Student and Consumer groups call on congress to create real pathway for generic biologics

September 28, 2009

Contact: Sara Crager, MD PhD, Yale University, and member, Universities Allied for Essential Medicines (UAEM)
Phone: (203) 444-4805 Email: [email protected]

Contact: Ethan Guillen, Director, Universities Allied for Essential Medicines (UAEM)
Phone: (775) 287-2553 Email: [email protected]**


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 “follow-on biologics” in Senate and House versions of healthcare reform legislation that purport to create such a pathway will actually block production of most 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,

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 years 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 “evergreening” 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 drug approvals, and include, among other things, most vaccines and treatments for 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 Organizations

Rebecca Mitchell, second- year medical student at University of California– San Francisco School of Medicine and Access to Medicines Campaign Director for the American Medical Student Association (AMSA), [email protected]

“As 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, which discourage innovation and raise costs for our health system.”

James Love, Director, Knowledge Ecology International, [email protected]

“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 that consumers will spend billions more on drugs. Congress needs to focus more on consumers, and give voters better reasons to choose them.”

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

“These proposals extending monopoly protection on biologics grimly remind us of the decade-long struggle to lower AIDS drug prices. To go down this road 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.”

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

“I applaud 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’s up to $72,000 per year cancer 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.”

Sara Crager*, MD/PhD Candidate, Yale University, and member of Universities Allied for Essential Medicines (UAEM) Mobile (203) 444-4805

“As 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 continue 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 reform 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 monopolybprotection 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.”

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’s mission is to ensure that people in developing countries have access to medicines developed in universities and that university medical research addresses the needs of the majority of the world’s population. As an organization which values innovation, we work to empower students to find new ways to improve access to health throughout the world.

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 practicing 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 at

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.

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.