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02-19-2008, 07:43 PM
More than 400 generic industry leaders, financial experts and political officials gathered today for the Generic Pharmaceutical Association (GPhA) Annual Meeting to discuss the critical issues facing the generic industry in 2008. With the theme of "Generics: The Right Choice for Better Health," conference participants discussed the industry opportunities and challenges in this important legislative and election year.

"Voters are going to the polls with access to affordable health care at the top of their minds," said GPhA President Kathleen Jaeger. "Generics-and biogenerics-are the solution to reducing health care costs while increasing access to quality care. With generics saving consumers and the federal government billions of dollars a year, it's clear that generics are the right choice for better health."

Today 65% of all U.S. prescriptions dispensed are filled with generics, at costs of 30% to 80% less than brands. This offers substantial savings for consumers, state governments and the health care system. In fact, a 1% increase in generic use saves consumers $4 billion annually.

On Capitol Hill and in state capitals across the country, the generic industry will be working to help consumers receive greater access to affordable medicines by:

-- Encouraging passage of federal legislation to create a safe and workable Food and Drug Administration (FDA) approval pathway that provides timely access to biogeneric medicines. Brand biopharmaceutical medicines can cost hundreds of thousands of dollars per patient, per year. Safe and effective generic versions of biopharmaceutical medicines, or biogenerics, would save consumers billions of dollars and provide countless patients with access to lifesaving treatments.

-- Removing longstanding barriers to consumer access to generics including:

- Ensuring that FDA implements the citizen petition law passed by Congress in 2007 to curb brand drug company efforts to delay generic competition.
- Blocking the marketing of an authorized generic (the brand company's own product repackaged and marketed either through a subsidiary or third party) during the 180-day exclusivity period awarded to the first generic competitor.

-- Providing sufficient supplemental Congressional funding for the FDA's Office of Generic Drugs Increasing FDA-industry communications.

-- Addressing changes to the Medicaid pharmacy reimbursement rules to ensure that they do not harm consumers' access to generics.

-- Approving free trade agreements, similar to the recent U.S.-Peru Free Trade Agreement, that balance pharmaceutical innovation with access to affordable generic medicines.

-- Enacting legislation to promote e-prescribing to increase patient safety.

-- Stopping state "carve out" legislation that bars generic substitution for various therapeutic classes of medicines. Carve outs cost states millions of dollars.

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 65% of the total prescriptions dispensed in the United States, but only 20.5% of all dollars spent on prescription drugs.

Generic Pharmaceutical Association (http://www.gphaonline.org/)