Drugmakers Question FDA’s Proposed Blister Packs for IR Opioids

Drugmakers have reservations about the FDA’s proposed blister pack requirements for certain immediate-release opioids, public comments show.

Some commenters questioned the  effectiveness of blister packs in curbing opioid abuse. Upsher-Smith Laboratories, for example, said unit-of-use blister packaging “will not solve the problems of misuse, abuse, inappropriate access and overdose, as blister packaging is not a deterrent nor an abuse resistant solution.”

Rhodes Pharmaceuticals claimed an estimated increase in per tablet cost of at least 125 percent and as high as 1,000 percent, depending on the individual drug product, the type of blister packaging, the supplier chosen, and the number of tablets per blister card.