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GPhA: Obama Administration Says it Will Continue to Push for Seven Years of Market Exclusivity for Biogenerics

HHS Secretary Sebelius and FDA Principal Deputy Commissioner Dr. Sharfstein Tell GPhA Annual Policy Conference that Increasing Access to Generics and Biogenerics Is Key to Reducing Health Care Costs

Washington, DC, September 17, 2009 – Speaking to attendees at the Generic Pharmaceutical Association’s (GPhA) Annual Policy Conference, Health and Human Services Secretary Kathleen Sebelius strongly stated that the Obama Administration remains committed to pushing for seven years of market exclusivity for novel biologic products in health care reform legislation pending on Capitol Hill. She went on to say that the Administration also rejected exclusivity for evergreening products. The Secretary noted that she believes the President took a strong stance on exclusivity and the Administration will work with Congress as health care reform discussions continue, stating, “You have allies in the President of the United States and the Department.”

Secretary Sebelius also emphasized that while it is critical to increase access to biogenerics to save lives and reduce health care costs, this can be done while also preserving innovation in the brand biopharmaceutical sector. This is an important piece of the public health agenda given that the top four biologics alone represent a significant part of overall pharmaceutical expenditures.

Echoing Secretary Sebelius’ comments, FDA Principal Deputy Commissioner Joshua Sharfstein, M.D., stated that biogenerics were needed for patients grappling with the high costs of brand biopharmaceuticals. He noted that, in meeting with patient groups, he and FDA Commissioner Margaret Hamburg, M.D., consistently heard that access to biogenerics is a priority for patient groups because high costs were leading patients to either skimp on treatment or go without treatment altogether.

In addition to stressing the need for a reasonable seven-year period market exclusivity paradigm – which is devoid of evergreening provisions - Secretary Sebelius stated that the arguments for health care reform parallel the arguments for greater use of generic medicines. Generic medicines have successfully proven that it is possible to increase access to quality of care while also lowering costs. The Secretary said that HHS supported proposals “that would bring more generics forward” including those that would reduce the backlog of generic applications at FDA and “help Americans get access quicker.”

Dr. Sharfstein emphasized the Agency’s commitment to reducing the backlog and noted that FDA has been working with GPhA on this issue, including the possibility of implementing generic drug user fees. “GPhA has long stated that FDA needs more resources to review and approve generic medicines and the industry is open to user fees. We look forward to working with the Agency in developing a meaningful user fee program that achieves our shared goal of ensuring timely consumer access and we welcome the Agency’s commitment to working with us to achieve this goal,” GPhA President and CEO Kathleen Jaeger stated.

“As the generic pharmaceutical industry celebrates the 25th anniversary of the signing of the Hatch-Waxman Act next week, GPhA welcomed both Secretary Sebelius’ and Dr. Sharfstein’s acknowledgement of the importance of this legislation. As Dr. Sharfstein stated, the Hatch-Waxman Act “is one of the most important pieces of public health legislation of our time.

“We are grateful that the Obama Administration recognizes the overwhelming public health benefits that generic medicines bring to consumers and the entire health care system,” Jaeger noted. “The Administration’s support for seven years of market exclusivity for biogenerics is critical to the more than 70 organizations representing millions of consumers, businesses and seniors advocating for a biogenerics pathway that gets these life-saving medicines to patients sooner rather than later.”

Sharing with conference attendees that generic medicines save the health care system an extraordinary one billion dollars every three days, Jaeger stated that these savings are “a testament to our strong record of producing safe and effective medicines at affordable prices. And it’s a testament to the confidence that consumers have placed in our products. They know that when they take generic medicines, they are getting the same medicines, delivering the same benefits as brand names drugs, but at much lower costs. That’s why generics – and biogenerics – are the right solution for better health – and the right solution for Congress as it grapples with health care reform. As Secretary Sebelius stated, generics provide a proven effective means of lowering costs while also increasing access to quality care.”

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 69% of the total prescriptions dispensed in the United States, but only 16% of all dollars spent on prescription drugs. For more information about the industry, visit www.gphaonline.org.
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