FDA Abuse Deterrent Opioids Hearing

FDAThe management of pain in the United States is a huge industry; the rate of those suffering from chronic pain is at an all time high. While the use of powerful opioids like oxycodone to treat pain is effective, researchers and health professionals all agree that the rampant prescribing of opioids attracts abusers. The federal government continues to look at various ways to curb the prescription drug epidemic, with the latest effort being mandates for abuse deterrent medications; however, there are a number of people who argue that abuse deterrent drugs are not the answer.

The Food and Drug Administration’s (FDA) goal is to incentivize the creation of abuse-deterrent opioids and to discuss the fate of non-abuse deterrent opioids. An FDA hearing regarding abuse-deterrent opioids showed that there are a number of disagreements among experts, MedPageToday reports.

Currently, there are only three medications that have been granted abuse-deterrent labeling consistent with the FDA’s Abuse-Deterrent Opioids – Evaluation and Labeling guidelines: A reformulated Oxycontin, the combination product Targiniq (oxycodone with naloxone), and the combination product Embeda (morphine with naltrexone).

The FDA lacks a clear set of rules for drug companies that want to produce a generic opioid that competes with an abuse-deterrent brand-name opioid, the article notes. The reason for this is the many ways opioids can be abused; dissolving the drugs for injection, crushing for snorting, or smoking. Drug companies wanting to produce a generic opioid to compete with an abuse deterrent drug will have to go before the FDA on a case-by-case basis.

At the hearings, a number of speakers raised concerns about limiting use of opioids lacking abuse-deterrent properties. It was pointed out that removing non-abuse deterrent formulations would lead to shortages or increase prices, resulting in patients being unable to afford their medications.

The Department of Veterans Affairs’ C. Bernie Good noted that the VA primarily uses generic drugs, spending almost $89.4 million annually. He called for more studies “to know that we are benefiting society, and it’s not just decreasing the abuse in terms of crushing or snorting, but that actually at the end of the day, we have fewer deaths, fewer unintentional overdoses, et cetera, and that there aren’t unintended consequences like people going to heroin.”