[Ip-health] New briefing note: Congress Must Im prove “No Generics” Proposal for Biologic s

[Sarah Rimmington]

Essential Action has produced a new briefing note on the issue of the
generic biologic drug issue and in particular the major problems with
the U.S. regulatory pathway proposals that have been incorporated in to
draft health care reform legislation by house and senate committees.

You can review the first few paragraphs below.  You can download the
entire note at:
http://www.essentialaction.org/access/index.php?/archives/219-Congress-Must=
-Improve-No-Generics-Proposal-for-Biologics.html

To talk action and tell congress to improve these proposals, please take
action by calling congress or sending an email to your congresspersons
by consulting  http://affordablemedsnow.com/

Regards,
Sarah


Congress Must Improve “No Generics” Proposal for Biologics
Healthcare Reform Offers Only the Illusion of Generic Competition for
Biotech Drugs: Patient Access To Expensive New Medicines at Stake


U.S. Congress is considering proposals to establish a process for
regulatory approval of generic versions of biotech drugs ("biologics").
The Food and Drug Administration (FDA) approval process available for
conventional pharmaceuticals does not apply to biologics, which are
drugs engineered from human or animal cells using biotechnology. New and
different procedures are required to demonstrate the safety and efficacy
of comparable and interchangeable biologic pharmaceuticals (called
“biosimilars” or “biogenerics”).

Proposals passed by the Senate and House health committees as part of
healthcare reform in July 2009, however, will establish prolonged delays
before permitting price-lowering generic competition. Even worse, they
will facilitate brand-name companies’ ability to renew their monopolies,
potentially keeping generic firms out of the market for biologics
altogether and creating only the illusion of generic competition. Either
result will torpedo the objective of healthcare cost containment so
crucial to current reform efforts, and severely limit patient access to
these important and exceptionally high-priced medicines for conditions
like cancer, arthritis and diabetes.

The bottom line is this: Under these proposals, Medicare and other
federal programs will find their budgets increasingly strained by
growing biologic drug costs. Employers will continue to struggle to
provide affordable health insurance to their employees. Americans with
insurance will find it even more difficult to pay for their already
sky-high prescription drug co-payments. And the uninsured may have to go
without crucial lifesaving biologics.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/

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