What Have We GAINed? An Analysis of Federal Incentive Policies in the Orphan and Anti-Infective Drug Markets
Abstract
The world faces a growing danger in the form of antibiotic resistance and a dwindling
anti-infective pipeline. To help combat the threat, Congress passed legislation (the
“GAIN Act”) in 2012 that grants five years of additional exclusivity—or protection
from competition from generic products—to drug applications that are designated as
qualified infectious disease products (QIDPs). The exclusivity incentive is nearly
a carbon copy of the hallmark design of the 1983 Orphan Drug Act, which was passed
to spur development of treatments for rare diseases.
This thesis addresses the effectiveness of incentive policies in facilitating drug
development in the orphan drug market for rare diseases and the anti-infective drug
market. Using pricing data from Medicare Part D program and drug databases, the research
develops frameworks for both the orphan and anti-infective markets and finds that
the two markets vary widely across all measured categories. During the course of the
past decade, anti-infectives became less of a priority in the development pipelines
of the world’s top pharmaceutical companies, and content analysis of earnings call
transcripts reveals that industry executives do not seem to be discussing the new
incentive. The results indicate that a new or augmented approach to anti-infectives
may be needed. Instead of using exclusivity, the government should consider offering
benefits that companies realize at the front end of the research and development pipeline
as a means to increase drug development in the anti-infective drug market.
Type
Honors thesisDepartment
Public Policy StudiesPermalink
https://hdl.handle.net/10161/11543Citation
Hoerger, Ryan (2016). What Have We GAINed? An Analysis of Federal Incentive Policies in the Orphan and Anti-Infective
Drug Markets. Honors thesis, Duke University. Retrieved from https://hdl.handle.net/10161/11543.Collections
More Info
Show full item record
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 United States License.
Rights for Collection: Undergraduate Honors Theses and Student papers
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info