FDA Wants Abuse-Deterrent Generic Painkillers
One more step to combat the epidemic of potent painkiller abuse
By Steven Reinberg
THURSDAY, March 24, 2016 (HealthDay News) -- Continuing their push to combat the nation's epidemic of prescription painkiller abuse, U.S. officials on Thursday urged generic drug makers to take steps to redesign potent drugs such as hydrocodone and oxycodone to make them harder to abuse.
U.S. Food and Drug Administration officials said they were encouraging the generic drug industry to develop pain medicines with "abuse-deterrent properties." For instance, this would make it harder to crush a tablet to snort the contents or dissolve a capsule to inject its ingredients.
"By issuing the draft guidance, the FDA is helping to ensure that generic abuse-deterrent opioids are no less abuse deterrent than their brand-name counterparts," FDA Commissioner Dr. Robert Califf said during a morning press briefing.
"We hope that the availability of less costly generic products with abuse-deterrent properties has the potential to accelerate the shift away from the older products that do not include abuse-deterrent properties," he said.
The FDA is also requiring makers of brand-name narcotic painkillers with approved abuse-deterrent labeling to conduct long-term studies to see how effective the formulas are in reducing abuse in the real world.
The agency said it realizes that these formulas aren't foolproof and more research is needed.
But, given the lower cost of generic drugs, encouraging access to such drugs with abuse-deterrent properties is an important step toward reducing narcotic abuse while helping to "ensure access to appropriate treatment for patients in pain," the FDA said.
The draft guidance includes recommendations about studies that should be done to prove that a generic drug is no less abuse-deterrent than a brand-name one. The FDA is asking for feedback from the generic drug industry during a 60-day comment period.
On Tuesday, the FDA announced that certain opioid drugs -- such as Oxycontin, Percocet and Vicodin -- will get new "boxed warnings" about the dangers of misuse.
And last week, the U.S. Centers for Disease Control and Prevention announced new recommendations for doctors who prescribe such drugs.
The CDC advisory stressed that doctors -- especially primary care physicians -- should try to avoid prescribing addictive opioid painkillers whenever possible for patients with most forms of chronic pain.