Public Health News | Measles outbreak, RFK Etc

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nrsair said:
Received a communication from FDA asking us to limit the number of submissions for a particular product to 2 for the rest of the year. Submissions meaning data from studies that support updates to the prescribing information. This hasn’t ever happened in anyone’s recollection.
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Can you translate this? Sounds as if you’re saying the FDA wants less frequent data from you to support something — some kind of pharmaceutical?

Are those submissions to the FDA currently on a regular cadence? Or sporadic as new data comes in and gets pushed out?
 
nrsair said:
Received a communication from FDA asking us to limit the number of submissions for a particular product to 2 for the rest of the year. Submissions meaning data from studies that support updates to the prescribing information. This hasn’t ever happened in anyone’s recollection.
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In a related story, does anyone have a recollection of the FDA suddenly reducing its force by 50% or more?

These fucking idiots have no idea what they are doing.
 
duluoz said:
Can you translate this? Sounds as if you’re saying the FDA wants less frequent data from you to support something — some kind of pharmaceutical?

Are those submissions to the FDA currently on a regular cadence? Or sporadic as new data comes in and gets pushed out?
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I think he's referring to stage 3 trials that occur after a medication is approved for use. The trials don't just stop: the medication is studied, in the field so to speak, to see if the data from earlier clinical trials is borne out, or if there are new problems that weren't uncovered earlier, or if there are potentially off-label uses to study.

One important function of these trials is to assess safety over a long period of time. When a drug is first evaluated for safety, the study lasts for a year, I think. The other poster has far more insight on that than I do. But whatever the time frame -- a year, two years, 6 months -- none of the initial studies can study 10-year health impacts, or 20 year health impacts.

It's not a regular process, in the sense that there are statutory deadlines or a set cadence, but it's regular in the sense that it happens frequently and the FDA used to welcome all additional data.
 
duluoz said:
Can you translate this? Sounds as if you’re saying the FDA wants less frequent data from you to support something — some kind of pharmaceutical?

Are those submissions to the FDA currently on a regular cadence? Or sporadic as new data comes in and gets pushed out?
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Sorry, wrote that between meetings fully in my regulator affairs mode. When a company gets a medication or vaccine approved, there are usually further studies planned throughout the life cycle. For example, company A has a chemotherapy that gets approved for use in patients with stage 4 disease, then wants to show that it I improves outcomes in patients with stage 3, or company B has a flu vaccine that is effective in adults and wants to use it in pediatric patients. Each expansion of the indication or population will require an additional study evaluating safety and efficacy for that specific case. Once the study is conducted, companies have to organize the data and submit everything to FDA for their evaluation. Companies can submit as many changes as they like- they’re charged a fee with each one, which is part of how FDA is funded.

For the product in question (you’ve almost certainly seen a commercial for it), we had four planned submissions over the second half of the year. FDA has asked us to limit it to two, which apparently is pretty unprecedented.
 
nrsair said:
Sorry, wrote that between meetings fully in my regulator affairs mode. When a company gets a medication or vaccine approved, there are usually further studies planned throughout the life cycle. For example, company A has a chemotherapy that gets approved for use in patients with stage 4 disease, then wants to show that it I improves outcomes in patients with stage 3, or company B has a flu vaccine that is effective in adults and wants to use it in pediatric patients. Each expansion of the indication or population will require an additional study evaluating safety and efficacy for that specific case. Once the study is conducted, companies have to organize the data and submit everything to FDA for their evaluation. Companies can submit as many changes as they like- they’re charged a fee with each one, which is part of how FDA is funded.

For the product in question (you’ve almost certainly seen a commercial for it), we had four planned submissions over the second half of the year. FDA has asked us to limit it to two, which apparently is pretty unprecedented.
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Are these additional trials labeled stage 3? I wasn't sure if there's a different category for post-approval studies. Don't think so, but don't know.

Note: I'm sure you know this better than me, but others might not be aware-- this is just for changes in the official labeling and prescription information, right? Drugs are used off-label all the time without supporting research, or at least high-quality supporting research, and they are generally allowed to be used that way. It's never been clear to me why that should be allowed, but I've taken meds off-label. My wife prescribes meds off-label (I think that most off-label use is in psychiatry but I could def be wrong about that).
 
superrific said:
Are these additional trials labeled stage 3? I wasn't sure if there's a different category for post-approval studies. Don't think so, but don't know.

Note: I'm sure you know this better than me, but others might not be aware-- this is just for changes in the official labeling and prescription information, right? Drugs are used off-label all the time without supporting research, or at least high-quality supporting research, and they are generally allowed to be used that way. It's never been clear to me why that should be allowed, but I've taken meds off-label. My wife prescribes meds off-label (I think that most off-label use is in psychiatry but I could def be wrong about that).
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Yep, trials for new uses of an approved drug are generally still phase 3. In rare cases with extremely compelling data or extenuating circumstances (like, say an imminent bird flu pandemic), a phase 1 or 2 study may suffice to update the official prescribing information. There are phase 4 trials as well, those are typically long-term surveillance trials for approved uses.

Your second point about off-label use is correct as well. From my (admittedly hazy) recollections of our pharmacy law class a decade ago, there aren’t any statutory limits governing prescribing, but the official position of the NC medical and pharmacy boards is that prescribing should be done within established medical practice and with the informed consent of the patient.
 
Huh? said:
He was never an environmental advocate - it's pure mythmaking. He's a legal grifter at his core, and environmentalism was simply his grift of choice. It's worth a read to see how Kennedy isolated Robert Boyle, one of the great environmental writers of the 20th Century, out of the Hudson River Fisherman's Association that Boyle founded.
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I think it’s the mountains of blow and steroids.
 
nycfan said:






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I am an engineer, net even a scientist, and it pisses me off to no end to hear someone like him, who has ZERO training or experience in science, engineering, stats, etc., say something like, "All you really need to do is read some science." He's just like those dumb fucks on FB who said, "Do your own research" on Covid but barely passed general science in high school. He, and they, wouldn't recognize good research if it smacked them in the head with a 2X4. So yes, Mr. Kennedy, don't lecture me about science and I won't lecture you on the law or heroin addiction. God, the sooner these clowns are gone, the better, so they will "quit ruinin' my life!"
 
8992Tiger said:
I am an engineer, net even a scientist, and it pisses me off to no end to hear someone like him, who has ZERO training or experience in science, engineering, stats, etc., say something like, "All you really need to do is read some science." He's just like those dumb fucks on FB who said, "Do your own research" on Covid but barely passed general science in high school. He, and they, wouldn't recognize good research if it smacked them in the head with a 2X4. So yes, Mr. Kennedy, don't lecture me about science and I won't lecture you on the law or heroin addiction. God, the sooner these clowns are gone, the better, so they will "quit ruinin' my life!"
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A lot of what RFK Jr is doing will empower a lot of his buddies in the trial bar to go after American pharma and food giants. I will be interesting to see how the Trump Admin responds when they have those giant companies complaining about Trump enabling copious class actions against them based on government promoted junk science brought to HHS by a member of the very trial bar they disdain.
 
nycfan said:
A lot of what RFK Jr is doing will empower a lot of his buddies in the trial bar to go after American pharma and food giants.
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Really? I mean, they might try but I don't think courts are going to let junk peddlers pass Daubert just because there's a junk peddler at HHS. The lower courts, at least, are wise to these games and are not going to accept Trump's anti-science bullshit.
 
I agree. I believe this is an inside job with the intent of creating discovery for the inevitable class-action lawsuits that follow.
 
superrific said:
Really? I mean, they might try but I don't think courts are going to let junk peddlers pass Daubert just because there's a junk peddler at HHS. The lower courts, at least, are wise to these games and are not going to accept Trump's anti-science bullshit.
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If HHS starts funding junk science, there are plenty of journals that will publish it (e.g. Hindawi) so the peer review criterion should be easier to meet.
 
Huh? said:
My baseball playing, job holding, tax paying autistic son doesn't understand what the Secretary is talking about.
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Since moving uptown, my wife and I have a new friend who is autistic. He is an actuary for an insurance company by day, and works at Spectrum Center as an usher by night. So he works two jobs and pays taxes, while living independently in an uptown apartment. I don’t know about baseball but he does play weekly in a co-ed kickball league. Also, you want him to be on your team if you’re playing music trivia.
 
superrific said:
In a related story, does anyone have a recollection of the FDA suddenly reducing its force by 50% or more?

These fucking idiots have no idea what they are doing.
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Ohhh...they know well what they're doing. Methods may be clumsy...yes; but, the plan is to shrink any benefits of government to middle class and below while allowing big business and wealthy to retain near 100% of profits.
 
superrific said:
Assuming those journals count as legit peer review.

I don't think courts are going to be fooled by this nonsense.
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When you've got Kacsmaryk and Cannon on the bench (and more of their ilk), don't be surprised when populist junk science starts to be admitted in some cases.
 
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