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> 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.

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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.

> 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.

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