Consumer & Health Groups, State Legislators, Experts React to Vote to Add Generic Biotech Drug Proposal to Health Care Reform Bill


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

* Sarah Rimmington, Attorney, Essential Action, Access to Medicines Project, Tel: (202) 387-8030 or Cell: (202) 422-2687, [email protected] *
“The biogenerics proposal adopted today torpedoes the objective of health care cost containment. The Eshoo proposal only offers the illusion of price-lowering generic competition for biotech drugs like Roche-Genentech’s $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’s hard not to wonder if the $1 million per day Big Pharma and Biotech spends lobbying influenced today’s vote.

But it’s 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’t afford for them not to.”

* Larry McNeely, Health Care Advocate, US PIRG (Public Interest Research Group), (202) 546-9707 x 303, [email protected] *
“The biologics measures passed today are nothing more than a bailout for Biotech and Pharma.”

Joana Ramos, MSW , Director, Washington Coalition for Prescribing Integrity and cancer survivor, Seattle, WA (206) 229-2420, [email protected]
“Patient 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.”
James Love, Director Knowledge Ecology International (KEI),
(+1) (202) 361-3040, [email protected]

“Health 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.”

* Sidney M. Wolfe MD, Public Citizen, Acting President and Director, Health Research Group (202) 588-7735, [email protected] *
“At 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.”

*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, [email protected] *
“In 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.”

*Maine Representative Sharon Treat, Executive Director, National Legislative Association on Prescription Drug Prices (NLARx), [email protected] or [email protected] *
“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, [email protected] *
“Everyone assumes that biosimilar entry will occur when the data exclusivity
period expires, but many aspects of the bill should be improved in order to
make that more likely.

“First, 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.”