UNPA POLITICAL UPDATE | RE: Califf Nomination to be FDA Commissioner

UNPA POLITICAL UPDATE

FROM:  Trisha Knight and Peter Reinecke, Senior Political Advisors
RE: Califf Nomination to be FDA Commissioner

*********************

This morning, the Senate Health, Education, Labor and Pensions Committee (“HELP”) held a two-and-and-one-half hour hearing at which Dr. Robert Califf was the sole witness testifying in support of his nomination to be the next Commissioner of Food and Drugs.

There were a wide range of questions asked, but many of the Senators’ interests centered on clinical trials, the agency’s response (or perceived lack thereof) to the opioid overuse crisis, and abortion. There were no questions asked about dietary supplements or CBD, however, Committee Chair Patty Murray (D-WA) said the following as part of her opening statement:

“We also need to make sure FDA has authority it needs to keep families safe from products that have gone on too long with too little scrutiny:  When it comes to cosmetics…..

When it comes to dietary supplements, people across the country who are looking to make healthy choices are faced with a shelf full of products that make claims about their health benefits, but lack rigorous oversight because FDA does not have authority to collect basic information about those products or even know what products are on the market.  Families buy and use these products every day.  They deserve to know all the products they entrust their health to are subject to the same type of FDA oversight they already trust to keep their food, drugs and devices safe.”

We assume she is referring to discussions about legislation to require listing with FDA dietary supplements and their ingredients (aka mandatory product listing – MPL).   Senator Murray’s Committee staff has been in discussions with us and others about possibly including a proposal like an amendment to the FDA user fee legislation expected early in 2022.   There could be broader concerns that underlie the statement.  We are following up with her staff about this.  We do know that the staff of Senator Richard Burr (R-NC), who is the top Committee Republican,  has met with Murray staff on MPL, and Burr staff have contacted UNPA and the other trades about beginning meetings to receive our perspective on the issue.

It appears the odds of him being confirmed by the Senate to lead FDA are good.  He was handily confirmed before when he served the last 10 months of the Obama Administration.  While the situation has changed somewhat with several senators expressing grave concerns about how the agency handled the opioid epidemic during his prior tenure, Senator Burr did support Califf at the hearing, and said he hoped other Committee Republicans would as well.  From this it is likely to assume he will be confirmed with a bipartisan mix of supporters and detractors.  While there is some chance the vote on his nomination could occur before the end of the year, it will likely get pushed until January 2022.