The FDA is considering higher standards for approval of new drugs, but these standards would be limited to opioids only because this therapeutic category is “unique,” according to Commissioner Gottlieb. The FDA may start to consider whether a new opioid drug application has any benefits over what is already available on the market, rather than just whether it is safe and effective. The FDA may require a new opioid drug to have some distinct, new value in comparison to drugs already approved.

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