FDA Commissioner’s Statement on Prescription Opioid Abuse

For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other. Tragically, the most recent data shows that more than 16,000 lives are lost each year due to opioid-related overdoses. In fact, drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic. The FDA has taken steps to address this but more work remains to be done. Combatting the serious public health problem of misuse, abuse, addiction and overdose from opioid analgesics is a high priority. Since 2001 the FDA has taken a number of actions designed to help address prescription opioid abuse and to encourage the development of new drug treatments for pain. These actions include: • Revising the labeling for opioid medications to foster their safe and appropriate use, including recent changes to the indications and safety warnings of extended-release and long-acting opioids. • Requiring that manufacturers conduct studies of the safety of long-term use of prescription opioids. • Improving appropriate prescribing by physicians and use by patients through educational materials required as a part of a risk mitigation strategy for extended-release and long-acting opioids. • Using the agency’s expedited review programs to advance development of new non-opioid medications to treat pain with the goal of bringing new non- or less-abusable products to market. • Recommending that hydrocodone-containing combination products have additional restrictions on their use by rescheduling them from Schedule III to Schedule II. • Strengthening surveillance efforts to actively monitor the changing nature of prescription opioid abuse and to identify emerging issues. • And, importantly, encouraging the development of medications to treat opioid abuse, such as buprenorphine for use in medication-assisted treatment, and to reverse opioid overdoses, such as naloxone. Today’s FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety. Reflecting the FDA’s commitment to encouraging important new therapies, the FDA’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks. This product is the first auto-injector designed to rapidly reverse the overdose of either prescription or illicit opioids. While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives.