[Ip-health] Drug companies gear up for 12 years of data exclusivity on small molecules

James Love james.love at keionline.org
Tue Jan 25 07:10:13 PST 2011


Following success in getting 12 years of exclusivity for biologic drugs,
the pharma industry is now trying to get 12 years for small molecules.
This is the abstract from a recent article in Health Affairs, that was
funded by INTERPAT, an association of research-based pharmaceutical
companies, and by the National Institute on Aging through its support of
the Roybal Center for Health Policy Simulation.  


doi: 10.1377/hlthaff.2009.1056
HEALTH AFFAIRS 30,
NO. 1 (2011): 84–90
©2011 Project HOPE—
The People-to-People Health
Foundation, Inc.

By Dana P. Goldman, Darius N. Lakdawalla, Jesse D. Malkin, John Romley,
and Tomas Philipson
The Benefits From Giving Makers
Of Conventional ‘Small Molecule’
Drugs Longer Exclusivity
Over Clinical Trial Data

ABSTRACT Pharmaceutical companies and generic drug manufacturers have
long been at odds over “data exclusivity” regulations. These rules
require a waiting period of at least five years before generic drug
companies can access valuable clinical trial data necessary to bring
less expensive forms of innovative drugs to market. Pharmaceutical
companies want the data exclusivity period lengthened to protect their
investment. Generic manufacturers want the period shortened so that they
can bring less expensive versions of drugs to patients sooner. We
examine the long-term effect of extending the data exclusivity period
for conventional “small-molecule” drugs to twelve years—the same
exclusivity period already extended to large-molecule biologic drugs
under the Affordable Care Act. We conclude that Americans would benefit
from a longer period of data exclusivity.


..........  text from the body........

Discussion And Policy Implications 

As noted above, the National Academies Committee on Science,
Engineering, and Public Policy2 and the pharmaceutical company
Glaxo-SmithKline3 have proposed increasing the data exclusivity period
for conventional drugs, as several European countries have done.  . . . 

Our research suggests that providing such an extension would spur
innovation that would benefit future generations. However, it remains to
be seen whether policy makers will embrace the necessary legislation,
given that the full value and potential cost savings to the health care
system would not be immediate.


----------------------
This research was funded by INTERPAT, an association of research-based
pharmaceutical companies, and by the National Institute on Aging through
its support of the Roybal Center for Health Policy Simulation
(P30AG024968). The authors are solely responsible for the content.

-- 
James Love, Director, Knowledge Ecology International
http://www.keionline.org | http://www.twitter.com/jamie_love
Wk: +1.202.332.2670 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.6584





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