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GPhA Praises President Obama’s Support for Safe and Affordable Biogenerics as Critical Solution to America’s Ailing Health Care System

Arlington, VA, February 26, 2009 – The Generic Pharmaceutical Association (GPhA) today applauded President Obama’s budget proposal for including a workable approval pathway for biogenerics that will substantially reduce health care costs by increasing access to quality care at affordable prices. The President’s budget proposal would ensure that this process mirrors the proven Hatch-Waxman market exclusivity model, by ensuring that brand companies cannot extend exclusivity using “ever-greening.”

“For patients across the country suffering from cancer, diabetes and other diseases, the support stated by President Obama today for a workable biogenerics approval pathway is lifesaving news. With countless patients struggling to pay the high costs of brand biopharmaceuticals, an approval pathway for safe, effective and affordable biogeneric medicines that provides access sooner rather than later is desperately needed. GPhA applauds the President’s budget message specifically stating that a workable scientific, regulatory and legal pathway with exclusivity provisions consistent with the Hatch-Waxman model must be enacted. The exclusivity provisions of Hatch-Waxman have been a successful model, fostering innovation and competition while saving hundreds of billions of dollars, and this same success can be achieved with biogenerics,” stated GPhA President and CEO Kathleen Jaeger.

“GPhA, AARP and numerous employers, labor, consumer and other organizations have consistently called for the creation of a workable approval pathway for biogenerics. We are pleased that the budget proposal specifically calls for: (1) creation of such a pathway; (2) biologic market exclusivity incentives consistent with ‘the principles in the Hatch-Waxman law for traditional products;’ and (3)‘brand biologic manufacturers would be prohibited from reformulating existing products into new products to restart the exclusivity process, a process known as ever-greening.’ The President clearly recognizes that unprecedented and unwarranted ever-greening provisions will only delay patient access to needed medicines and do nothing to lower health care costs.

“Controlling health care costs is a key component of the President's health care reform agenda and a critical step to putting our economy back on track. It is anticipated that by 2012, nearly half of all prescription drugs in the United States will be biologic products. As our elected officials grapple with serious economic and health care challenges, increasing access to generic and biogeneric medicines will significantly reduce health care costs and strengthen the availability of high quality health care,” Jaeger concluded.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 67% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs. For more information about the industry, visit www.gphaonline.org.

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