Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.
Abstract
Chemoprevention agents are an emerging new scientific area that holds out the promise
of delaying or avoiding a number of common cancers. These new agents face significant
scientific, regulatory, and economic barriers, however, which have limited investment
in their research and development (R&D). These barriers include above-average clinical
trial scales, lengthy time frames between discovery and Food and Drug Administration
approval, liability risks (because they are given to healthy individuals), and a growing
funding gap for early-stage candidates. The longer time frames and risks associated
with chemoprevention also cause exclusivity time on core patents to be limited or
subject to significant uncertainties. We conclude that chemoprevention uniquely challenges
the structure of incentives embodied in the economic, regulatory, and patent policies
for the biopharmaceutical industry. Many of these policy issues are illustrated by
the recently Food and Drug Administration-approved preventive agents Gardasil and
raloxifene. Our recommendations to increase R&D investment in chemoprevention agents
include (a) increased data exclusivity times on new biological and chemical drugs
to compensate for longer gestation periods and increasing R&D costs; chemoprevention
is at the far end of the distribution in this regard; (b) policies such as early-stage
research grants and clinical development tax credits targeted specifically to chemoprevention
agents (these are policies that have been very successful in increasing R&D investment
for orphan drugs); and (c) a no-fault liability insurance program like that currently
in place for children's vaccines.
Type
Journal articleSubject
Antineoplastic AgentsBiomedical Research
Chemoprevention
Drug Discovery
Drug Industry
Humans
Intellectual Property
Liability, Legal
Neoplasms
Orphan Drug Production
Patents as Topic
Raloxifene Hydrochloride
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https://hdl.handle.net/10161/6433Published Version (Please cite this version)
10.1158/1940-6207.CAPR-08-0048Publication Info
Moe, Jeffrey L (2008). Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.
Cancer Prev Res (Phila), 1(2). pp. 84-90. 10.1158/1940-6207.CAPR-08-0048. Retrieved from https://hdl.handle.net/10161/6433.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Jeffrey Moe
Adjunct Professor of Global Health

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