The opioid epidemic continues to take an emotional, physical and financial toll on Americans. The U.S. Food and Drug Administration is committed to taking every possible step to address the many facets of this complex public health crisis.
While we work to ensure appropriate and rational prescribing of opioids, we won’t lose sight of the needs of Americans living with serious chronic pain or coping with pain at the end of life. They too face significant challenges.
So, as we consider new policy steps to address the opioid addiction crisis, the FDA remains focused on striking the right balance between reducing the rate of new addiction by decreasing exposure to opioids and rationalizing prescribing, while still enabling appropriate access to those patients who have legitimate medical need for these medicines.
Today, the FDA is holding a Patient-Focused Drug Development meeting to gather additional viewpoints directly from adult and pediatric patients living with chronic pain. We’ve asked them to share their perspectives on the impact of chronic pain on their everyday lives; treatment approaches using medications such as opioids, acetaminophen, non-steroidal anti-inflammatory drugs, antidepressants, as well as other medications; and non-pharmacologic interventions or therapies, including medical devices that can deliver local analgesia and reduce or obviate the need for systemic therapy.
We want to better understand the challenges or barriers patients face accessing various treatments for pain. We’re hopeful that this meeting will provide valuable insights to inform our opioid policies and advance our efforts to develop better therapies.
Unfortunately, the fact remains that there are still too many prescriptions being written for opioids, and too many prescriptions written for long durations of use that aren’t appropriate for the medical need for which the opioid is being prescribed. This presents a difficult challenge both for the FDA and for providers. We don’t want to perpetuate practices that led to the misuse of these drugs, and the addiction crisis. At the same time, we don’t want to act in ways that are poorly targeted, and end up disadvantaging legitimate patients.
In most circumstances, opioids should only be used for the treatment of acute pain and prescribed for short durations of time. However, the FDA is aware that there are certain circumstances ‒ such as in the treatment of metastatic cancer pain and the episodic treatment of migraine pain ‒ where the drugs are administered over longer periods. In select patients and for certain medical conditions, opioids may be the only drugs that provide relief from devastating pain. We’ve heard from some of these patients, and listened carefully to their concerns about having continued access to necessary pain medication. We’ve heard their fear of being stigmatized as a person with addiction, and the challenges they face in finding health care professionals willing to work with patients with chronic pain. Tragically, we know that for some patients, loss of quality of life due to crushing pain has resulted in increased thoughts of or actual suicide. This is unacceptable. Reflecting this, even as we seek to curb overprescribing of opioids, we also must make sure that patients with a true medical need for these drugs can access these therapies.
At the FDA, we’re taking a number of new steps to address the need to aggressively confront the epidemic of addiction, while advancing policies to help make sure that patients with pain have access to appropriate, evidence-based care.
Balancing the need to maintain access with the mandate to aggressively confront the addiction crisis starts with good medical management. All patients in pain should benefit from the skillful and appropriate care of their pain. It’s also critical that we take this same aggressive approach to changing the culture of medicine around treating pain. The roots of this crisis are embedded in the practice of medicine, and prescribing practices that were at times too cavalier. A generation of providers dispensed these medicines too liberally, and were slow to address the signs of misuse and addiction. At the same time, we know that some manufacturers inappropriately promoted these drugs for unapproved uses. Patients in pain deserve thoughtful, carefu...
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