<nobr>Mar 12, 2009</nobr>

ERIC Urges Congress to Enact Pathway for FDA Approval of Biogeneric Drugs

Washington, D.C. -- The ERISA Industry Committee (ERIC), a Washington, D.C.-based trade association representing America's major employers, urges Congress to pass "The Promoting Innovation and Access to Life-Saving Medicines Act," legislation that would authorize the production of generic biologic prescription drugs -- or biogenerics -- making cutting-edge drugs affordable for millions of Americans.

The bill was introduced this week by House Energy and Commerce Committee Chairman Henry Waxman, with chief co-sponsors Chairman Frank Pallone and Ranking Member Nathan Deal of the Subcommittee on Health, as well as Representative Jo Ann Emerson.

"We have been urging Congress to establish a glide path for FDA approval of biogeneric drugs for several years," said ERIC President Mark Ugoretz. "The time for action is now. Legislation is needed that strikes an appropriate balance by enabling access to these life-saving drugs for American working families, while respecting a reasonable period of market exclusivity by brand name pharmaceutical companies upon whose innovation and research we rely."

Biologics are some of the most effective treatment options for breast cancer, leukemia, multiple sclerosis, HIV/AIDS and other serious conditions. However, these drugs can cost tens of thousands of dollars a year.

These drugs are often made from human cell tissues, proteins, or nucleic acids and have a high degree of molecular complexity compared to traditional formularies. The slightest deviation in replicating a brand drug -- after the patent expires -- for the purposes of manufacturing a generic version can have significant clinical consequences. Therefore, the Food and Drug Administration (FDA) has deemed additional legislation necessary to establish a separate process for approving generic biologics that ensures changes from the brand version do not have dangerous unintended clinical consequences and side effects. This has prevented cheaper alternatives to brand biologics from coming onto the marketplace.

The Promoting Innovation and Access to Life-Saving Medicines Act will allow brand biologic manufacturers up to eight years of market exclusivity, the same length under the current Waxman-Hatch law, which applies to traditional formularies. While the bill provides resources and authorization to the FDA to test proposed biogenerics for safety and efficacy, it does not statutorily mandate a specific process for doing so.

Ugoretz said that, "the savings generated by biogeneric alternatives will stem the tide of rising group health costs and reduce employee cost-sharing. Savings to federal and state programs will also be significant, and can be used to underwrite broad scale coverage and quality reform investments. Congress should respond to the broad consensus by health care stakeholders and pass a bill that lays out a pathway to FDA review and approval of biogenerics."

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For more information:
Ted Godbout
Manager, Communications
The ERISA Industry Committee
1400 L Street, NW, Suite 350
Washington, DC 20005
Phone: (202) 789-1400
Fax: (202) 789-1120
tgodbout@eric.org
www.eric.org

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The ERISA Industry Committee (ERIC) is a non-profit association committed to representing the advancement of the employee retirement, health, and compensation plans of America's largest employers. ERIC's members provide benchmark retirement, health care coverage, compensation, and other economic security benefits directly to tens of millions of active and retired workers and their families. ERIC has a strong interest in proposals affecting its members' ability to deliver those benefits, their cost and their effectiveness, as well as the role of those benefits in the American economy.

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