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Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by jmclnx on Thursday December 12, 2024 @11:32AM (#42400624)
What can you say, this is what you get when you cut funding of these agencies over a 20+ year time period. I hear bigger cuts are planned over the next 4 years. If that happens will be a fun times in the US.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by josefritzishere on Thursday December 12, 2024 @11:39AM (#42400691)
I have some concerns.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by Kapura on Thursday December 12, 2024 @12:29PM (#42401217)
Exactly this. The people in power have been nakedly cutting taxes and cutting expenditures in the regulatory state. This is the obvious, foreseeable result, and we cannot let politicians pretend these things will fix themselves thru magic.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by WillPostForFood on Thursday December 12, 2024 @01:22PM (#42401771)
Comments like this are what happen when you are more attached to a narrative that supports your worldview than truth. FDA spending has gone up every year for the last 30 years, growing from under a billion to over 6 billion.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by _DeadFred_ on Thursday December 12, 2024 @03:05PM (#42402845)
What are the statics for workload over that period? Facilities monitored and locations? Drug submissions, volumes, complication of submissions now verses 30 years ago, etc?
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by giantg2 on Thursday December 12, 2024 @01:59PM (#42402169)
I just want to add that the main issue with retaining inspectors is the amount of travel leading to unfavorable work-life balance. Most people do not want to travel 75% of their working time. I imagine the number of people wanting to travel to or relocate to India and China is smaller than those willing to travel or relocate domestically. Then you need qualified people interested in this domain. I image the pool of ideal candidates is extremely small. Recent vacancies are about 10-15%.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by eigen on Thursday December 12, 2024 @10:57PM (#42405806)
> FDA spending has gone up every year for the last 30 years, growing from under a billion to over 6 billion.

doesn't seem like it based on the FDA Fact Sheets. where are you seeing the annual increases?

"The FY 2025 Budget provides a $7.2 billion total program funding level for the U.S. Food and Drug Administration. This includes an overall increase of 7.4 percent or $495 million over the FY 2023 funding level" [1]

"The FY 2024 budget provides a $7.2 billion total program level for FDA. " [2]

"The FY 2023 budget provides an $8.4 billion total program level for FDA." [3]

[1] https://www.fda.gov/media/176923/download

[2] https://www.fda.gov/media/166050/download

[3] https://www.fda.gov/media/157193/download

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by morkalork on Thursday December 12, 2024 @12:42PM (#42401358)
Well, it's a great opportunity for this century's Upton Sinclair at least.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by amateuring on Thursday December 12, 2024 @12:47PM (#42401419)
there's plenty of funding but it's mostly wasted
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by FindingOut on Thursday December 12, 2024 @02:27PM (#42402437)
I've heard this, mostly in relation to discussions of fiscal cuts, but have been unable to find a study quantifying waste or "mostly" wasteful. I don't doubt any large enterprise of humans, in government or private industry, will have instances of waste, even small instances of theft or fraud. It is the quantification ("mostly") and the conclusions thereof (removing delegated authority, either explicitly or via fiscal cuts) that I'm genuinely trying to understand. I'm aware of IG reports of specific instances of waste, but nothing remotely approaching a majority of an agency's funding. Given the history of the "snake oil salesman" era of the US (ca. 1890s-1920s, killing thousands with bogus and impure/junk medicines) that gave rise to the current agency mission, I'm reluctant to find out what social media and an unregulated medical industry can harvest 100 years later.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by boohoo123 on Thursday December 12, 2024 @12:56PM (#42401514)
there's plenty of money there, US govt agencies are completely inept. They cant fire anyone so no one cares if they do their job well or not. You have 5 employees who do what 1 could do, and its always someone else's problem, so the the can is just kicked further down the road. If you think the govt needs more money i encourage to go work for them and see the waste and laziness yourself.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by jjulius on Thursday December 12, 2024 @01:01PM (#42401569)
>You have 5 employees who do what 1 could do...

Do you have a specific example that fits this description that you could point to?

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by boohoo123 on Thursday December 12, 2024 @02:20PM (#42402368)
My job requires me to interact with HHS basically weekly and everyone I talk to has no idea what the heck is going on and constantly sends me over to someone who also knows nothing. And this department is the one who makes the rules for healthcare, scary I know. As for the ratio given you can see it in in the increase of federal workers over the years. Government is the only sector that didnt have a plateau effect with the birth of technology. Now the 5:1 ratio is completely arbitrary but the point still stands.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by jjulius on Thursday December 12, 2024 @02:42PM (#42402607)
I'm sure that those interactions are frustrating and are very hard to deal with. I'm sorry that you have to take on that stress so frequently.

That said, someone being unable to answer a question isnt necessarily indicative of a situation where "five people are doing the job of one person". Your example is very circumstantial (and is a scenario found frequently within the private sector, as well).

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by gonzoflip on Thursday December 12, 2024 @01:05PM (#42401608)
Where did you get the idea that their funding has been cut? Their appropriations have been steadily increasing for most years over the time frame you call out. In addition to the the congressionally appropriated funds, their "user fees" income has grown significantly to the point where it makes up a very significant portion of their total budget. The impact of almost half of their income coming from the orgs they are supposed to be regulating is _in my opinion_ a better place to look for them overlooking violations from their "users". https://crsreports.congress.gov/product/pdf/R/R44576
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by woodruffw on Thursday December 12, 2024 @01:26PM (#42401814)
It's worth noting that the "user fees" component of the FDA's budget isn't growing primarily because the FDA has increased those fees, but because Congress have consistently authorized new categories of feeds corresponding to changes in the medical environment. That paints a very different (although incomplete) picture than the FDA raking in cash: they're collecting fees to compensate for a larger regulatory picture, including new drug classes and categories developed over the last 30 years.

This is broken down on the FDA's website[1].

[1]: https://www.fda.gov/industry/fda-user-fee-programs/fda-user-...

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by MichaelZuo on Thursday December 12, 2024 @02:48PM (#42402660)
Yeah in real terms, the total budget divided over the total number of specific cases/inquiries/complaints/mandates/etc… has shrunk enormously.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by Spooky23 on Thursday December 12, 2024 @02:21PM (#42402375)
Federal agencies don’t just get $X billion to be spent at the direction of the agency executive. Each program gets funded at a very low level.

I did some contracting for a federal agency, the area I was meeting with was a hot area… Aeron chairs, nice office spaces, new computers.

One time we had to cut through an office area on the other side of the floor that was being starved. 1970s orange carpets, DOS computers, people who looked like they worked in a coal mine.

Same agency, different budgets. IRS is the famous example, Republicans when they control the house always starve the enforcement division as much as possible.

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by s1artibartfast on Thursday December 12, 2024 @04:54PM (#42403811)
This is the nature of government agencies. Budgets are set by inertia, not need or output.

When I worked for an agency, there was always a mad rush at the end of the year spending millions on useless crap. The rationale was that any budget surplus would be reallocated and cut from next years budget, putting future programs at risk.

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by s1artibartfast on Thursday December 12, 2024 @01:25PM (#42401809)
Can you explain why you think user fees are a conflict of interest?

My understanding is that the FDA gets paid either way and have a monopoly on approval. It's not like the users will go somewhere else if they received an unfavorable ruling.

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by AcerbicZero on Thursday December 12, 2024 @03:25PM (#42403010)
Where did they get that idea? They made it up to fit their narrative. Shocking, I know.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by giantg2 on Thursday December 12, 2024 @01:52PM (#42402101)
"What can you say, this is what you get when you cut funding of these agencies over a 20+ year time period."

Actually, this is mostly an issue with process. Covid shutdowns caused a huge backlog. Offshore manufacturing gets notifications of planned visits versus unannounced visits for onshore facilities. Sure, every org will say it can do more with a bigger budget. But more money for inspectors will do little to retain them when some of the biggest complaints are the travel requirements leading to reduced work-life balance.

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by BadHumans on Thursday December 12, 2024 @01:55PM (#42402131)
You make it sound like you can't use money to hire more inspectors so the burden is reduced.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by giantg2 on Thursday December 12, 2024 @03:57PM (#42403242)
You really think that will help? Even if you double staffed it, you're still looking at about 40% travel. People with lives and families don't want that. You could overstaff by 15% so attrition doesn't hurt as much, but there's a whole GAO report you could look up.
Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by BadHumans on Thursday December 12, 2024 @04:58PM (#42403842)
> You really think that will help?

Yes.

Re:The FDA Hasn't Inspected This Drug Factory After 7 Recall... by 015a on Thursday December 12, 2024 @02:29PM (#42402445)
The FDA's funding has increased every single year for the past 10 years, and possibly longer. Try again.