UNPA Senior Political Advisors Patricia Knight and Peter Reinecke forward the following report from Washington, this time with an update and analysis of the recent announcement by the Trump administration regarding the vacant FDA commissioner’s position and its potential impact on the legal status of cannabinoids in dietary supplements.
Please note that this report is not for distribution or re-publication outside of UNPA or for use by media without prior request. Thank you for your understanding and consideration.
FDA COMMISSIONER COMINGS AND GOINGS
On Friday, the president announced his intent to nominate cancer doctor Stephen Hahn to be commissioner of the Food and Drug Administration. The “intent to nominate” is a common procedure used by presidents to gather public reaction to a nomination prior to its being made official. We expect that Hahn will be nominated, assuming there are no hidden problems—an “intent to nominate,” while somewhat of a trial balloon, almost always precedes the actual nomination.
In the interim, the White House also announced that Assistant Secretary for Health Brett Giroir, M.D., became acting FDA commissioner. Under the Vacancies Act, the preceding acting commissioner, National Center Institute Director Ned Sharpless, had reached the maximum time for serving in an “acting” role and has now returned to NCI.
WHAT WE KNOW ABOUT GIROIR
Giroir leads the Public Health Service (PHS), but he does not have an official supervisory role over PHS agencies, including the Centers for Disease Control, the National Institutes of Health and FDA. This is a recent change from past practice. Prior to the Clinton administration, all of the public health agency heads (including FDA) reported to the assistant secretary for health.
That said, Giroir has been designated by the Secretary as lead on certain issues, such as opioids, where he has had occasion to become involved in FDA’s policies. From his work as assistant secretary, we know him to be a quick study, an enthusiastic problem solver and a strict adherent to evidence-based science. Whether he will be in a position to bring those qualities to the CBD issue cannot be gauged at this point.
We hasten to add that key Senate Democrats, such as Sen. Patty Murray, D-Wash., who would be likely to become chair of the Health, Education, Labor and Pensions (HELP) Committee should the Senate majority turn after the 2020 election, have raised concerns about Giroir’s actions on such issues as fetal tissue, where they believe he has displayed an overly conservative attitude. An examination of these concerns could slow the nomination.
The late breaking news is that today the HELP Committee announced a Nov. 20 confirmation hearing on Hahn. We assume that unless there are major new issues that come out, he is likely to be confirmed by the Senate.
WHERE DOES CBD FIT IN?
Without question, CBD will be an issue for the Hahn confirmation, and we will be working with congressional offices to make certain Hahn hears from Congress about the need to establish a pathway for legal CBD sales.
Along these lines, we were intrigued by remarks former Commissioner Scott Gottlieb made at the American Enterprise Institute on Friday. When asked whether the CBD issue would affect the Hahn nomination, Gottlieb is reported to have replied: "I think the FDA's hand is going to get forced on this (CBD). I saw it when I was there—this was a top question that came up in meetings with Congress. It's going to be hard to confirm an FDA commissioner without some kind of pathway on this.”
Gottlieb is assuming that one or more senators could hold up a vote on Hahn’s nomination unless there is some commitment by FDA to create a legal CBD pathway. His remarks may be a message to his colleagues about the importance of working to resolve this issue.
It is also important to know that even a commitment by a new FDA commissioner might not assure that FDA would be able to take the timely and effective action we seek and that a legislative change may still be necessary.
UNPA will be working with the other trade associations to make certain Hahn is appropriately briefed on the need for a dietary supplement pathway for CBD during this confirmation process. However, it is also important to know that even a commitment by a new FDA commissioner might not assure that FDA would be able to take timely and effective action we seek and that a legislative change may still be necessary.
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