Graduation Year

2018

Date of Submission

12-2017

Document Type

Campus Only Senior Thesis

Degree Name

Bachelor of Arts

Department

Government

Reader 1

Shanna Rose

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Rights Information

© 2017 Micaela Laber

Abstract

The health care industry’s involvement with biosimilar policies suggests that building coalitions and reducing opposition are critical factors for interest group success. As government decision-makers wrestle with how to handle a perplexing category of prescription drugs, companies and patient groups alike receive ample opportunities to contribute to the policymaking process. When stakeholders in the biosimilar arena – including manufacturers, physicians, and patients – unite, we see that the United States government takes steps toward fixing the policy problem. This occurred most recently with policies about biosimilar drug coverage under Medicare Part D and reimbursement under Medicare Part B. In both cases, stakeholders took a united stance and consequently faced no opposition. On the contrary, internal industry disputes between brand and biosimilar manufacturers about patent exclusivity laws and interchangeability rules revealed the nuances of biosimilar policy and the challenge that regulators face when they receive mixed messages. Across all of their efforts, biosimilar stakeholders pursued numerous strategies which may have contributed to their successes. They focused on niche issues and used their lobbying expertise to actively submit comments, testify in hearings, and meet with government officials; however, the differentiating tactic between the industry’s successes and failures was whether they formed coalitions. By coming together, stakeholders lowered their chances of facing opposition. A closer analysis of the politics of biosimilars illustrates that when they present a united front to lawmakers, interest groups reduce the likelihood of opposition and successfully influence policy change.

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