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

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.

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