APS E-News | Advocacy Update Report | July 2018
FDA Commissioner Says Balance Access to Appropriate Treatment with Need to Stem Misuse and Abuse of Opioids
In a lengthy public statement issued by the Food and Drug Administration (FDA) on July 9, Commissioner Scott Gottlieb pledged: “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.”
Gottlieb also challenged physicians to be more selective in determining which patients should be prescribed opioids.
“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 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, careful, and tailored approaches to the treatment of their medical conditions.”
Gottlieb also placed significant blame on the flow of illicit opioids like fentanyl for fueling the opioids crisis and adding to the death toll.
“We have evidence that we’ll release soon showing that based on a measure of morphine equivalents, the flow of illicit opioids, particularly fentanyl, dwarfs the entire market for prescription drugs. These statistics suggest that more of the new addiction is going to rise out of the use of illicit drugs, and more of those who become addicted following a lawful prescription could more quickly migrate onto illegal formulations such as fentanyls. Given the magnitude of the current epidemic, we must act forcefully to confront these new turns in this crisis.”
Gottlieb stated that the FDA’s goal is to support more rational prescribing practices, as well as identify and encourage development of new treatment options that don’t have the addictive features of opioids.
“In this way, we’ll help ensure that we’re not unnecessarily putting patients as risk of addiction by overprescribing opioids, while also maintaining appropriate access to care for patients with serious pain."
