Commissioner Scott Gottlieb has released a statement on the FDA’s approach to curbing opioid abuse.

Reducing the scope of the epidemic of opioid addiction is my highest immediate priority as Commissioner, and since joining the FDA two months ago, I’ve been working with my colleagues to capitalize on the good work that has already been done and expand those efforts in novel directions. I’ve asked my FDA colleagues to take a fresh look at some key features of the agency’s regulation of opioids, including provider education, benefit-risk assessment in the pre- and post-market setting, and steps we can take to reduce overall exposure to these drugs. As we continue these efforts, I was encouraged to see that many of NASEM’s recommendations for the FDA are in areas where we’ve already made new commitments.

Among these important new actions is our work to ensure drug approval and removal decisions are made within a benefit-risk framework that evaluates not only the outcomes of opioids when used as prescribed, but also the public health effects of the inappropriate use of these drugs. More on this important topic can be found in our recent article in the Journal of the American Medical Associationdisclaimer icon. We’ve already begun to put this policy to work. Last month, the agency requested the removal of an opioid product from the market based on concern that the product’s risks associated with its deliberate misuse outweigh its intended benefits when it was used as directed and lead to dangerous unintended consequences.

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