The Food and Drug Administration (FDA) is pressuring manufacturers of generic opioid painkillers to reformulate their meds to make them more difficult to tamper with and abuse, the latest step in the agency’s fight to curb the national prescription drug abuse epidemic.
The draft guidance encourages generic drug makers to develop their pain medications with abuse-deterrent properties to help prevent certain types of abuse, such as crushing a tablet in order to snort, or dissolving a capsule in order to inject its contents. Abuse-deterrent formulations do not prevent abuse, addiction, overdose or death, the agency pointed out, but they could have some impact on the drug abuse crisis.
The FDA has approved five abuse-deterrent opioids. These painkillers make up a small number of the opioid drug market.
Generics, which make up the majority of the opioid market, are generally approved if makers can show their products are chemically equivalent to the original version. The new guidelines will require generic drug manufacturers to perform additional tests to show that their generic opioids have the same abuse-deterrent qualities as their brand-name equivalents. There is no timeline for generic manufacturers to update their currently available opioids.
“For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care,” said FDA Commissioner Robert Califf, M.D. “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. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy.”
The draft guidance for generic drug manufacturers follows new boxed warnings of abuse, overdose and death with fast-acting opioid drugs and new warnings for all opioids regarding increased risk of serotonin syndrome, adrenal insufficiency and decreased sex hormone levels.