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Policy also has to be flexible when it comes to things with as many complexities as medication. Coming up with a universal standard for approval is extremely di

Policy also has to be flexible when it comes to things with as many complexities as medication. Coming up with a universal standard for approval is extremely difficult. There can be issues both if it's too rigid or too lax. The role of policy in most cases such as this is supposed to be a guide, not a strict pass or fail for every possible criteria. Discretion from the regulators is needed to accommodate for cases that don't fit neatly into existing policies. As a comparison, look at how nearly all of the big social media platforms all struggle with policy interpretation and enforcement around topics such as misinformation or hate speech.

zepto 5y ago
> The role of policy in most cases such as this is supposed to be a guide Sure, so we should be able to see what guidance was followed. > Discretion from the regulators is needed to accommodate for cases that don't fit neatly into existing policies. Discretion doesn’t mean policy can be ignored. Discretion would be part of the policy, and we should be able to see what discretion was used to come to these decisions.
- kongolongo 5y ago
  I didn't say discretion means policy can be ignored, it's part of the interpretation of policy. Whether or not a policy is applicable for specific circumstances is part of discretion. It explains why policy is not universally applied and appears inconsistent. Nothing about one drug being denied approval despite having more successful trials than another drug alone demonstrates that policy was ignored or that it wasn't considered.
  - zepto 5y ago
    > Nothing about one drug being denied approval despite having more successful trials than another drug alone demonstrates that policy was ignored or that it wasn't considered. No, it doesn’t ‘demonstrate’ it, but it certainly makes it into a candidate explanation that can’t be dismissed.

zepto 5y ago

> The role of policy in most cases such as this is supposed to be a guide Sure, so we should be able to see what guidance was followed. > Discretion from the regulators is needed to accommodate for cases that don't fit neatly into existing policies. Discretion doesn’t mean policy can be ignored. Discretion would be part of the policy, and we should be able to see what discretion was used to come to these decisions.

kongolongo 5y ago
I didn't say discretion means policy can be ignored, it's part of the interpretation of policy. Whether or not a policy is applicable for specific circumstances is part of discretion. It explains why policy is not universally applied and appears inconsistent. Nothing about one drug being denied approval despite having more successful trials than another drug alone demonstrates that policy was ignored or that it wasn't considered.
- zepto 5y ago
  > Nothing about one drug being denied approval despite having more successful trials than another drug alone demonstrates that policy was ignored or that it wasn't considered. No, it doesn’t ‘demonstrate’ it, but it certainly makes it into a candidate explanation that can’t be dismissed.