Scott Gottlieb, MD, US Food and Drug Administration (FDA) Commissioner, has outlined the FDA's plans to tackle the nation's opioid abuse epidemic. Speaking to the House Committee on Energy and Commerce Hearing, he described opioid addiction as the "biggest crisis facing public health officials".
Opioids include illicit drugs such as heroin, but also prescription pain relieving medication such as oxycodone, hydrocodone, codeine, morphine, and fentanyl. More than 90 Americans die every day as a result of overdosing on opioids, according to figures from the Centers for Disease Control and Prevention. Furthermore, the Center for Behavioral Health Statistics and Quality 2015 National Survey on Drug Use and Health found that of the 20.5 million adult Americans over 12 years of age with a substance use disorder in 2015, two million had a substance use disorder involving opioids.
In his latest statement on the issue, Gottlieb announced three new steps. First, the FDA will issue new guidance to drug developers in a bid to increase and promote the development of addiction treatments. Second, it will promote the use of addiction therapies already approved by the FDA. The third step involves joining efforts to reduce the stigma attached to medications used for addiction treatment and taking action improve understanding about these drugs.
"Someone who requires long-term treatment for opioid addiction with medications - including those that cause a physical dependence - is not addicted to those medications," he asserted. Among the medicines currently used in the treatment of opioid addiction are methadone and Suboxone (buprenorphine hydrochloride, naloxone).
The FDA's Commissioner outlined a number of ways in which the regulatory body is working to deal with the opioid epidemic. These included updating and extending risk management plans and the risk-benefit framework used to evaluate opioids, which could lead to recommendations that some products be withdrawn from the market. The FDA has already taken steps to remove certain opioids from the market and to approve drugs less prone to abuse. For example, in June 2017, it requested Endo Pharmaceuticals remove Opana ER (oxymorphone hydrochloride) from the market after concluding the benefits of the drug no longer outweighs the risks.
Gottlieb also announced the FDA will be "doubling our efforts to promote the development of new, less addictive pain remedies; as well as opioids that are harder to manipulate and abuse". Some opioid formulations, for example Hysingla ER (hydrocodone bitartrate), have properties to discourage abuse by making them more difficult to crush for snorting or dissolve for injection. Other opioid medications, such as Embeda (morphine sulphate and naltrexone hydrochloride), combine the opioid analgesic with a drug to block the opioid high.
