing before the HELP committee in 2015.”

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