There were many reasons for the U.S. Senate not to confirm RFK Jr. as HHS Secretary. Reasons that transcended politics.
Nonetheless, Senate Republicans confirmed him today for that post. Some of them had voiced serious concerns before including one physician Senator, Dr. Bill Cassidy, but they all voted for Kennedy anyway.
All except Mitch McConnell, which is an odd twist.
So what happens now?
America’s health system ahead under RFK Jr.’s leadership
In my view, Kennedy will mostly negatively impact Americans’ health. How so?
It’s a safe prediction to say that vaccine use in our country will suffer, making us less safe.
There will be more preventable disease. The present state of bird flu in the U.S. is particularly worrisome at the moment. Not a great time to be chugging raw milk.
The list goes on.
Kennedy is also now in a position to hurt NIH research, something we’ve already seen happening more generally in the last 3 weeks.
Note that conservative Scott Gottlieb, Trump’s first-term FDA Commissioner, was opposed to RFK as HHS Secretary.
Kennedy’s impact on the cell and gene therapy space
What about the cellular and gene therapy fields under RFK?
It’s probably not going to be a great time overall, although some stocks or particular areas of research might benefit.
RFK Jr. has already suggested that the FDA was suppressing stem cells. My sense is this was entirely inaccurate.
While it’s not clear for sure what he means, it seems likely he’s referring to unproven stem cells sold by clinics all across the country. He seems particularly interested in umbilical cord cells.
So, he’s likely to be an ally of unproven cell and regenerative clinics (and their supplier firms) as HHS Secretary. In my view, that’s a recipe for more people losing their hard earned money and also being put at various health risks.
A stop to warning letters to unproven clinics and suppliers?
For example, Kennedy can make the FDA stop important enforcement actions such as sending warning letters to even the worst of the clinics and their supplier firms. He can do even worse stuff on that front, but I’m not going to mention it as I don’t want to give anyone ideas.
Kennedy’s specific impact on the FDA’s CBER branch, which recently has been on a historic streak of issuing more biologics warning letters, may lead to abrupt change.
I expect we will see a point after which there are almost no warning letters issued by CBER anymore on unproven cell therapies. Maybe just a few a year on particularly egregious cases. I hope I’m wrong on this, but it was one of my 25 predictions for our field for 2025. As also noted in those predictions, I think we’ll see some departures of key FDA leadership. It’s already started overall, but CBER may also lose leaders.
One hope here on the FDA front is that likely FDA Commissioner Marty Makary may push to continue the agency’s enforcement actions on unproven clinics and suppliers. I don’t know what the odds are for that though. He seems like a serious physician-scientist so maybe there’s hope.
Could Kennedy lead to some good citizen cell and gene therapy biotechs get quicker, well-deserved approvals? Maybe.
One of his broader ideas, to stop drug commercials on TV, seems like a good one.
Intersting. But you’re not a Doctor.
I’m not a physician but how is that relevant to this discussion? I am a scientist and professor.
“Note that conservative Scott Gottlieb, Trump’s first-term FDA Commissioner, was opposed to RFK as HHS Secretary.” OR “Note that PFIZER BOARD MEMBER Scott Gottlieb was opposed to RFK as HHS Secretary.
@Bill, just because he’s on a pharma board doesn’t mean he’s wrong about Kennedy. I believe he’s right.
HIs interests are Pfizer’s interests. He’s not simply some “Trump conservative” who opposes RFK. The big pharma-FDA revolving door is a big problem.
I doubt his position with Pfizer has anything to do with his being outspoken against Kennedy. Even Kennedy’s own family doesn’t think he’s qualified to be HHS Secretary. Kennedy is also not a “real” conservative and does not seem to have a good grasp on many key things including vaccine data. So there are plenty of reasons for Gottlieb to speak out against him. On just the stem cell front, Gottlieb was all for rigorous standards, while Kennedy seems to be a friend of unproven clinics as best as we can tell so far.
On the other hand, in general I do agree that there should be some limitation on the FDA leadership-big pharma thing. Maybe a one-year period after being a leader at the FDA when you cannot be on a pharma board?
Thanks for this article.
It really remains to be seen how he will enact things. Too early to know and say.
While limiting those stem cell interventions that are questionable, it would indeed be amazing if he would more directly support, for example, infusions with mesenchymal umbilical-chord derived stem cells, if done in a responsible fashion.
The FDA has slow-walked that very promising medical development, probably for lack of sufficient scrutiny.
If this changes, that’s a good thing.
Thank you.