Gottlieb announces FDA steps to address opioid epidemic, nicotine addiction
November 5, 2017 | By Michelle Amber | email@example.com
Commissioner Scott Gottlieb announced that FDA is evaluating oxymorphone, an active ingredient in opiods, for qualities that make it more likely to be abused than other drugs. The study is a prelude to considering regulatory action to limit exposure to it, he said at a Headliners Luncheon event Nov. 3.
Gottlieb said the question is whether oxymorphone has qualities that make it “more likely to be abused than other Schedule II opioids, including through illicit routes of administration such as snorting and injection.” He did not indicate when the study might be finished.
The study is just one part of the agency’s efforts to address the opioid epidemic, Gottlieb said, adding that FDA is reconsidering how it addresses “risk and benefit to make sure we’re taking appropriate measure of the risk associated with misuse and abuse of opioid drugs” during its pre- and post-market reviews.
Gottlieb noted that earlier this year FDA requested Endo Pharmaceuticals to withdraw its reformulated Opana ER from the market, as a result of a risk analysis associated with the drug’s “illicit” use. He said injection of the drug was leading to outbreaks of Hepatitis C and HIV. When asked if other companies would be asked to withdraw any opioids, he declined to comment on intentions with respect to any other specific drug.
Stating that many people who become addicted to opioids have their first exposure through a lawful prescription, Gottlieb said science-based evidence shows the key to reducing new addiction is to reduce exposure to opioids in the clinical setting. He added that the agency recently released a Federal Register notice to begin to “evaluate and perhaps implement, steps to reduce exposure to opioids through our influence on prescribers.” He said FDA is evaluating requirements for doctor education, package regulation and clinical guidelines for administering doses.
In addition to the opioid epidemic, Gottlieb said FDA is putting nicotine “at the center” of its regulatory strategy, adding his goal is to issue a notice of proposed rulemaking on the regulation of nicotine by the end of the year.
Gottlieb said the agency is taking steps to “render combustible cigarettes minimally or non-addictive,” which could prevent future generations of children becoming addicted to cigarettes.
“At the same time, we’re putting through an appropriate series of regulatory gates, new technology that’s emerging that could deliver nicotine to those adults who still want or need satisfying levels of this drug, but could enable them to get that nicotine in a way that may pose far less risk than smoking combustible cigarettes,” Gottlieb said.
The FDA commissioner announced that once the rules are promulgated he plans to have “listening sessions” with stakeholders including public health groups, trade associations and some large companies.