Pharma, Policy

FDA drafts guidance for generic drugmakers to create deterrents for painkiller abuse

Modifications from generic drugmakers could, say, make these drugs harder to crush and snort, smoke or dissolve to inject intravenously, as seen in a new FDA draft guidance.

celebrex pillsIn an effort to curb prescription painkiller abuse, the Food and Drug Administration is appealing to generic drugmakers to redesign medications like hydrocodone and oxycodone – creating abuse-deterrent formulations of these addictive drugs.

Such modifications could, say, make these drugs harder to crush and snort, smoke or dissolve to inject intravenously, as seen in a new FDA draft guidance.

“By issuing the draft guidance, the FDA is helping to ensure that generic abuse-deterrent opioids are no less abuse deterrent than their brand-name counterparts,” FDA Commissioner Robert Califf said in a press conference.

 

The published guidance indeed gives generic drugmakers some framework in which to modify their painkillers, so as to reduce their possibility of abuse. Since generic drugs are used more commonly than branded drugs – they’re cheaper and easier to access – such measures are even more critical, the FDA says.