3 ms·

I agree, I think the statement is ambiguous. 1% of all products (e.g. one pill from every bottle of 100 pills) being tested seems like plenty. 1% of shipments

I agree, I think the statement is ambiguous. 1% of all products (e.g. one pill from every bottle of 100 pills) being tested seems like plenty. 1% of shipments (1 out of 100 shipments is sampled) seems insufficient.

RussianCow 7y ago
Even 1% shipments would be okay, IMO. I interpreted it as "99% of drug products never get inspected", which is way worse.
- ianai 7y ago
  It’s more like the later than I’m comfortable with tolerating.
refurb 7y ago
Very ambiguous. Generally how it works is you submit a proposed purity level to the FDA, with rationale and backup by your own validated analyses. The FDA dives into it and says “this is reasonable” or “this won’t work” or “based on the chemistry, you need to test for X also”. Then they require you to “release” any product you make, showing that it conforms to the agreed upon purity. If it fails, they expect you to follow up and figure out why. Note, most of this is done in good faith - the FDA isn’t repeating the science in a lab, but they pay enough attention that if you’re making things up, it’ll be apparent in the data. The CMC (chemistry manufacturing controls) section of the NDA can be hundreds of pages long. When it comes to inspections, they are typically random (but if you have a bad track record they happen more often). They can happen any time and they’ll look at all your processes, not just for a specific drug. Don’t have a record that you cleaned your equipment between runs? That’s a paddlin’. Repeatedly run tests until you get a “pass” result? Yeah, your product will get banned from importation. But yes, much of the regulation is based on good faith simply because the manpower required to verify everything made would be massive.
- 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
s1artibartfast 7y ago
The think the accurate statement is that 1% or product lines have had a shipment sampled. The FDA is not in the business of performing QA testing, that is the job of the manufacturer. It is better to think of them as a legislative body.
- AstralStorm 7y ago
  Maybe a special duty office for this should be created. (Like for meat and meat products in EU.)

RussianCow 7y ago

Even 1% shipments would be okay, IMO. I interpreted it as "99% of drug products never get inspected", which is way worse.

ianai 7y ago
It’s more like the later than I’m comfortable with tolerating.

refurb 7y ago

Very ambiguous. Generally how it works is you submit a proposed purity level to the FDA, with rationale and backup by your own validated analyses. The FDA dives into it and says “this is reasonable” or “this won’t work” or “based on the chemistry, you need to test for X also”. Then they require you to “release” any product you make, showing that it conforms to the agreed upon purity. If it fails, they expect you to follow up and figure out why. Note, most of this is done in good faith - the FDA isn’t repeating the science in a lab, but they pay enough attention that if you’re making things up, it’ll be apparent in the data. The CMC (chemistry manufacturing controls) section of the NDA can be hundreds of pages long. When it comes to inspections, they are typically random (but if you have a bad track record they happen more often). They can happen any time and they’ll look at all your processes, not just for a specific drug. Don’t have a record that you cleaned your equipment between runs? That’s a paddlin’. Repeatedly run tests until you get a “pass” result? Yeah, your product will get banned from importation. But yes, much of the regulation is based on good faith simply because the manpower required to verify everything made would be massive.

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

s1artibartfast 7y ago

The think the accurate statement is that 1% or product lines have had a shipment sampled. The FDA is not in the business of performing QA testing, that is the job of the manufacturer. It is better to think of them as a legislative body.

AstralStorm 7y ago
Maybe a special duty office for this should be created. (Like for meat and meat products in EU.)