FDA’s Gottlieb Wants More Rigorous Standards for Prescribing Opiates

Food and Drug Administration Commissioner Scott Gottlieb, MD says his agency needs to do more to help stem the opioid-addiction epidemic in the United Sates. For starters, he wants the FDA to impose stricter guidelines for prescribing immediate-release opioid drugs. The first step will be for the agency to expand training for physicians, nurses, and other providers who administer immediate-release opioids. While there is already training available, the FDA says it will now broaden information it provides about nondrug, not just nonopioid, approaches to pain control. Gottlieb promises the agency will also conduct a study of doctors’ understanding of abuse-deterrent features of various pain drugs. The FDA is ratcheting up its efforts to help healthcare professionals fight abuse of drugs that can be beneficial—even necessary—when used properly as the public becomes more aware of the dangers and prevalence of opioid abuse. The announcement of the FDA’s plan came just days before a major crackdown by the Department of Justice and the Department of Health and Human Services on medical professionals who have engaged in Medicare fraud—including some who were charged with distributing opioids and other prescription drugs illegally.