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The “Inevitability” of Biogenerics Takes Center Stage at GPhA’s Annual Meeting

Chairman Henry Waxman, Leading Generic Industry CEOs and BIO President Jim Greenwood Make Their Case for Biogenerics Legislation

Naples, FL, February 24, 2009 – As the Generic Pharmaceutical Association (GPhA) kicked-off its 25th anniversary celebration of the signing of the Hatch-Waxman Act, House Energy and Commerce Committee Chairman Henry Waxman told Annual Meeting attendees that “a workable scientific regulatory and legal pathway for biogenerics and biosimilar pharmaceuticals will ensure more affordable medications for Americans and we believe it will spur innovation in the bio tech markets.” Additionally, Chairman Waxman argued that the Hatch-Waxman model of market exclusivity would work well for biogenerics.

“One of the biggest sticking points in the debate over biogeneric legislation will be the number of years of exclusivity to which brand companies are entitled. The brand industry is calling for 12, 14, 16, and even 20 years of exclusivity. It makes my head spin trying to keep up with their ever changing arguments for why these terms are justified,” Chairman Waxman stated in video remarks to GPhA’s Annual Meeting. “I may be biased, but the Waxman-Hatch model has worked well for 25 years. It achieves a strong balance between fostering innovation and making affordable medicines available to consumers. There is no reason why this same balance cannot be achieved with biogenerics.”

Chairman Waxman went on to note that bringing biogeneric competition into the marketplace will result in cost savings and creating an approval pathway “will be an important contribution to health care reform…. I intend to use my position as Chairman to improve the health and well being of this nation and I know that a critical piece of achieving that goal is to bring generic competition to the bio tech drug market. The ballooning costs of these drugs are unsustainable and I want to work with the President, my Committee, all my colleagues in the Congress and the full array of stakeholders to get this job done.”

Following Chairman Waxman’s video remarks, leading generic industry CEOs participated in GPhA’s first ever “CEOs Unplugged” session and reiterated the critical need for Congress to pass biogenerics legislation to bring competition into the biopharmaceutical sector and lower health care costs. Their comments were reiterated by GPhA President and CEO Kathleen Jaeger during a lively biogenerics panel discussion with BIO President and CEO Jim Greenwood. During this panel discussion, both Jaeger and Greenwood agreed that biogenerics legislation has gained momentum, but as Jaeger noted, “the devil is in the details.”

Greenwood stated that there should be follow-on biologics; that they can be “safe and effective”; they can produce competition; and will provide savings. He also reiterated BIO’s position that there should be 14 years of market exclusivity.

Jaeger emphasized that what has become clear as momentum has surged for biogenerics legislation is that “biogenerics are achievable, imperative and inevitable.” Jaeger made the case that no less than 42 companies – both brand and generic – were actively engaged in biogeneric development and that FDA has clearly stated that the science exists to ensure safety and efficacy.

“Yes, the devil is in the details. We know the issue of exclusivity is likely the ‘gordian knot’ that must be cut loose for us to reach consensus and get legislation passed,” Jaeger stated. “The generic industry has 25 years of experience that shows the balanced approach under Hatch-Waxman is a sound and successful model to use for biogenerics. We can achieve competition and innovation – we’ve done it before and we can do it again.”

Jaeger concluded by saying to BIO that “it’s up to all of us. Working together, we can truly help improve the lives of countless Americans who need safe and affordable lifesaving medicines.

Greenwood concluded that he was confident that “we’ll find enough common ground to serve patients.”

Tomorrow’s session of the GPhA Annual Meeting will feature:
• A look at the year ahead for GPhA from GPhA President Kathleen Jaeger
• Remarks from FDA’s Director of the Office of Generic Drugs Gary Buehler
• A Presentation by Uwe Reinhardt, Princeton University Professor of Economics, on “Health Care and the Economy”
• An overview of generic industry business trends from Doug Long, Vice President of Industry Relations, IMS Health
• Remarks by Paul Vogel, former FDA Director, Division of Manufacturing and Product Quality, on “Global Supply Chain Security”

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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