[Ip-health] Consumer & Public Health Groups, State Legislators Ask Congress To Oppose Biogenerics Proposal

[Sarah Rimmington]

Today, Essential Action along with the National Women's Health Network,
Community Catalyst, Breast Cancer Action, National Legislative
Association on Prescription Drug Prices (NLARx), Knowledge Ecology
International (KEI), American Medical Student Association (AMSA) and
Universities Allied for Essential Medicines (UAEM) sent a letter to
Members of Congress asking them to oppose legislative proposals for the
approval of generic biologic drugs that contain excessive periods of
data exclusivity or other unnecessary and significant barriers to
generic biologic competition.

"Our nation is experiencing massive healthcare costs during an economic
crisis," says the letter. "Increasing the availability of generic
biologics will be a critical element of a comprehensive and necessary
health care cost containment strategy, and will provide Americans
affordable choices in their healthcare. If the wrong legislation passes
on this critical issue there will be no generic biologics and patients
and a teetering healthcare system will continue to pay the price."

The letter indicates that the proposal that recently passed the Senate
Health Committee, as well as a proposal being floated by Representative
Anna Eshoo in the House of Representatives propose excessive amounts of
data exclusivity and other unacceptable bureaucratic obstacles to
timely, price-lowering generic competition for biologics.

You can read the complete letter below.
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July 20, 2009

Dear Senator or Representative,

Congressional consideration of healthcare reform has two overriding
goals: expand health coverage to the uninsured, and contain costs. It is
widely understood that the first goal cannot be achieved absent success
with the second objective.

It is therefore vital that Congress take steps to lower the price of the
most expensive drug treatments, rather than aid Big Pharma and the
biotech industry's ability to price gouge consumers and the government.
For this reason, we urge you to support the Promoting Innovation and
Life Savings Medicines Act, H.R. 1427 and reject attempts to pass other
biologics legislation that will leave affordable care out of reach.

Over the past twenty-five years safe and affordable generic drugs have
been an important option for patients. However, there is an entire
category of medicines - biologics - that have no generic alternatives
because the FDA does not have the authority to approve them. Biologics
are among the most expensive and most important drugs available to
patients today. They account for 25% of all new drug products approved
by FDA and cost on average 22 times more than chemical drugs. Big Pharma
and the biotech companies charge so much more for biologics not because
they are more expensive to manufacture, or because research &
development (R&D) costs are higher, but simply because they can.
Presently, there is no competition in this critical marketplace.

The Senate HELP Committee and Congresswoman Eshoo have put forward
legislation that would grant unprecedented data exclusivity periods to
brand manufacturers, which will ensure there is long delayed or perhaps
even no generic competition. Both proposals, though very different in
many ways, would guarantee brand monopolies for at least 12 years and
give brands the ability to extend this monopoly even further. The
Federal Trade Commission (FTC) has closely examined this issue and
released a study stating that any amount of exclusivity is not necessary
to protect this industry. The Administration also opposes lengthy
exclusivity periods.

Our nation is experiencing massive healthcare costs during an economic
crisis. Increasing the availability of generic biologics will be a
critical element of a comprehensive and necessary health care cost
containment strategy, and will provide Americans affordable choices in
their healthcare. If the wrong legislation passes on this critical issue
there will be no generic biologics and patients and a teetering
healthcare system will continue to pay the price.

While it is disappointing, it is not surprising that one of the most
powerful lobbies in Washington has spent considerable resources to
ensure that they retain the ability to charge the highest prices that
the market will bear. Consumers and the healthcare system cannot bear
these prices any longer. We urge you to oppose generic biologics
legislation that contains excessive periods of exclusivity or other
unnecessary and significant barriers to generic biologic competition.
Don=92t let big industry interests trump sound public policy.

Yours truly,

American Medical Student Association (AMSA)

Breast Cancer Action

Community Catalyst

Essential Action

Knowledge Ecology International (KEI)

National Legislative Association on Prescription Drug Prices (NLARx)

National Women=92s Health Network

Universities Allied for Essential Medicines (UAEM)




Contact Person:
Sarah Rimmington, Attorney
Essential Action, Access to Medicines Project
srimmington@essentialinformation.org
(202) 387-8030
(Mobile) (202) 422-2687

--
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/