The Food and Drug Administration is making moves to spur development of generic and cheaper opioids that are difficult to abuse.
The agency released new regulatory guidance on Tuesday aimed at helping drugmakers develop these products much easier. While there are already some abuse-deterrent painkillers on the market, they are only brand name drugs that are more expensive than a generic.
An abuse-deterrent opioid can’t be injected or chewed, common routes of abuse by addicts. It also makes it difficult to crush a tablet to snort it. Federal data shows that 91 Americans die every day from opioid overdoses.
So far, the FDA has approved 10 abuse-deterrent opioids. However, their uptake has been slow among doctors, according to FDA Commissioner Scott Gottlieb.
“The reason for their more limited use is multifold,” he said in a statement. “We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions.”
But Gottlieb added price is another “significant barrier.”
A brand name drug is much more expensive than a generic version. There are already numerous generic opioids on the market without the abuse-deterrent features, so there is already a cheaper alternative for doctors to pursue.
The guidance hopes to help drug makers by outlining how to easily develop the products, including recommendations about the types of studies companies need to conduct to win FDA approval.
Gottlieb added the FDA is taking additional steps to help makers of generic abuse-deterrent opioids. These include meeting with generic makers very early in the regulatory process to avoid any potential hiccups.
