Anonymous wrote:My office at CDER/FDA canceled all open positions since the beginning of October.

Do you know why? Just curious of the timing…

Anonymous wrote:

Anonymous wrote:FDA is always short-staffed. Approvals are sometimes forced against the FDA scientists' recommendations, because some corporations are really good at applying pressure.

How do they do it?

I’m curious to know the actual mechanisms by which companies apply pressure. I ask because I just don’t see a lot of mechanisms for them to do it. (And I don’t know where RFK is going—I’m talking about the current FDA.)

There’s no internal FDA incentive for managers to make positive regulatory decisions, just to make fast ones. The performance metric is speed, not results.

There are good FDA consultants and attorneys, but the best they can do is make a convincing case. They don’t have leverage to force FDA to do anything. Trade associations typically advocate on behalf of a whole industry, not a single company.

People upthread have mentioned user fees but those are like vehicle emission inspection fees; everyone pays them and plenty of submissions are rejected anyway.

I’ve heard of companies calling their representatives but again, I don’t know how that really helps.

I think the only real lever to influence FDA is public sentiment (like with the COVID vaccine.) Or having a lot of other professional societies and well-known physicians advocate for a product.

Anonymous wrote:The fees are seen as means of corruption. RFKJr speaks out about that, not a favored agency.

This is my thought. I have 2 family members who work there and have told us they are safe because of the fees but nobody is safe. I’m assuming they are really just trying not to dwell on the possibility because it’s beyond their control.

My office at CDER/FDA canceled all open positions since the beginning of October.

Anonymous wrote:The fees are seen as means of corruption. RFKJr speaks out about that, not a favored agency.

Not sure what you want anyone to do about it. The whole reason the fees exist is because Congress wouldn't fund FDA adequately before. Innovation and treatments for sick people were stuck in regulatory limbo for years because they simply didn't have money for staff. They also had to keep submitting massive submissions via paper because FDA simply don't have money to upgrade its IT infrastructure.

Sure, RFK can kill the fees, but unless he finds billions of dollars in funding, he will learn same the history lesson we already had as before. I'd actually agree with getting rid of fees, but congress will always play political games with it and it'll never be stable so we will be right back to square one. It'll also be only a matter of time until screaming angry mommy bloggers who have kids with terrible disease are pissed off at why there are treatments stuck at FDA that aren't being reviewed. Oops sorry, they just don't have the staff because Congress didn't provide funding.

The FDA got over 1 million submissions for vaping products alone. That's not even counting any drugs, devices, generics, food, veterinary medicines, etc. That's just to give you a sense of the mammoth volume it deal with. They can cut their finding mechanisms at their own peril. Without replacement, huge sectors of the economy will get slammed. FDA has to oversee 20% of the entire US GDP.