[Ip-health] STUDENT AND CONSUMER GROUPS CALL ON CONGRESS TO CREATE REAL PATHWAY FOR GENERIC BIOLOGICS

[Anjali Dalal]

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Contact: Sara Crager

Phone: (203) 444-4805

Email: sara.crager@yale.edu



Contact: Ethan Guillen

 Phone: (775) 287-2553

 Email: ethan.guillen@essentialmedicine.org**
**
*
CURRENT PROPOSALS IN HEALTHCARE REFORM BILLS WILL BLOCK MOST GENERIC
BIOLOGICS***

Student and consumer groups, Universities Allied for Essential Medicines
(UAEM) and the American Medical Student Association (AMSA), supported by
consumer groups Essential Action and Knowledge Ecology International, are
today calling on Congress to create a real pathway for the production of
generic biologics.  Current proposals for generic biologics or =93follow-on
biologics=94 in Senate and House versions of healthcare reform legislation
that purport to create such a pathway will actually block production of mos=
t
generic biologics, which -- if the current proposals are improved in
critical ways -- could save $71 billion or more in the first decade alone.

The organizations involved support healthcare reform now, but urge Congress
to fix this serious challenge to future affordable access, both here and
abroad, which could also create tremendous savings for the healthcare
system.

To engage and educate consumers and patients from across the United States
in the fight for affordable medicines, UAEM and AMSA have launched a
website, http://www.AffordableMedsNOW.org<http://www.affordablemedsnow.org/=
>
.

The proposals, originating from legislation sponsored by Representative.
Anna Eshoo (H.R. 1548) in the House and counterparts in previous Congresses
in the Senate, have two major flaws.  First, the proposals will provide an
excessive 12-year period of market exclusivity for generic biologics while
other drugs receive a 5-year term, even though a 2009 PhRMA report notes
similar development costs for biologics ($1.2 billion) and conventional
drugs ($1.318 billion).  The Federal Trade Commission recommended zero year=
s
market or data exclusivity for biologics, as follow-on biologics will cost
more to bring to market for generic manufacturers than conventional
generics, among other unique circumstances, leaving originator companies
with 70%-90% of the market.  The difference will further distort
pharmaceutical innovation, which already fails to prioritize neglected
diseases, and will give undue advantage to biologics over conventional
drugs.  Second, the proposals will allow abusive =93evergreening=94 whereby
pharmaceutical companies will be allowed additional 12-year periods of
exclusivity for relatively inexpensive minor tweaks (for instance, making a
twice-a-day shot once-a-day) made to the originator biologics.  This could
block price-lowering generic competition indefinitely.

Representative Henry Waxman and Senator Charles Schumer have already
introduced alternative proposals (H.R. 1427/S. 726) that would better
address both problems with current proposals by allowing 5 years of
exclusivity and by blocking abusive evergreening.  The most troubling
aspects of the current biogenerics proposals in the healthcare bills should
be corrected by adopting the relevant parts of the Waxman-Schumer bills.

Unlike small molecule medicines like Tylenol and Prilosec, biologics are
complex macromolecules derived from living organisms and face higher
barriers to generic production than other drugs.  Biologics are the fastest
growing segment of the drug market, are predicted to soon be 50% of new dru=
g
approvals, and include, among other things, most vaccines and treatments fo=
r
cancer, multiple sclerosis, and rheumatoid arthritis.  The pharmaceutical
industry charges 22 times more for biologics than other drugs, and already,
the top six biologics make up over 40% of the Medicare Part B spending.

In the coming weeks, UAEM, AMSA, and supporters will be working to organize
students and others to let Congress know that patients, both here and in
developing countries, need REAL generic biologics legislation now.

###

*Statements from Experts and Participating Organization*

*Rebecca Mitchell*, second- year medical student at University of Californi=
a
=96 San Francisco School of Medicine and Access to Medicines Campaign Direc=
tor
for the American Medical Student Association (AMSA), rlmitchell1@gmail.com

=93As future physicians, we call upon Congress to ensure that life-saving
generic biologic drugs are made affordable and accessible to our
patients.  Language
in current health reform legislation creates biologic drug monopolies, whic=
h
discourage innovation and raise costs for our health system.=94

*James Love*, Director, Knowledge Ecology International,
james.love@keionline.org

"Congress should not give the drug companies a poorly conceived generic
pathway that will rarely be used.  There are all sorts of issues in the
pathway legislation, including not only the term of the monopoly, but also
the standards for generic entry, and the opportunities for evergreening
protection. The industry is spending millions to influence Congress, so tha=
t
consumers will spend billions more on drugs.  Congress needs to focus more
on consumers, and give voters better reasons to choose them."



*Athony So*, MD, MPA, Member UAEM Advisory Board, Professor of the Practice
of Public Policy Studies at Duke University=92s Terry Sanford Institute of
Public Policy, and Director, Program on Global Health and Technology

=93These proposals extending monopoly protection on biologics grimly remind=
 us
of the decade-long struggle to lower AIDS drug prices.  To go down this roa=
d
would be to condemn us to repeat this history for biologic treatments,
placing at risk the millions around the world who may need timely access to
affordable, life-saving medicines in the years to come.=94

*Sarah Rimmington*, Attorney, Essential Action's Access to Medicines
Project, Mobile (202) 422-2687

=93I laud the AMSA and UAEM students -- the doctors, medical researchers,
lawyers and other professionals of tomorrow -- for taking the initiative to
fight for real biogenerics legislation.  The proposals currently being
considered by Congress make a mockery of their purpose, to create an
approval process for safe, affordable generic biologic drugs.  Current
proposals offer only the illusion of price-lowering generic competition for
critical biotech drugs like Roche-Genentech=92s up to $72,000 per year canc=
er
treatment Herceptin.  By making relatively cheap and easy tweaks to old
biologic drugs near the end of the extra monopoly period, Big Pharma will
often be able to obtain indefinite monopolies, at best keeping affordable
biogenerics from pharmacy shelves several decades after their patents
expire.  These fake biogenerics proposals make no sense given the
inseparable twin objectives of health care reform, cost containment and
expanding coverage to all Americans.=94

*Sara Crager*, MD/PhD Candidate, Yale University, Mobile (203) 444-4805

=93As a PhD student and future biomedical researcher, I want the fruits of =
my
research to be available as widely as possible as soon as possible.  It is
vital to foster innovation incentives to ensure that new treatments continu=
e
to be developed, but even the most efficacious new treatments are of no
value if they are too costly to actually be available to the patients who
need them.  It is unjustifiable that Congress would allow health care refor=
m
to prioritize pharmaceutical company profits at the expense of patients.
Moreover, despite what its proponents claim they are advocating, this bill
will actually have the effect of deterring the development of truly
innovative new treatments.  Providing an additional 12 years of monopoly
protection for minor modifications to existent drugs will incentivize
low-risk research agendas and result in an onslaught of 'me-too' drugs,
slowing the discovery of the lifesaving drugs of the future.=94

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*About the Organizations***

About Universities Allied for Essential Medicines

Universities Allied for Essential Medicines (UAEM) is a coalition of
students at over 50 top research institutions across the United States,
Canada, the United Kingdom, and Germany.  UAEM=92s mission is to ensure tha=
t
people in developing countries have access to medicines developed in
universities and that university medical research addresses the needs of th=
e
majority of the world=92s population.  As an organization which values
innovation, we work to empower students to find new ways to improve access
to health throughout the world. www.essentialmedicine.org.

*About the American Medical Student Association*

The American Medical Student Association (AMSA), with more than a
half-century history of medical student activism, is the oldest and largest
independent association of physicians-in-training in the United
States.  Founded
in 1950, AMSA is a student-governed, non-profit organization committed to
representing the concerns of physicians-in-training.  With more than 62,000
members, including medical and premedical students, residents and practicin=
g
physicians, AMSA is committed to improving medical training as well as
advancing the profession of medicine.  To learn more about AMSA, our
strategic priorities, or joining the organization, please visit us online a=
t
http://www.amsa.org/. **

About Essential Action

Essential Action is a non-partisan, non-industry funded public health and
corporate accountability group based in Washington, DC. Our Access to
Medicines Project staff has worked on U.S. and global access to medicines
issues for more than a decade, focusing on patent and related barriers to
generic competition. www.essentialaction.org/access/

*About Knowledge Ecology International *



Knowledge Ecology International (KEI) is a not for profit, non-governmental
organization that searches for better outcomes, including new solutions, to
the management of knowledge resources.  KEI is focused on social justice,
particularly for the most vulnerable populations, including low-income
persons and marginalized groups.  KEI is particularly drawn to areas where
current business models and practices by businesses, governments or other
actors fail to address social needs, and where there are opportunities for
sustainable improvements.  KEI is an international organization with an
international board and staff and maintains offices in Washington, D.C. and
Geneva. www.keionline.org.

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