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[quote=Anonymous][quote=Anonymous][quote=Anonymous]FDA is always short-staffed. Approvals are sometimes forced against the FDA scientists' recommendations, because some corporations are really good at applying pressure.
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How do they do it?[/quote]

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. [/quote]

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