By: Douglas C. Throckmorton, M.D.
We hear tragic stories in the news about prescription medications ending up in the wrong hands and accidental deaths from overdoses. It’s become an epidemic. Today, FDA Commissioner Hamburg participated in a briefing with the White House Office of National Drug Control Policy to address startling new statistics about the abuse of prescription drugs, especially painkillers. While society as a whole has a role to play – the majority of new or occasional nonmedical users of pain relievers obtained the drug from family or friends for free or took them without asking – I’d like to tell you what FDA is doing to address this public health crisis.
First of all, FDA is strengthening educational efforts in the use of opioids medicines. Through our work on the Opioid Risk Evaluation and Mitigation Strategy (REMS), FDA has created an outline of the information prescribers and patients need to know to balance the benefits of these drugs against the risks of serious outcomes including addiction, unintentional overdose, and death. Once finalized, this outline will be made available for use by educational providers to assist efforts to educate prescribers.
FDA is also strengthening the tools available to improve the use of opioid medicines. As a part of the President’s Prescription Drug Abuse Prevention Plan, FDA has convened a panel of outside experts to create a model Patient-Provider Agreement (PPA) to help guide the ongoing use of these powerful medicines while reducing the development of addiction and their misuse. In addition, FDA is supporting the Prescription Drug Monitoring Program Center of Excellence at Brandeis University. This program is working to improve prescriber utilization of state Prescription Drug Monitoring Programs (PDMPs) and also to examine the impact of strategies to reduce misuse and abuse of opioid medicines.
FDA is strengthening the science behind the use and misuse of opioid medicines. Last week FDA worked with National Institute on Drug Abuse (NIDA) and the Centers for Disease Prevention and Control (CDC) to convene an important public meeting on the use of naloxone as a treatment for deadly overdoses. The goal of the meeting was to find ways to reduce the thousands of unnecessary overdose deaths occurring in the US every year, including deaths due to prescription opioids. FDA has also announced plans to hold a two-day meeting to review the scientific data on the use of opioid drugs for the treatment of chronic pain.
Additionally, FDA is coordinating with Federal partners in programs like the Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION). This partnership has been designed to streamline the discovery and development process for new analgesic medications and to more generally accelerate the development of pain treatments with improved efficacy and safety
FDA has been working to strengthen the science for assessing the abuse potential of new drugs. In October, 2011, FDA participated in a public workshop to discuss the science of abuse liability assessment. The public workshop was co-sponsored by FDA, the National Institute on Drug Abuse (NIDA) and the College on Problems of Drug Dependence (CPDD) at the Temple University School of Medicine. Feedback from this workshop has been instrumental in determining FDA guidance and necessary pathways for assessing the abuse potential for new drugs.
And, FDA has been working to speed the development of new medicine with reduced potential for abuse. FDA intends to issue an industry guidance on the development of new formulations of opioid medicines that are harder to abuse and misuse, a guidance that will also outline how the FDA will assess such formulations.
Finally, we know that one part of the solution to preventing misuse and abuse of medicines is to dispose of them promptly once they’re no longer used. On Saturday April 28, the Drug Enforcement Agency has scheduled National Prescription Drug Take-Back Day at sites across the country, to help dispose of all types of unneeded medicines. We recently communicated about the importance of this activity and are proud to support this effort through a site at FDA’s headquarters facility at White Oak, in the Maryland suburbs of Washington, D.C. Additionally, for a small number of potent medicines, mostly pain medicines, FDA recommends flushing them down the toilet or sink, to keep them away from children and pets. You will find a list of these medicines on FDA’s website.
Science and innovation have allowed us to develop sophisticated prescription medications for public health and wellness needs. When we find out they are being diverted to inappropriate uses or not disposed of properly we must do all we can to solve the problem. FDA is committed to making a difference in this epidemic, and we will actively continue our work with other Federal agencies to implement the Administration’s goal to reduce prescription drug misuse, abuse and addiction.
Douglas C. Throckmorton, M.D., is FDA’s Deputy Director for Regulatory Programs in the Center for Drug Evaluation and Research.