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My intuition is that factory inspections should be self-funding, either via tax/fee levies on manufacturers or via fines on factories which fail inspections. H

My intuition is that factory inspections should be self-funding, either via tax/fee levies on manufacturers or via fines on factories which fail inspections. How is there a shortage of inspectors? Does FDA not have the authority to fine factories which fail inspections? I have also heard that getting a factory certified as clean for GMP is a huge process. How are foreign factories entering the market if they have never been inspected?

bluGill 2y ago
If inspections are self funding you are not inspecting the good guys enough to ensure they don't become bad, or your fines are too low and so offenders are just calling paying the fine a cost of doing business without changing anything.
- JumpCrisscross 2y ago
  > If inspections are self funding you are not inspecting the good guys enough to ensure they don't become bad Emissions inspections and financial audits are self funding. You pay to get the test because you have to.
  - bluGill 2y ago
    Sometimes they are self funding. In the case you listed they are. however there are lots of different inspections and they all have different funding.
RachelF 2y ago
The FDA has to give the factories 90 days notice of an upcoming inspection.
- hiatus 2y ago
  That is crazy. Restaurants don't get any notice for health inspection, why are drug factories treated differently when the risks are larger? edit: The parent comment is flat-out incorrect. Not sure where you are getting your information from. > FDA inspections are generally unannounced, with a few exceptions. From FDA's "What to expect during an FDA inspection" https://www.fda.gov/media/142762/download https://www.fda.gov/media/142762/download
  - hyeonwho4 2y ago
    As of 2022, foreign inspections were generally preannounced, and the GAO identified the need for a "pilot plan" for surprise foreign inspections: https://www.fiercepharma.com/pharma/fda-must-solidify-plan-for-unannounced-foreign-inspections-rev-up-hiring-overseas https://www.fiercepharma.com/pharma/fda-must-solidify-plan-f...
    - hiatus 2y ago
      I appreciate the additional information, though to the point it does not seem that FDA is _required_ to give any notice before an inspection.
eitally 2y ago
Inspectors need terminal degrees and the pay doesn't match what they typically get in industry. The same is true for veterinarians employed by USDA to do ranch & meat packing inspections.
stackskipton 2y ago
FDA has trouble hiring inspectors due to requirement of advanced degree with low pay. FDA has authority to fine factories but like most things right now, these drugs are only cheap source of medicine for many so Medicare/Medicaid is leaning not to cut it off. Inspecting Foreign Factories is obviously much harder even cost aside because inspectors don't want to do it and the person spends almost 4-6 days traveling.

bluGill 2y ago

If inspections are self funding you are not inspecting the good guys enough to ensure they don't become bad, or your fines are too low and so offenders are just calling paying the fine a cost of doing business without changing anything.

JumpCrisscross 2y ago
> If inspections are self funding you are not inspecting the good guys enough to ensure they don't become bad Emissions inspections and financial audits are self funding. You pay to get the test because you have to.
- bluGill 2y ago
  Sometimes they are self funding. In the case you listed they are. however there are lots of different inspections and they all have different funding.

RachelF 2y ago

The FDA has to give the factories 90 days notice of an upcoming inspection.

hiatus 2y ago
That is crazy. Restaurants don't get any notice for health inspection, why are drug factories treated differently when the risks are larger? edit: The parent comment is flat-out incorrect. Not sure where you are getting your information from. > FDA inspections are generally unannounced, with a few exceptions. From FDA's "What to expect during an FDA inspection" https://www.fda.gov/media/142762/download https://www.fda.gov/media/142762/download
- hyeonwho4 2y ago
  As of 2022, foreign inspections were generally preannounced, and the GAO identified the need for a "pilot plan" for surprise foreign inspections: https://www.fiercepharma.com/pharma/fda-must-solidify-plan-for-unannounced-foreign-inspections-rev-up-hiring-overseas https://www.fiercepharma.com/pharma/fda-must-solidify-plan-f...
  - hiatus 2y ago
    I appreciate the additional information, though to the point it does not seem that FDA is _required_ to give any notice before an inspection.

eitally 2y ago

Inspectors need terminal degrees and the pay doesn't match what they typically get in industry. The same is true for veterinarians employed by USDA to do ranch & meat packing inspections.

stackskipton 2y ago

FDA has trouble hiring inspectors due to requirement of advanced degree with low pay. FDA has authority to fine factories but like most things right now, these drugs are only cheap source of medicine for many so Medicare/Medicaid is leaning not to cut it off. Inspecting Foreign Factories is obviously much harder even cost aside because inspectors don't want to do it and the person spends almost 4-6 days traveling.