Case Study: Cole-Bishop

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The supposed main benefit of the Cole-Bishop bill and its predecessor the Cole-Bishop amendment to the FDA appropriations bill is that it changes the predicate date from February 2007 to the date 21 months after enactment of this new bill or 21 months after the effective date of deeming regulation. The passage of this bill would be tantamount to acquiescing to PMTA’s for the industry moving forward which would naturally mean a consolidation of the industry over the next decade as smaller manufacturers are unable to bring new products to market. Once PMTA’s are in place, it is very unlikely Congress would ever be repealed. Cole Bishop represents a path towards greater consolidation within the industry. Consolidation that will lead to less
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