FDA spokesman Michael Felberbaum provided Marketplace with this statement in response to The Uncertain Hour’s investigation into the agency and Purdue Pharma, the maker of OxyContin.
The goal when developing a drug label is to include the necessary information about a drug’s safety and efficacy so that trained physicians can use this information and their medical expertise to make informed decisions for their patients. The FDA continues to evaluate labels for opioids, including OxyContin, to ensure they contain the essential information about the use of these drugs and the risks of abuse, addiction and overdose, and will revise labeling as necessary to improve proper prescribing and treatment. The agency is also focused on making certain that health care providers are properly informed about appropriate prescribing recommendations, understand how to identify the risk of abuse in individual patients, and know how to get addicted patients into treatment.
The public health crisis of opioid addiction and overdose is a tragic situation that has evolved over a number of years and has been the result of a confluence of factors. However, the agency is focused on making sure to learn from the lessons of the past to inform the actions we take moving forward, including a shift in the agency’s policy efforts to consider how opioids are used not just by appropriate patients but also by people who are using them for non-medical reasons and identifying creative solutions within the FDA’s authority to address the epidemic.
In particular, the FDA is focused on several priorities to confront the staggering human and economic toll created by opioid abuse and addiction, including: decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies; and improving enforcement and assessing benefit-risk. The FDA will also continue looking at how drugs that are already on the market are used, in both medical settings and also illicit ones, and take action where needed.
In order to properly address this crisis, we know it requires an all-of-the-above approach that will require each of us to work together ‒ the FDA and other government agencies, health care providers, the medical products industry, policy makers, patients and their families. At the FDA, we remain steadfast in using all facets of our regulatory authority to change the trajectory of this epidemic.
See chronological information about FDA activities and significant events related to opioids, including abuse and misuse here.