In March 2016, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management. We greatly appreciate all the work done by NASEM over the past year to produce the comprehensive report released today, which includes recommendations for the FDA and others on this important issue.
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 Association. 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.
One of the areas in which we can have the greatest impact is in reducing the rate of new addictions by helping to make sure that only appropriately indicated patients are prescribed opioids, and that the prescriptions are for durations and doses that properly match the clinical reason for which the drug is being prescribed in the first place. To do so, we must make sure that providers are properly informed about suitable prescribing and the risks and benefits associated with opioid drugs. Earlier this week, I announced that the FDA intends to update and modify the existing Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting opioid analgesics, and for the first time, include immediate-release opioid analgesic products in the modified REMS program. The modified REMS will include revisions to the existing FDA Blueprint for prescriber education, which describes the content that must be covered in an educational program for it to be considered REMS-compliant. We will also ask, for the first time, that this training be made available to non-physician providers, including nurses and pharmacists. Under the modified REMS, the training will continue to be provided by accredited continuing education providers, but we have proposed that the training include broader information on pain management and enhanced information about the safe use of opioid analgesics, basic elements of addiction medicine, and opioid use disorders. As part of our Opioid Policy Steering Committee, we will continue to evaluate what additional steps we need to take to make sure providers are properly informed about the risks and benefits of these drugs. As part of these efforts, we will consider the appropriateness of mandatory education, and how we’d operationalize such a requirement.
Another important area in which we are focusing our efforts is in securing the critical data needed to better understand the impact of opioid medications. Just this week, we gathered independent experts for a scientific workshop to discuss both the existing science and what else is needed to properly assess the impact of opioid formulations with abuse-deterrent properties on misuse, abuse, addiction, overdose, and death. The FDA strongly supports a transition from the current market dominated by conventional opioids to one in which the majority of opioids having meaningful abuse-deterrent properties. At the same time, the agency is encouraging the development of new treatment options for patients in pain, especially treatments that are not addictive. We’re also continuously re-evaluating the safety of approved opioid products based on both post-market data the FDA has required from sponsors and additional sources of information as part of our safety surveillance. We will continue to consider what additional information is needed to ensure we have the right data to make important, science-based decisions.
These are just some of the important efforts we have underway. But to make a meaningful impact, this epidemic must be addressed as a public health emergency, and requires an all-of-the-above approach. As underscored in the NASEM report, the scope of this epidemic is so large, it’s going to require a coordinated effort that includes federal, state, and local partners to properly address its continued destruction of individual lives and families. This complex public health emergency demands the attention and involvement of all parties – including the FDA and other government agencies, health care providers, the medical products industry, policy makers, patients and their families. We’re committed to doing our part and will continue to use our regulatory authority to reduce the scope of this immense public health crisis.
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