Purpose
– The Orphan Drug Act has provided the pharmaceutical industry with incentives to research and develop drugs for orphan diseases: rare diseases with little profit potential. It is considered very successful legislation by legal scholars, the Food and Drug Administration (FDA), and orphan drug activists. The policy process of the Act provides an important model of the policy process for future incentive-based pharmaceutical legislation. The purpose of this paper is to summarize the important incentives of the Act and the historical events leading up to the Act. The paper applies three different theoretical models of the public policy process to understand the emergence of the Orphan Drug Act: Kingdon’s Multiple Streams Model, the Advocacy Coalition Framework, and Social Constructionism Theory. The paper then synthesizes the public policy process lessons from each perspective and provides four recommendations for other social activists seeking to propel incentive-based pharmaceutical legislation for under-researched diseases.
Design/methodology/approach
– The author analyzes the history of the Orphan Drug Act based on publicly available scholarly research, government documents, and interest group publications. The author then applies three public policy theories to the history of the Orphan Drug Act to explain the emergence of the Act and to extract policy process lessons for future disease activists.
Findings
– Regardless of which theoretical perspective the Orphan Drug Act is analyzed from, some common themes of the policy process emerge. First, focussing events are instrumental in capturing the public’s sympathy and Congress’s attention. Second, in its activities and proposed legislation, a coalition should provide a role for all relevant and important actors. Third, the target groups of the legislation were construed positively, increasing the pressure for Congressmen to pass some kind of bill. Finally, the proper construction of “the problem” is instrumental to passing effective legislation as a “solution.”
Originality/value
– The Orphan Drug Act is widely considered successful incentive-based pharmaceutical legislation. However, because it was originally passed in 1983 and has not had public attention since the early 1990s (when it was amended), it has rarely been written about in recent years. However, its lessons are still highly relevant to policy activists, especially disease activists. Furthermore, existing articles focus on the impact of the legislation and ways to amend it, rather than on the passage of the Act.
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