Gottlieb’s ‘Highest Initial Priority’ is Opioid Crisis

Writing in his first FDA Voice blog post as commissioner, Scott Gottlieb says his “highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction.” He writes that he e-mailed his agency colleagues to tell them of the first steps he plans to take to achieve his goal.

“I believe that it is within the scope of FDA’s regulatory tools, and our societal obligations, to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients,” Gottlieb says. “Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction. Moreover, as FDA does in other contexts in our regulatory portfolio, we need to consider the broader public health implications of opioid use. We need to consider both the individual and the societal consequences.”

The post says that while FDA has done a lot of good work on this issue to date, Gottlieb has asked the staff to look at “what additional forceful steps we might take.” As a first step, he says, he is creating an Opioid Policy Steering Committee to bring together some of the agency’s most senior career leaders to explore and develop additional tools or strategies FDA can use to confront the crisis. Questions he has asked the committee to consider are: 

•          Are there circumstances under which FDA should require some form of mandatory education for healthcare professionals so they are properly informed about appropriate prescribing recommendations, understand how to identify the risks of abuse in individual patients, and know how to get addicted patients into treatment?
•          Should FDA take additional steps under its risk management authority to make sure that the number of opioid doses that an individual patient can be prescribed is more closely tailored to the medical indication?
•          Is FDA using the proper policy framework to adequately consider the risk of abuse and misuse as part of the drug review process for the approval of these medicines?

“Working together,” Gottlieb concludes, “we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider. I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding these efforts in novel directions. I will keep you updated on our work as we continue to confront this epidemic.”