505(b)(2) route doesn’t necessarily deliver faster approvals

A new Tufts review has found that when the 505(b)(2) pathway is used for new drug applications (NDAs), it does not always lead to shorter approval times.

The 505(b)(2) pathway specifically allows the US Food and Drug Administration (FDA) to rely on data not developed by or for the applicant. Such data many include FDA findings of safety and effectiveness and data previously generated for a reference drug. The pathway is therefore appealing to Sponsors because it offers the possibility of a shortened development time, reduced required data and decreased costs.

The Tufts analysis, which covered the period from 2009 to 2015, found that 63% of 451 original NDAs approved by the FDA were for drugs approved via the 505(b)(2) pathway, but mean approval times for such applications was nearly five months longer than that for new chemical entities (NCEs).

One finding from the review was that 505(b)(2) applications received substantially fewer expedited review designations than NMEs during the same period. This may be part of the explanation for loner approval time although it also appears these 505(b)(2) applications were ‘approval-ready’ as they could have been.

Joseph A. DiMasi, Director of Economic Analysis at Tufts CSDD and principal investigator for the study said “As with any drug development program, it’s important to engage proactively with the FDA to better understand the data needed to bridge a 505(b)(2) program with the approved reference product.” In our experience at Regulis this is sound advice. It is not uncommon for companies to miss the need for a robust bridge for their product to reference product and its dataset.

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