Promotion, Protection, and Entrepreneurship: Stakeholder Participation and Policy Change in the 21st Century Cures Initiative

Abstract

The Energy and Commerce Committee in the U.S. House of Representatives developed the 21st Century Cures Act through a factfinding process that involved many different stakeholders in the biotechnology field. This effort can be viewed as an example of policy entrepreneurship in that the committee was trying to accelerate the development of new drugs and treatments. Some members of the committee were very active in this process, while others were less engaged. This article investigates what factors influenced individual legislators participation level in the initiative. We consider whether there is evidence that legislator characteristics and the types of groups actively involved in the initiative contributed to some important viewpoints going unaddressed. The evidence supports a contention in the literature that legislators approach biotechnology with a promotional focus as opposed to placing an emphasis on protecting the public from harm, which may have led to potentially problematic changes in areas such as informed consent.Acknowledgements: The authors wish to thank

State Biotechnology and Genomic Development: Critical Resources and Barriers

“…Considerable research (Brant, Myers, and Runge ; Sheingate , ) has focused on the 21st Century Cures Act and other federal policies to promote the U.S. biotechnology sector. The goal of the 21st Century Cures Act (H.R.…”

“…As discussed in Brant, Myers, and Runge (), the promotion of biotechnology as an economic development tool at the state level was an outgrowth of the development of a product‐based federal regulatory system that gave the U.S. House Energy and Commerce Committee jurisdiction over medical technology. In that same article, consideration was also given to members of Congress acting as policy entrepreneurs (as discussed by Kingdon ) to advance biotechnology as an economic driver in the United States.…”

Note from the Editors

“…Next, Zimmermann and Kenter (2023) tackle democratic decision making and participative strategy development with a focus on contemporary environmental concerns (see also Brant et al, 2017; Bryson et al, 2008). Using the case of the England Peat Action Plan, the authors contend that tensions can appear between the initial framing of intended change, the persistence of stakeholders' different framings of it, and participants' perceptions of lacking knowledge, guidance, and control.…”

Explaining public policy change in a developing country: A case study of Ghana's forest and wildlife policy

“…In addition, the role of policy entrepreneurs (PEs) and actor coalitions in bringing new ideas and increasing the momentum for policy change have received reasonable attention in the extant literature (Arnold, 2021; Aviram et al, 2020; Brant et al, 2017; Font & Subirats, 2010; Mintrom & Norman, 2009; Palmer, 2015; Petridou & Mintrom, 2021; Wiering et al, 2017). The important question here has been, how do policy entrepreneurs get things done, or better still, what do they do to get policy changed?…”