Economic Analysis of Availability of Follow-on Protein Products. Policy Relevance


As described above, several legislative proposals were before the 110th Congress that sought to establish an abbreviated regulatory pathway for FoPPs. Similar bills have begun to come before the 111th Congress, as the Administration and leaders in Congress have given high priority to legislative means for lowering the cost of drugs.[48] The results of an unbiased analysis of cost savings from FoPPs may be helpful in evaluating these proposals. For instance, this analysis explores how specific elements of legislative proposals (e.g., requirements for issuance of FDA guidance) may influence cost savings associated with FoPPs. A better understanding of the associations between legislative provisions for the regulatory pathway and potential cost savings may inform debate among policymakers as this pathway is established. If an abbreviated regulatory pathway is to be implemented, this modeling approach can provide a basis for estimating anticipated cost savings.

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