4 ms·

You don’t mention quality controls. What should FDA do if upon said random testing there are concerns? How can they and/or the manufacturer trace the causes wit

by robg 3y ago

You don’t mention quality controls. What should FDA do if upon said random testing there are concerns? How can they and/or the manufacturer trace the causes without documentation?

A_D_E_P_T 3y ago
> What should FDA do if upon said random testing there are concerns? Destroy or return the entire batch, depending on the level of concern. > How can they and/or the manufacturer trace the causes without documentation? That shouldn't be the FDA's concern. The FDA's concern should begin and end with the quality of the actual drugs that are entering the US supply chain. The drugs are things in themselves and can be tested as such -- without regard to where they came from or exactly how they were made.
- robg 3y ago
  A random sample by definition isn’t the entire batch, so how would you define ‘batch’ without documentation? The FDA would force recall on the entire product entering the country? Until how many samples are cleared?
  - A_D_E_P_T 3y ago
    Pretty simple. Most cheap generic drugs are imported by the containerload, so simply create an arbitrary "batch" from each instance of importation. If the manufacturer is decent and has its own batch number, then the label could read "Manufacturer batch: XXXX FDA Import of Record batch: YYYY." Drugs that are imported in more specialized ways -- e.g. by small-volume refrigerated air freight -- are, as a general rule, far more expensive and batches are correspondingly smaller. The above paradigm would still work, where each importation instance is, for the FDA's purposes, a batch. Testing fees, which shouldn't amount to more than a few thousand bucks per import, can be the responsibility of the importer -- so as to dissuade importers from receiving small batch after small batch.
    - robg 3y ago
      So you treat each subsequent container load as a new batch without a potential common cause, like manufacturing defects? Testing every single batch for any possible harmful defects?
      - A_D_E_P_T 3y ago
        Every import, which could be multiple container loads. If there's a manufacturing defect, the manufacturer -- after losing a couple of batches or having them returned to sender, and having paid for multiple transit and testing costs -- should wise up. In any case, this would absolutely protect the US pharmaceutical supply chain without pushing unnecessary and excessively onerous requirements onto manufacturers. How foreign facilities manufacture drugs should not be the FDA's concern; drugs are chemical systems and chemicals are easily amenable to testing as things in themselves.
        robg 3y ago
        So instead of manufacturers bearing the cost of quality control during manufacturing you expect every single import to be tested for all potential contamination? How would that work exactly? And without documentation of quality assurance, how would any contamination be traced by the manufacturer?
        A_D_E_P_T 3y ago
        > How would that work? It's not difficult. There are known quantitative and qualitative testing methods for finished drug products, and these usually cost anywhere from a couple hundred to a few thousand dollars. In other words: It's typically very cheap. So say a company imports 1M doses, and say you're an FDA inspector. At the port of entry, you take a statistically valid sample from that batch of doses, and you subject them to those tests. (This could be at an FDA/Customs lab or a third party lab -- in any case, the importer pays.) If there's a problem, you either test additional samples, or dispose of the batch summarily with a note to the importer as to what you've found. Testing every import shipment, instead of stationing FDA inspectors overseas, would do more to improve the quality and availability of drugs, and more to reduce costs. As things stand right now, a lot of drug companies don't want anything to do with the USA simply because they don't want the FDA getting into their business, inspecting their facilities, etc. It is a great, and wholly unwarranted and unnecessary, burden. > how would any contamination be traced by the manufacturer? That's not the FDA's problem. A batch of drugs is a thing in itself. A metformin capsule is a metformin capsule regardless of who made it and how. But of course there would be import records and any halfway competent manufacturer would be able to tie a shipment to a production run.

by robg 3y ago

You don’t mention quality controls. What should FDA do if upon said random testing there are concerns? How can they and/or the manufacturer trace the causes without documentation?

A_D_E_P_T 3y ago

> What should FDA do if upon said random testing there are concerns? Destroy or return the entire batch, depending on the level of concern. > How can they and/or the manufacturer trace the causes without documentation? That shouldn't be the FDA's concern. The FDA's concern should begin and end with the quality of the actual drugs that are entering the US supply chain. The drugs are things in themselves and can be tested as such -- without regard to where they came from or exactly how they were made.

robg 3y ago
A random sample by definition isn’t the entire batch, so how would you define ‘batch’ without documentation? The FDA would force recall on the entire product entering the country? Until how many samples are cleared?
- A_D_E_P_T 3y ago
  Pretty simple. Most cheap generic drugs are imported by the containerload, so simply create an arbitrary "batch" from each instance of importation. If the manufacturer is decent and has its own batch number, then the label could read "Manufacturer batch: XXXX FDA Import of Record batch: YYYY." Drugs that are imported in more specialized ways -- e.g. by small-volume refrigerated air freight -- are, as a general rule, far more expensive and batches are correspondingly smaller. The above paradigm would still work, where each importation instance is, for the FDA's purposes, a batch. Testing fees, which shouldn't amount to more than a few thousand bucks per import, can be the responsibility of the importer -- so as to dissuade importers from receiving small batch after small batch.
  - robg 3y ago
    So you treat each subsequent container load as a new batch without a potential common cause, like manufacturing defects? Testing every single batch for any possible harmful defects?
    - A_D_E_P_T 3y ago
      Every import, which could be multiple container loads. If there's a manufacturing defect, the manufacturer -- after losing a couple of batches or having them returned to sender, and having paid for multiple transit and testing costs -- should wise up. In any case, this would absolutely protect the US pharmaceutical supply chain without pushing unnecessary and excessively onerous requirements onto manufacturers. How foreign facilities manufacture drugs should not be the FDA's concern; drugs are chemical systems and chemicals are easily amenable to testing as things in themselves.
      - robg 3y ago
        So instead of manufacturers bearing the cost of quality control during manufacturing you expect every single import to be tested for all potential contamination? How would that work exactly? And without documentation of quality assurance, how would any contamination be traced by the manufacturer?
        A_D_E_P_T 3y ago
        > How would that work? It's not difficult. There are known quantitative and qualitative testing methods for finished drug products, and these usually cost anywhere from a couple hundred to a few thousand dollars. In other words: It's typically very cheap. So say a company imports 1M doses, and say you're an FDA inspector. At the port of entry, you take a statistically valid sample from that batch of doses, and you subject them to those tests. (This could be at an FDA/Customs lab or a third party lab -- in any case, the importer pays.) If there's a problem, you either test additional samples, or dispose of the batch summarily with a note to the importer as to what you've found. Testing every import shipment, instead of stationing FDA inspectors overseas, would do more to improve the quality and availability of drugs, and more to reduce costs. As things stand right now, a lot of drug companies don't want anything to do with the USA simply because they don't want the FDA getting into their business, inspecting their facilities, etc. It is a great, and wholly unwarranted and unnecessary, burden. > how would any contamination be traced by the manufacturer? That's not the FDA's problem. A batch of drugs is a thing in itself. A metformin capsule is a metformin capsule regardless of who made it and how. But of course there would be import records and any halfway competent manufacturer would be able to tie a shipment to a production run.