4 ms·

You expect consistency from the IRS, because that domain is easy to fully articulate and constrain inside policy. You don't expect it in the FDA because the tr

You expect consistency from the IRS, because that domain is easy to fully articulate and constrain inside policy. You don't expect it in the FDA because the trade-offs between safety, efficacy, urgency, clinical/statistical significance, and other dimensions are going to be rather specific to each silo of expertise/each product, and rather difficult to fully prescribe and encode a priori. So out of necessity, some amount of discretion and autonomy are going to be provided to each group of specialists, and you are bound to get inconsistency.

zepto 5y ago
That doesn’t mean there can’t be a policy. Drug safety is based on science, after all.
- deleted 5y ago
  [deleted]
- fighterpilot 5y ago
  There can be policy, it just can't be as prescriptive as you're asking for. Consider the review process for paper submissions to scientific journals. You can't prescribe an exhaustive checklist to Nature reviewers and ask them to mechanically follow it. You need to give the reviewers some autonomy. And with that autonomy will come inconsistency.
  - zepto 5y ago
    > can't be as prescriptive as you're asking for. What do you think I am asking for?
    - fighterpilot 5y ago
      It sounds like you want a policy that sets a standard and for discretion to be explicitly mentioned in the policy, and that if one drug that's less effective is approved over another then policy violation is a candidate explanation. Which is all probably already the case. The standard is probably rather loosely defined out of necessity, due to the reasons I suggested previously, and it follows that "inconsistency" will necessarily come from the part of the policy that allows for discretion. It doesn't follow that this inconsistency is bad, it could mean that in one domain or one product, certain considerations should get more weight. That's the point of the discretion, to allow the specialists to upweight and downweight those considerations that matter more or less for a given product. So my point is that some inconsistency is to be expected, a subset of it is good, and no inconsistency would actually be a cause for concern. What are we disagreeing about?
      - zepto 5y ago
        > Which is all probably already the case. Remember - my comments about policy were a response to this: > It probably makes more sense if we view the FDA not as a monolith but a collection of lots of individuals, some of which don't communicate or work together directly. The comment I was replying to implied that the discrepancy was simply due to disparate groups of people not in communication. Your view now seems to be the opposite - it is that they are in communication, and have a policy but that subject matter is complex and will legitimately generate the range of responses we see.
        fighterpilot 5y ago
        They're almost certainly not in communication but share an overarching policy which is intentionally vague enough to allow for some autonomy and flexibility. Hence expected inconsistency.

zepto 5y ago

That doesn’t mean there can’t be a policy. Drug safety is based on science, after all.

deleted 5y ago
[deleted]
fighterpilot 5y ago
There can be policy, it just can't be as prescriptive as you're asking for. Consider the review process for paper submissions to scientific journals. You can't prescribe an exhaustive checklist to Nature reviewers and ask them to mechanically follow it. You need to give the reviewers some autonomy. And with that autonomy will come inconsistency.
- zepto 5y ago
  > can't be as prescriptive as you're asking for. What do you think I am asking for?
  - fighterpilot 5y ago
    It sounds like you want a policy that sets a standard and for discretion to be explicitly mentioned in the policy, and that if one drug that's less effective is approved over another then policy violation is a candidate explanation. Which is all probably already the case. The standard is probably rather loosely defined out of necessity, due to the reasons I suggested previously, and it follows that "inconsistency" will necessarily come from the part of the policy that allows for discretion. It doesn't follow that this inconsistency is bad, it could mean that in one domain or one product, certain considerations should get more weight. That's the point of the discretion, to allow the specialists to upweight and downweight those considerations that matter more or less for a given product. So my point is that some inconsistency is to be expected, a subset of it is good, and no inconsistency would actually be a cause for concern. What are we disagreeing about?
    - zepto 5y ago
      > Which is all probably already the case. Remember - my comments about policy were a response to this: > It probably makes more sense if we view the FDA not as a monolith but a collection of lots of individuals, some of which don't communicate or work together directly. The comment I was replying to implied that the discrepancy was simply due to disparate groups of people not in communication. Your view now seems to be the opposite - it is that they are in communication, and have a policy but that subject matter is complex and will legitimately generate the range of responses we see.
      - fighterpilot 5y ago
        They're almost certainly not in communication but share an overarching policy which is intentionally vague enough to allow for some autonomy and flexibility. Hence expected inconsistency.