The next to the last sentence was a question (though it had a period), so let me answer it. The FDA is part of the executive branch of the government and as we should know from civics that means the balance of power suggests either judicial or legislative oversight can be applied. Now, as we are all paying attention to what is happening in the external environment (a requirement for a strategic manager or investor) we can clearly see litigation in Kentucky, Illinois and the political maelstrom in Massachusetts all related to opioid abuse (and Purdue is in the midst of it, but they declined a meeting with the FDA). While I am not sure if it is the "perfect storm" as some have indicated, it is very much a matter of public concern that can and will affect the FDA. Any doubts of that and I can point to the issues with Vioxx that created both a judicial and legislative response (and huge financial awards to consumers). The opioid pain med market is too big and too important to be ignored by external forces (again, considering the size of the aging baby boomers, the increase in surgical procedures, and the migration of the use of other pain meds to opioids). In fact, if the pharma industry does not solve their problem of product abuse, assisted by the FDA, then it will be addressed either judicially or legislatively. This is the US and that is how it is done.
For Elite, if they have the goods, they are in-play; as would be any other firm seeking to compete with ADFs. What they will all be required to do is dance the steps set out by the FDA, but recognizing there are eyes on it all. So, if one is required to complete a specific BE, HAL or P-3 trial, it would not be unreasonable for others to as well. Otherwise, the very concern you pointed to, larger and more powerful firms may well wield too much influence. Companies ask for a level playing field in the US and that much we should expect to see.
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