[Ip-health] Consumer & Health Groups, State Legislators, Experts React to Vote to Add Generic Biotech Drug Proposal to Health Care Reform Bill

[Sarah Rimmington]

*FOR IMMEDIATE RELEASE*

* Essential Action * KEI * Public Citizen * U.S. PIRG *
* NLARx (National Legislative Association on Prescription Drug Prices) *
* Universities Allied for Essential Medicines *
* Washington Coalition for Prescribing Integrity *


Following are comments from consumer, public health and student groups,
state legislators and experts following today=92s House Energy & Commerce
Committee vote to add the Eshoo-Barton-Inslee generic biologics
(biogenerics or biosimilars) amendment to America=92s Affordable Health
Choices Act of 2009.


* Sarah Rimmington, Attorney, Essential Action, Access to Medicines
Project, Tel: (202) 387-8030 or Cell: (202) 422-2687,
srimmington@essentialinformation.org *
"The biogenerics proposal adopted today torpedoes the objective of
health care cost containment. The Eshoo-Barton-Inslee proposal only
offers the illusion of price-lowering generic competition for biotech
drugs like Roche-Genentech=92s $72,000 per year cancer treatment
Herceptin. By making cheap and easy tweaks to old biologic drugs, Big
Pharma will be able to obtain near perpetual monopolies and keep
affordable biogenerics from pharmacy shelves several decades after their
patents expire.

It=92s hard not to wonder if the $1 million per day Big Pharma and Biotech
spends lobbying influenced today=92s vote.

But it=92s not too late. Congress can stop Pharma from continuing to price
gouge the American public by fixing the biogenerics proposals on the
floor of the House and Senate. President Obama can demand changes before
signing a health care bill into law. We can=92t afford for them not to."


* Larry McNeely, Health Care Advocate, US PIRG (Public Interest Research
Group), (202) 546-9707 x 303, lmcneely@pirg.org *
=93The biologics measures passed today are nothing more than a bailout for
Biotech and Pharma.=94


* Joana Ramos, MSW , Director, Washington Coalition for Prescribing
Integrity and cancer survivor, Seattle, WA (206) 229-2420,
jdr@ramoslink.info
=93Patient and their families need relief from the exorbitant, and
ever-escalating prices, being charged for biologic medicines. Medical
innovations are of no value without access. Limiting the period of
marketing exclusivity to 5-7 years for these new drugs is an important
first step to solving the problem.

Almost every week my colleagues and I work with, or seek help for, not
only the uninsured, but increasingly also insured patients facing food
insecurity, evictions, foreclosures on their mortgages, bankruptcy, and
even relapse and untimely death just because of the price of biologic
drugs. In one recent case, an insured college student with rheumatoid
arthritis had a flare-up so severe that he had to be hospitalized, after
his 6-month co-pay grant for Kineret from an assistance program ended.
Because it took several more months for him to be able to get into a new
program, his parents, members of the squeezed middle class, then had to
put the monthly co-pays of $650 for Kineret on their credit card during
the wait. They now struggle with that debt plus the close to $10,000 of
the "patient responsibility" portion of the hospital bills, plus
insurance premiums that have almost doubled since 2006. Patients with RA
are thought to need these drugs for the rest of their lives.

Compared to many biologic cancer drugs however, Kineret is a "bargain,"
at some $1400/month. Drugs like Herceptin and Tykerb run in the multiple
thousands of dollars per month, and 4-figure co-pays are common.=94


* James Love, Director Knowledge Ecology International (KEI),
(+1) (202) 361-3040, james.love@keionline.org *
=93Health Care reform is both about extending coverage to everyone, and
being smarter about how we spend money. A 12.5 year or more monopoly for
biologic medicines, without any safeguards to protect consumers and
taxpayers is hardly smart. Congress could have embraced a shorter
monopoly, or provided protections against excessive pricing. The
Eshoo-Barton amendment also makes it easier for companies extend the
monopoly, through small changes in the products, and by creating areas
where litigation over nuances in the incumbent friendly rules will block
generics.

The negotiations over biogenerics is an example of how the US Congress
can be controlled by big money, on a topic that concerns everyone as
consumers, employers and taxpayers. We can't have a sustainable system
for access to health care without paying attention to costs.=94


* Sidney M. Wolfe MD, Public Citizen, Acting President and Director,
Health Research Group (202) 588-7735, Swolfe@citizen.org *
=93At a time when there is a need to control health expenditures, this
unwarranted patent gift to the Biotech industry guarantees that tens of
billions of dollars will be wasted by shutting out, for an additional 7
years or more, generic companies from making equally safe and effective
biogeneric drugs.=94


*Sara Crager, MD/PhD Candidate '12, Yale University, Universities Allied
for Essential Medicines (UAEM), (203) 444-4805 *
"I hope to one day see my research developed into biologic therapeutics.
While fostering innovation incentives is key to ensuring this future
development, ultimately, I want my current and future research to have
the greatest possible impact on humanity. As such, I want the fruits of
my research to be available as widely as possible as soon as possible.

Particularly in a university setting, where the vast majority of
research is supported by public funding, advancing broad access to
innovative new treatments should be the priority, not profit. The
American Association of Universities (AAU) has come out in support of
the proposal that passed today, which contains data exclusivity and
ever-greening provisions that go far beyond the need to preserve the
incentives for innovation. I find it paradoxical that the university
community that is training me to make scientific discoveries to improve
the human condition is taking a stance that obstructs the potential
future impact of these discoveries."


* Ethan Guillen, Executive Director, Universities Allied for Essential
Medicines (UAEM) (Cell) (775)287-2553, ethan.guillen@essentialmedicine.org =
*
=93In a year that we were promised change, it is exceedingly disappointing
to see Congress continue to play the role of the guardian of corporate
profits rather than the champion of patients. Even more disappointing is
the role universities, specifically the American Association of
Universities, have played in pushing for this unprecedented monopoly for
pharmaceutical companies, which in the end will harm patients in the
U.S. and the poor in developing countries. There is simply no evidence
that such a long period of exclusivity is necessary to promote
innovation. Worse, the evergreening provisions that have emerged could
extend these monopolies for decades.

The universities regularly speak of their devotion to improving access
to medicines in poor countries, while Congress speaks of restraining out
of control health care costs, but their actions speak louder than their
words. We must continue to fight to ensure that the final bill
reasonably addresses biosimilars with an appropriate balance between
access and innovation.=94


*Maine Representative Sharon Treat, Executive Director, National
Legislative Association on Prescription Drug Prices (NLARx),
streat@reducedrugprices.org or nlarx@gwi.net *
"The ready availability of generic versions of biotech pharmaceuticals
is a key component of any strategy to extend health care to all
Americans. These drugs are a growing and especially costly share of
state Medicaid budgets, and it is crucial that any federal health reform
limit the time for exclusivity to ensure competition and ensure that
these life-saving medications are available to doctors and their
patients at a reasonable price."


*Kevin Outterson, Associate Professor of Law, Boston University, (617)
353- 3103, mko@bu.edu *
"Everyone assumes that biosimilar entry will occur when the data exclusivit=
y
period expires, but many aspects of the bill should be improved in order to
make that more likely.

=93First, companies should not receive patents and data exclusivity
periods unless they have fully described both the molecule and its
formulation process (akin the enablement doctrine in patent law). Full
disclosure is the quid pro quo in exchange for patents and exclusivity.
If "the process is the product," as the companies often say, then the
process must be fully disclosed. Otherwise, biosimilar entry will be
very difficult and cost savings will not materialize.

Second, for safety purposes, the companies and the FDA should fully
disclose the submission package as early as possible, with the companies
protected from free riding by marketing (not data) exclusivity.

Third, data exclusivity periods should not be retroactively applied to
existing molecules where the patents are long-expired.

Finally, Hatch-Waxman works in tandem with aggressive state laws on
generic substitution, a structure that is missing in the biosimilar
arena. A federal law of biosimilar substitution should be included, with
appropriate modifications, and it should not pre-empt more aggressive
state laws promoting substitution."



--
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/