Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Office of National Drug Control Policy Announcement
of the Prescription Drug Abuse Action Plan
April 19, 2011
Thank you Dr. Koh - and Director Kerlikowse for your kind introduction. And a special thank you to all of our colleagues and partners here today for your important work and for your months of collaboration on the national Prescription Drug Abuse Action Plan. I'm pleased to be here to show FDA’s support for the Administration’s initiative and to share our new public health efforts in this arena.
This morning, I’d like to speak to you as a physician and public health professional about the serious problem of misuse, abuse, illegal diversion, and inappropriate prescribing of opioid analgesics - and to outline an important action FDA is taking today to enhance appropriate pain management and promote safe use of these potentially addictive and dangerous products.
This action - which will support and act in concert with the Administration’s new Plan - is part of a new safety measure called a “Risk Evaluation and Mitigation Strategy” or REMS, which will apply to all long-acting and extended-release opioid products.
As you may know, opioids are a necessary part of pain management for certain patients but can bring serious risks when used improperly. For years, FDA, as well as drug manufacturers and others, have taken steps to prevent these tragedies through additional warnings in product labeling, educational efforts, conducting special projects and collaborations, and issuing direct communications to both prescribers and patients. But despite these efforts, the rates of misuse and abuse - and of accidental overdose - are still on the rise.
Now, we face an ongoing challenge and a dual responsibility. We must ensure that patients get what they need while preventing misuse and abuse from damaging the health and well being of individuals, families, and communities.
And that’s where our REMS program comes in. We will require companies to develop risk management plans to manage serious risks - and address the unique risk-benefit profile of this class of drugs. Companies will be required to develop educational materials for both prescribers and patients.
Our focus, above all, is to ensure that physicians have the knowledge and training to deliver effective pain management and care¬ - and that patients understand the risks of opioid products. And we will do this through two key features of the program: 1) medication guides to help patients understand the benefits and risks, and 2) new tools for prescriber training and patient education.
We believe that rigorous education for individual prescribers is critical, supporting appropriate use and reducing prescription drug diversion and abuse. FDA strongly supports the Administration’s call for mandatory prescriber education for opioids, which would require an amendment to Federal law.
At its core, this program is about action. So today I’d like to announce that FDA has sent letters to drug sponsors who market long-acting and extended-release prescription opioid analgesics - hydromorphone, oxycodone, morphine, oxymorphone, methadone and transdermal fentanyl. The letters lay out requirements and direct the drug sponsors to develop and submit REMS for these products - through a single, shared system for all members of this drug class.
FDA will approve all materials before they can be implemented, and we expect that all training will be conducted by accredited education providers. We are serious about holding sponsors accountable for results, and we will conduct periodic assessments to ensure that our program is indeed effective at reducing the tragic consequences of opioid misuse and abuse and improving public health.
I’d like to note that FDA received valuable input from a variety of industry leaders, health professionals, patients, and other stakeholders as we designed this program. I’d like to thank all those who contributed - as well as those of you who will continue to do so as we proceed with implementation.
This is, after all, a problem that touches all of us, in both our professional and our personal lives. And I look forward to continuing our work together as we build a safer and healthier America.