3 ms·

“much of the regulation is based on good faith simply because the manpower required to verify everything made would be massive” This is where I wish there were

by ianai 7y ago

“much of the regulation is based on good faith simply because the manpower required to verify everything made would be massive” This is where I wish there were more tolerance for enough government spending to employ as many people as it would take to test properly. We’re talking about medication being used multiple times a day for long term-amongst many uses.

mirimir 7y ago
The FDA has been downsized many times over the past three decades. So what we're seeing here is not at all unexpected.
- refurb 7y ago
  The FDA’s budget is more than 6x what it was in 1992.[1]. An increased every year since then. What do you mean downsized? [1]https://www.everycrsreport.com/reports/R44576.html#_Toc8219812 https://www.everycrsreport.com/reports/R44576.html#_Toc82198...
  - mirimir 7y ago
    That's no inflation adjusted. And it's also not adjusted for processing load. But it does show the greatly increased role of user fees, which I gather has facilitated regulatory capture.
    - refurb 7y ago
      Inflation hasn’t been 600% since 1992. Not sure what processing load is, but if they’re asked to do more that could be an issue, but I wouldn’t call it a cut.
      - mirimir 7y ago
        I do remember reading about cuts in FDA resources. As an excuse for why they'd missed so many violations. Checking, I see that it was Reagan era cuts.[0] So the timeline that you cited begins in 1992, which was probably the minimum funding level.[1,2] Also, Hatch-Waxman was approved in 1984, which increased the workload considerably. And then there was the first generic drug scandal in the late 80s. That's what I was thinking of. 0) https://academic.oup.com/shm/article-abstract/29/1/202/2472270?redirectedFrom=fulltext https://academic.oup.com/shm/article-abstract/29/1/202/24722... 1) https://www.everycrsreport.com/reports/R44576.html#_Toc8219812 https://www.everycrsreport.com/reports/R44576.html#_Toc82198... 2) https://sci-hub.tw/https://doi.org/10.1093/shm/hkv106 https://sci-hub.tw/https://doi.org/10.1093/shm/hkv106

by ianai 7y ago

mirimir 7y ago

The FDA has been downsized many times over the past three decades. So what we're seeing here is not at all unexpected.

refurb 7y ago
The FDA’s budget is more than 6x what it was in 1992.[1]. An increased every year since then. What do you mean downsized? [1]https://www.everycrsreport.com/reports/R44576.html#_Toc8219812 https://www.everycrsreport.com/reports/R44576.html#_Toc82198...
- mirimir 7y ago
  That's no inflation adjusted. And it's also not adjusted for processing load. But it does show the greatly increased role of user fees, which I gather has facilitated regulatory capture.
  - refurb 7y ago
    Inflation hasn’t been 600% since 1992. Not sure what processing load is, but if they’re asked to do more that could be an issue, but I wouldn’t call it a cut.
    - mirimir 7y ago
      I do remember reading about cuts in FDA resources. As an excuse for why they'd missed so many violations. Checking, I see that it was Reagan era cuts.[0] So the timeline that you cited begins in 1992, which was probably the minimum funding level.[1,2] Also, Hatch-Waxman was approved in 1984, which increased the workload considerably. And then there was the first generic drug scandal in the late 80s. That's what I was thinking of. 0) https://academic.oup.com/shm/article-abstract/29/1/202/2472270?redirectedFrom=fulltext https://academic.oup.com/shm/article-abstract/29/1/202/24722... 1) https://www.everycrsreport.com/reports/R44576.html#_Toc8219812 https://www.everycrsreport.com/reports/R44576.html#_Toc82198... 2) https://sci-hub.tw/https://doi.org/10.1093/shm/hkv106 https://sci-hub.tw/https://doi.org/10.1093/shm/hkv106