KELLY: Does HHS's vaccine webpage reflects the department's view on covid vaccines?
RFK JR: I haven't seen the website
KELLY: It's kind of troubling that you're unaware of what your own department's website states. It says they're safe and effective.
I wrote about this a while back. Can’t believe it’s actually been almost two years.
news.bloomberglaw.com/pharma-and-l...
At the same time, orphan drugs are some of the costliest ones on the market right now
In the Medicare guidance document, CMS made clear they would lift the price, negotiation, exemption, even if the drug has not been approved for the additional indications. Obviously some groups were not happy about that and were looking to change it
a key point here is that FDA grants the orphan drug designation **before** approval. So you don’t know that the drug will actually work on multiple diseases or populations just because there’s a design designation for that indication
But back to the orphan drug provision in the E&C reconciliation text. Some background:
The Inflation Reduction Act exempts drugs with an FDA orphan drug designation from Medicare drug price negotiations.
But if there is more than one Orphan Drug designation, that exemption no longer applies.
Read more about last night’s bill text from @bgov.com’s @erincdurkin.bsky.social
news.bloomberglaw.com/pharma-and-l...
RARE DISEASES folks: medicaid work requirements were obviously the big news from last night release of the E&C reconciliation bill.
But there’s also a pretty big win for rare disease drug makers and groups like @nordrare.bsky.social
DOGE head Amy Gleason denied responsibility for mass federal worker firings in a private group chat message obtained by the Chronicle. www.sfchronicle.com/politics/art...
Noticeably silent amid the upheaval at HHS? Big pharma. Every new drug has NIH somewhere in its DNA--and NIH funding supports the training of their workforce. Now they're finding out FDA isn't safe, either. Wrote about how keeping quiet isn't working My latest @opinion.bloomberg.com (gift link):
Had a peaceful, gorgeous morning viewing the cherry blossoms over sunrise
…then I checked my work inbox …
The mixed response from congressional Republicans to the Trump administration’s cuts for NIH F&A costs could signal reductions for the National Institutes of Health down the line when lawmakers draft spending bills, Nancy Vu reports for @bgov.com
news.bgov.com/bloomberg-go...
Scoop: Trump DOJ removes head of Tax Division, a 40-year veteran who is latest civil servant reassigned to the sanctuary cities office. He's resigned, prompting alarm over how Trump may deploy tax enforcement against enemies. w/ Erin Slowey, David Voreacos news.bloomberglaw.com/us-law-week/...
📣 Since the response to my archive index of the CDC & FDA websites has been so positive, I'm tackling a much larger site: The Centers for Medicare & Medicaid Services (CMS).
The CMS site is 10x larger than either the CDC or FDA sites, so this may take awhile...
acasignups.net/25/02/07/lin...
Scoop: DOJ tells all US attorneys to justify retaining any probationary employee who isn't working on immigration, national security or public safety cases. They have until Monday to explain why these recent hires should be allowed to keep their jobs. news.bloomberglaw.com/us-law-week/...
“That includes things like keeping the lights on, maintaining the facilities, and running institutional review boards to look at human subject [study] applications,” Collins said at a May 17, 2017 hearing.
news.bloomberglaw.com/pharma-and-l...
Francis Collins told the house spending panel at the time that forcing universities to shoulder a greater share of the “indirect” costs of grant-funded studies may make their biomedical research efforts unsustainable.
Reps. Tom Cole (R-Okla.) and Rosa DeLauro (R-Conn.), then the top GOP & Dem on Labor-H stopped the cuts. They now lead the full committee
But Rep. Andy Harris (R-Md.) was a big proponent of cutting F&A, saying that money could fund more research.
Trump 1.0 proposed similar cuts in a budget blueprint they released almost eight years ago (March 16, 2017) as part of a larger effort to slash NIH's budget by $6 billion ($32B down to $25.9B).
news.bloomberglaw.com/pharma-and-l...
On the issue of NIH cutting indirect costs down to 15% (which has averaged 27% to 28% over time, according to their grants statement).
What does this portend for the Trump 2.0's first budget proposal?
some context 👇
More from @bgov.com’s Nancy Vu on RFK jr’s nomination moving to the Senate floor
No floor vote scheduled, but Thune has generally been moving to confirm Trump’s cabinet picks swiftly (he laid out a pathway for it last month)
news.bgov.com/bloomberg-go...
Several senators made statements after the vote. Cassidy was not one of them. However, he does have a statement on X.
So what commitments did Cassidy get from the White House and why does he have any confidence they will follow through on them?
Wish I had written that with fewer typos🤦🏻♀️🤦🏻♀️🤣🤣 but yes exactly
Yes. I 've mentioned it before and it is so important. The government is filling in a key market failure and we still have huge gaps and needs to new antibiotics to address resistance etc.
Now here’s how much NIH has been spending on obesity research, according to its website on categorical spending. Could it be more? Sure but that’s really up to Congress, which Sen. Collins pointed out yesterday
The point is, it’s not the big money maker for drug companied that RFK jr implied it was, and if it weren’t for NIH, a lot of these infectious disease has probably wouldn’t be studied at all.
The NIAID had trouble finding industry partners for Ebola and West Nile vaccine candidates developed by NIH scientists.
J&J shut down their R&D in infectious diseases
www.fiercebiotech.com/biotech/john...
It is true that NIAID is the second largest of the NIH’s 27 institutes and centers (NCI is the largest)
But Covid being a once-in-a-lifetime exception, infectious disease is *not* typically a big money maker for drug companies. In fact, things were really trending the other way.
“The problem is there's been an imbalance. We've devoted all of these dollars to infectious disease and to drug development to make NIH an incubator for the pharmaceutical industry and very little to chronic disease,” RFK jr told Collins
Okay so… (sorry I keep running out of room)
