5 ms·

So the FDA has 16,000 employees, 10 of which work in the FOIA office. That is the level of commitment to openness by a vital government agency.

bumby 5y ago
How many do you think are appropriate? Add too many and people will be complaining about bureaucratic bloat. Besides, the number of civil servants doesn't mean they can't hire contractors to help, but putting those contracts out for bid is not an instantaneous effort.
- parkingrift 5y ago
  Speaking of bureaucratic bloat... the FDA has 4,659 people working in "regulatory affairs" and 956 working in "family smoking prevention." That is in addition to the other 11,000 civilian employees and 1,100 military employees. Apparently the FDA spends 8.5 million hours per year on "regulatory affairs." Boy I'd like to see that hourly breakdown.
  - bumby 5y ago
    This is to my point. There are a ton of single issues that some group is going to say needs to be a higher priority. I was interested so I looked up the FDA's regulatory affairs [1], which "conducts sample analyses of regulated products and reviews imported products offered for entry into the United States" This seems pretty inline with their core mission so I'm not surprised they spend a lot of time on it. [1]https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs https://www.fda.gov/about-fda/fda-organization/office-regula...
  - kube-system 5y ago
    Those are parts of their core purpose, of course they spend a lot of resources on them. They're a regulatory organization that regulates tobacco products. Redacting documents, by contrast, is not a core mission of theirs.
  - avs733 5y ago
    There was another comment about the already released documents being taken wildly out of context and flat out lied about by anti-vaccine idiots. This is the same type of thing honestly. The presumption that you have that you know what these numbers mean, entirely out of any meaningful context. Let me sincerely ask, when you wrote this what did you assume someone in regulatory affairs at FDA did? What motivated you to think that number was too large? Here is their website. Is this what you thought they did? https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs https://www.fda.gov/about-fda/fda-organization/office-regula...
    - parkingrift 5y ago
      > Let me sincerely ask, when you wrote this what did you assume someone in regulatory affairs at FDA did? I assume it’s like most government jobs. 70% waste.
      - bumby 5y ago
        Is this actually based on something or just venting? Having worked on both public and private sides, I anecdotally saw roughly equal amounts of waste.
        avs733 5y ago
        simpler approach here is they are unwilling or unable to find a useful basis for the argument. They haven't considered what these people do, just assumed there are to many of them without considering it.
  - elliekelly 5y ago
    They’re a regulatory agency. If they weren’t dedicating a large amount of time to regulatory affairs it would be a problem.
- temac 5y ago
  Not GP but 100. If people complain about "bloat" for less than 1% they can simply be ignored.
  - bumby 5y ago
    I think I'd disagree. That's 1% for one tangential aspect of operations. With nearly 3MM federal employees, that's 30k just for FOIA requests. That's a single pet issue. For everyone who thinks transparency is important enough to have 1% of total employees allocated to it, there's going to be many more pet issues people would feel the same way about. I would prefer they look at improving their processes for complying in a more efficient manner rather than just layering more employees (and legacy costs that come with them) onto the solution.
- tagoregrtst 5y ago
  Enough to be compliant with the law. The FDA’s original response to finish by the end of the century. Thats not a serious answer.
  - bumby 5y ago
    I agree with you in principle but may disagree in the mechanism. Let's assume for a moment that the FDA's rate of review is accurate (for the record, I think they are severely low-balling it). They would need 100x the staff to review the records in time to meet the court order. Keep in mind the number of documents may be unique because of the scale of the pandemic (maybe somebody can fact check that). Knowing how difficult it is get rid of government employees, does it make sense to hire that many people for a once-in-a-century one-off event and then...what? Have them sit around and do nothing afterwards? I think trying to fit someone into a later role they weren't hired for is a terrible choice in my experience. But you say, "so what, it's the law"...so they're hired anyways. Maybe you get lucky and they're only hired as temp positions. Do you know how long the federal hiring practice takes? Because it's the government, most jobs have legalities around how they are posted, how long they need to be advertised, sometimes they require extending the ads internally first etc. due to union issues. If the job requires some sort of board approval, it may take months even after the selection is made, and they haven't even been trained yet. If you say, "well, all that can be fixed by just hiring contractors." The bid process runs into the same time-lag due to it being a government contract and needing to be open-and-above board. "Well, just use an emergency no-bid contract." Now you're running into all kinds of legalities to avoid political cronyism. The point being, it isn't nearly as simple as many seem to think. IMO the solution isn't "just hire more people to be compliant with the law" it's figuring out why your review process is so inefficient to only produce 50 reviewed/approved pages per month per employee. Really!? You can only average a little over a page-and-a-half of review per day? I think they need to hire an industrial engineer to revise the process, not simply hire more people. 100x'ing the number of people into what appears to be a broken process will likely make things worse.
    - tagoregrtst 5y ago
      I work as a contractor to the government because Fed hiring is nearly impossible in my little corner. It took me months to get a $1000 piece of equipment I need to start my job. So, I know how long it takes and you’re right. That being said, Ive taken all the FOIA trainings, and all the “blah blah” about the public’s right to know. 500 pages a month is not a serious answer, its dodging. EDIT: “ Let's assume for a moment that the FDA's rate of review is accurate (for the record, I think they are severely low-balling it)” significantly low balling it indeed
jimbob45 5y ago
It's a Titanic problem - too many people, not enough boats. Except here, it's too many projects, not enough funding. Sure, this sucks right now but who's to say that we wouldn't be on board with the tradeoff if we knew what otherwise wouldn't have received funding?
- dublin 5y ago
  It's worth noting (READ IT!) that the court order specifically calls out that given the urgency of the current disease situation and political and public health trust issues, it is the Court's opinion that there is almost nothing the FDA has to do that could be MORE important. The FDA, at the behest of Pfizer, et al, have been deliberately obstructive in making publicly available drug trial information that is clearly required by both law and rule. All parties involved knew they needed to publish that info, and have steadfastly refused to do what the law requires them to do. If I were the judge, I'd have given them 90 days to turn over everything, and thrown the head of the FDA and the CEOs in jail for contempt until all those records are indeed published. IMO, they got off really easy.

bumby 5y ago

How many do you think are appropriate? Add too many and people will be complaining about bureaucratic bloat. Besides, the number of civil servants doesn't mean they can't hire contractors to help, but putting those contracts out for bid is not an instantaneous effort.

parkingrift 5y ago
Speaking of bureaucratic bloat... the FDA has 4,659 people working in "regulatory affairs" and 956 working in "family smoking prevention." That is in addition to the other 11,000 civilian employees and 1,100 military employees. Apparently the FDA spends 8.5 million hours per year on "regulatory affairs." Boy I'd like to see that hourly breakdown.
- bumby 5y ago
  This is to my point. There are a ton of single issues that some group is going to say needs to be a higher priority. I was interested so I looked up the FDA's regulatory affairs [1], which "conducts sample analyses of regulated products and reviews imported products offered for entry into the United States" This seems pretty inline with their core mission so I'm not surprised they spend a lot of time on it. [1]https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs https://www.fda.gov/about-fda/fda-organization/office-regula...
- kube-system 5y ago
  Those are parts of their core purpose, of course they spend a lot of resources on them. They're a regulatory organization that regulates tobacco products. Redacting documents, by contrast, is not a core mission of theirs.
- avs733 5y ago
  There was another comment about the already released documents being taken wildly out of context and flat out lied about by anti-vaccine idiots. This is the same type of thing honestly. The presumption that you have that you know what these numbers mean, entirely out of any meaningful context. Let me sincerely ask, when you wrote this what did you assume someone in regulatory affairs at FDA did? What motivated you to think that number was too large? Here is their website. Is this what you thought they did? https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs https://www.fda.gov/about-fda/fda-organization/office-regula...
  - parkingrift 5y ago
    > Let me sincerely ask, when you wrote this what did you assume someone in regulatory affairs at FDA did? I assume it’s like most government jobs. 70% waste.
    - bumby 5y ago
      Is this actually based on something or just venting? Having worked on both public and private sides, I anecdotally saw roughly equal amounts of waste.
      - avs733 5y ago
        simpler approach here is they are unwilling or unable to find a useful basis for the argument. They haven't considered what these people do, just assumed there are to many of them without considering it.
- elliekelly 5y ago
  They’re a regulatory agency. If they weren’t dedicating a large amount of time to regulatory affairs it would be a problem.
temac 5y ago
Not GP but 100. If people complain about "bloat" for less than 1% they can simply be ignored.
- bumby 5y ago
  I think I'd disagree. That's 1% for one tangential aspect of operations. With nearly 3MM federal employees, that's 30k just for FOIA requests. That's a single pet issue. For everyone who thinks transparency is important enough to have 1% of total employees allocated to it, there's going to be many more pet issues people would feel the same way about. I would prefer they look at improving their processes for complying in a more efficient manner rather than just layering more employees (and legacy costs that come with them) onto the solution.
tagoregrtst 5y ago
Enough to be compliant with the law. The FDA’s original response to finish by the end of the century. Thats not a serious answer.
- bumby 5y ago
  I agree with you in principle but may disagree in the mechanism. Let's assume for a moment that the FDA's rate of review is accurate (for the record, I think they are severely low-balling it). They would need 100x the staff to review the records in time to meet the court order. Keep in mind the number of documents may be unique because of the scale of the pandemic (maybe somebody can fact check that). Knowing how difficult it is get rid of government employees, does it make sense to hire that many people for a once-in-a-century one-off event and then...what? Have them sit around and do nothing afterwards? I think trying to fit someone into a later role they weren't hired for is a terrible choice in my experience. But you say, "so what, it's the law"...so they're hired anyways. Maybe you get lucky and they're only hired as temp positions. Do you know how long the federal hiring practice takes? Because it's the government, most jobs have legalities around how they are posted, how long they need to be advertised, sometimes they require extending the ads internally first etc. due to union issues. If the job requires some sort of board approval, it may take months even after the selection is made, and they haven't even been trained yet. If you say, "well, all that can be fixed by just hiring contractors." The bid process runs into the same time-lag due to it being a government contract and needing to be open-and-above board. "Well, just use an emergency no-bid contract." Now you're running into all kinds of legalities to avoid political cronyism. The point being, it isn't nearly as simple as many seem to think. IMO the solution isn't "just hire more people to be compliant with the law" it's figuring out why your review process is so inefficient to only produce 50 reviewed/approved pages per month per employee. Really!? You can only average a little over a page-and-a-half of review per day? I think they need to hire an industrial engineer to revise the process, not simply hire more people. 100x'ing the number of people into what appears to be a broken process will likely make things worse.
  - tagoregrtst 5y ago
    I work as a contractor to the government because Fed hiring is nearly impossible in my little corner. It took me months to get a $1000 piece of equipment I need to start my job. So, I know how long it takes and you’re right. That being said, Ive taken all the FOIA trainings, and all the “blah blah” about the public’s right to know. 500 pages a month is not a serious answer, its dodging. EDIT: “ Let's assume for a moment that the FDA's rate of review is accurate (for the record, I think they are severely low-balling it)” significantly low balling it indeed

jimbob45 5y ago

It's a Titanic problem - too many people, not enough boats. Except here, it's too many projects, not enough funding. Sure, this sucks right now but who's to say that we wouldn't be on board with the tradeoff if we knew what otherwise wouldn't have received funding?

dublin 5y ago
It's worth noting (READ IT!) that the court order specifically calls out that given the urgency of the current disease situation and political and public health trust issues, it is the Court's opinion that there is almost nothing the FDA has to do that could be MORE important. The FDA, at the behest of Pfizer, et al, have been deliberately obstructive in making publicly available drug trial information that is clearly required by both law and rule. All parties involved knew they needed to publish that info, and have steadfastly refused to do what the law requires them to do. If I were the judge, I'd have given them 90 days to turn over everything, and thrown the head of the FDA and the CEOs in jail for contempt until all those records are indeed published. IMO, they got off really easy.