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Biosimilar drugs
Urging the United
States Congress to
adopt balanced
legislation
providing incentives
for the creation and
development of next
generation, life-saving
biological drugs,
and, to encourage
the development of a
regulatory pathway
that allows cost-effective
biosimilar drugs to
be reviewed and
approved by the US
Food and Drug
Administration.
WHEREAS, it is the
mission of the
National Hispanic
Caucus of State
Legislators (NHCSL)
to promote
principles
supportive of the
Hispanic community
by developing and
advancing policies
that promote better
health outcomes for
consumers; and,
WHEREAS, the
National Institute
of Diabetes and
Digestive and Kidney
Diseases reports
that 10.4 percent of
Hispanics/Latinos
ages 20 years or
older have been
diagnosed with
diabetes*, and
slightly less than 1
in 2 Hispanic men
and 1 in 3 Hispanic
women will be
diagnosed with
cancer in their
lifetime --
accounting for 20%
of all deaths in
Hispanics in the US**;
and,
WHEREAS, bioscience
firms conduct
business in all 50
states, the District
of Columbia and
Puerto Rico and
legislative members
in the NHCSL are
actively
facilitating life
science discovery
which will lead to
significant economic
development
opportunities; and,
WHEREAS, many states
with legislative
members in the NHCSL
have research
universities and
bioscience companies
which play a key
role in the
discovery of cures
and treatments for
diseases that were
previously thought
incurable, and the
NHCSL wishes to
ensure that these
universities and
companies remain
viable to develop
medicines that
promote public
health, encourage
job creation and
foster economic
growth; and
WHEREAS, on average
it requires over
$1.2 billion and 10
to 15 years to
discover, develop
and secure US Food
and Drug
Administration (FDA)
approval to bring a
new biologic
medicine to the
market, and it is
imperative that
bioscience companies
are able to recoup
sufficient financial
returns to justify
investing in this
critically important
enterprise; and,
WHEREAS, the NHCSL
believes that
balanced biosimilar
legislation should
include a provision
that provides
pioneer bioscience
companies with at
least a reasonable
period of time of
exclusive use of the
costly, proprietary
data they must
produce to secure
FDA approval before
a biosimilar
manufacturer may
acquire this data
without cost; and,
WHEREAS, the NHCSL
wishes to ensure
that patient safety
is the primary
concern of the FDA
when approving both
pioneer and
biosimilar drugs,
and NHCSL recognizes
that biosimilar
manufacturers may
not be required to
duplicate all tests
required of the
pioneer manufacturer;
and,
WHEREAS, the NHCSL
believes that all
citizens will
benefit from more
affordable and more
innovative
biological medicines
to improve health
outcomes, as well by
the creation of jobs
and economic growth
associated with
bioscience research
and development
activities conducted
by universities and
the bioscience
industry;
NOW, THEREFORE BE IT
RESOLVED that NHCSL
urges the United
States Congress to
adopt balanced
biosimilar
legislation that
provides reasonable
incentives that will
foster the research
and development of
next generation,
life-saving
biological medicines
as well as job
creation and
economic expansion,
and, encourages the
creation of a
transparent, science-based
regulatory review
system that will
allow a fair and
prompt FDA review of
biosimilar products
so consumers may
benefit from
increased price
competition as soon
as appropriate.
BE IT FURTHER
RESOLVED that the
NHCSL is authorized
and directed to
transmit a copy of
this resolution to
members of the
United States
Congress.
(*)
http://ndep.nih.gov/diabetes/pubs/FS_HispLatino_Eng.pdf
(**)
www.cancer.org
This resolution
was adopted on
November 15, 2008,
at the National
Hispanic Caucus of
State Legislators
Executive Committee
Annual Meeting held
in Las Vegas,
Nevada.
Representative
Joseph Miró (DE),
NHCSL president
Sponsored By:
Senator Antonio
Muñoz (IL) |
