Anonymous wrote:I just read an interview with Kennedy where some were fired inadvertently. He kept calling it the "Doge" cuts. What?! He is the Secretary. Ultimately, they are his cuts.

do you think Kennedy understands anything about anything? He’s literally brain damaged and can’t really talk.

Anonymous wrote:I just read an interview with Kennedy where some were fired inadvertently. He kept calling it the "Doge" cuts. What?! He is the Secretary. Ultimately, they are his cuts.

Yup. They even left doge in the url of the press release announcing the cuts. Everyone knows Kennedy just looked at the list for two seconds, saw some vaccine offices were on it, then said yes.

God forbid he do his job. He’s too busy jabbing himself with off-label testosterone and posting on X to bother though.

I just read an interview with Kennedy where some were fired inadvertently. He kept calling it the "Doge" cuts. What?! He is the Secretary. Ultimately, they are his cuts.

Anonymous wrote:

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

What on earth is your source. User fees are statutory they can’t disappear in weeks.

Industry could sue the fda though, much as states just sued the NIH.

Read the link above.

User fees are statutory ONLY if FDA uses a certain level of appropriations..If FDA does not, then it is illegal for FDA to collet user fees. Due to all of the firings and retirments and hiring freezes, it is possible FDA may fall below the appropriations amount, which means FDA would have to refund user fees and wouldn't be able to collect. They would be zero money for reviewers. FDA woulbasicslly end.

Again, this is hypothetical, but the risk is very real. Read the extensive article above.

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

What on earth is your source. User fees are statutory they can’t disappear in weeks.

Industry could sue the fda though, much as states just sued the NIH.

Anonymous wrote:Actually, he just posted it:

https://www.agencyiq.com/blog/following-layoffs-the-future-of-fdas-user-fee-programs-is-in-extreme-jeopardy/

This makes me panic.

- private biotech/pharma field.

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

They’ve fired many of the FDA scientists and high level experts already. Agreed it can get much worse but if you feel safe now when you take a pill or use a medical device, you won’t in 2 years once all the FDA experts and oversight staff are gone.

Based on this news, it could get much worse. I'm talking about FDA basically no longer existing. Worst part of all is that DOGE and RFK probably never intended this to happen. They simply had no idea their actions had unintended consequences.

What? Yeah, they did. Who do you think is doing this hack job?

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

They’ve fired many of the FDA scientists and high level experts already. Agreed it can get much worse but if you feel safe now when you take a pill or use a medical device, you won’t in 2 years once all the FDA experts and oversight staff are gone.

Based on this news, it could get much worse. I'm talking about FDA basically no longer existing. Worst part of all is that DOGE and RFK probably never intended this to happen. They simply had no idea their actions had unintended consequences.

What makes you think they didn't intend for this to happen?

Because the collapse is so catastrophic and rapid they would have no time for anything else, including privatization. This is overnight evaporation of FDA. Nothing to replace it. It shows stupidity, not planning.

Actually, he just posted it:

https://www.agencyiq.com/blog/following-layoffs-the-future-of-fdas-user-fee-programs-is-in-extreme-jeopardy/

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

They’ve fired many of the FDA scientists and high level experts already. Agreed it can get much worse but if you feel safe now when you take a pill or use a medical device, you won’t in 2 years once all the FDA experts and oversight staff are gone.

Based on this news, it could get much worse. I'm talking about FDA basically no longer existing. Worst part of all is that DOGE and RFK probably never intended this to happen. They simply had no idea their actions had unintended consequences.

What makes you think they didn't intend for this to happen?

Anonymous wrote:

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

Can you post this news? I will like to see what it says because this is not how user fees work.

The news is paywalled, but the author tweeted about it:

Also read #2 and 3 from this LinkedIn person who discussed this issue weeks ago:

https://www.linkedin.com/posts/ellen-werble-28820368_shutdown-and-fda-spending-here-is-what-i-activity-7305954772912689152-gB23

Then go read the stipulations on user fees that must be met.

It is a potential catastrophic, existential threat to FDA as we know it. Category 10 shit hurricane for FDA of what Mr. Gaffney writes about happens. No more user fees means billions in lost funds. Which means no more reviewers. Which means collapse of FDA and biotech/pharma in America.

DOGE and RFK probably had no idea about the triggers for PDUFA and all do the other user fees before they started slashing. Law of unintended consequences. Now there may be no one left to ensure oversight over safe foods, drugs, and devices. Catastrophic failure could be imminent unless there is an emergency step in to change the law or emergency funds for billions are provided.

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

Can you post this news? I will like to see what it says because this is not how user fees work.

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

They’ve fired many of the FDA scientists and high level experts already. Agreed it can get much worse but if you feel safe now when you take a pill or use a medical device, you won’t in 2 years once all the FDA experts and oversight staff are gone.

Based on this news, it could get much worse. I'm talking about FDA basically no longer existing. Worst part of all is that DOGE and RFK probably never intended this to happen. They simply had no idea their actions had unintended consequences.

This really will send us into developing nation status.

Anonymous wrote:

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

They’ve fired many of the FDA scientists and high level experts already. Agreed it can get much worse but if you feel safe now when you take a pill or use a medical device, you won’t in 2 years once all the FDA experts and oversight staff are gone.

Based on this news, it could get much worse. I'm talking about FDA basically no longer existing. Worst part of all is that DOGE and RFK probably never intended this to happen. They simply had no idea their actions had unintended consequences.

Anonymous wrote:Just read very disturbing published news. User fees are at extreme risk. FDA may be dead in a matter of weeks. If that happens it will be catastrophic for biotech and pharma. Mass layoffs and FDA may basically cease to exist. No one will be left to monitor for food and drug safety.

They’ve fired many of the FDA scientists and high level experts already. Agreed it can get much worse but if you feel safe now when you take a pill or use a medical device, you won’t in 2 years once all the FDA experts and oversight staff are gone.