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“Retro.” “Vintage.” “Nostalgic.” These can be great terms to describe that classic car you have your eye on, but they are not great when describing your primary drug product packaging. Many of today’s drug products are still packaged with elastomer formulations and designs that were first developed over 50 years ago. Generic companies that simply replicate the innovator packaging could be affecting their operation negatively for many more years to come.

When the first Generic Drug User Fee Act (GDUFA I) was enacted in 2012, The FDA’s Office of Generic drugs (OGD) was trying to manage a growing backlog of regulatory applications. The introduction of user fees to the generic drug approval process permitted FDA to increase resources to address the increasing review and inspection demands. In addition, GDUFA I set forth performance goals for the FDA over a 5-year span, resulting in reductions in both the generic drug application backlog and application review times.