The FDA is asking generic drug makers to work together on drug formulations that discourage or make difficult abusive behaviors including crushing the pills to snort or inject them. Photo by Shutterstock
BETHESDA, D.C., March 24 (UPI) -- The FDA has asked pharmaceutical companies to work together on abuse-deterrent generic versions of their opioid-based painkillers as part of the agency's expanded efforts to reduce dependence, addiction and death as a result of improper use of the drugs.
While no deterrent can fully stop misuse of opioid painkillers, efforts to make make them more difficult to crush or inject have been shown to reduce abuse, FDA officials said.
The FDA has stepped up its efforts in recent weeks to help stem epidemic of opioid abuse that has grown sharply in the last decade, announcing a multi-step plan of action in February. The agency earlier this week announced new requirements for drug labels to clearly state dangers.
The Centers for Disease Control and Prevention also released new guidelines earlier this month aimed at helping doctors prescribe the drugs more carefully.
"Collaboration is critical in fostering innovation in the field of abuse deterrence," Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA, said in a press release. "It is essential that a generic product is no less abuse-deterrent than the brand name product. We look forward to actively engaging in discussions to help inform our thinking about the evaluation of abuse-deterrent technologies."
The FDA said it has not been presented a drug for approval aimed at preventing abuse of opioid while taking whole pills, however the agency is asking the industry to continue approving methods to prevent crushing pills to snort or inject.
The agency also recognizes more research is needed on abuse prevention technologies, and called for more rigorous studies showing their efficacy.
"We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse," said Dr. Robert Califf, commissioner of the FDA. "But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy."