GPhA Calls Senate Generic Biopharmaceuticals Hearing a Significant Movement Toward Increasing Consumer Access to Costly Medicines

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WASHINGTON, June 23 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today called the Senate Judiciary Committee hearing on generic biopharmaceuticals a significant movement toward saving American consumers billions of dollars on these drug products. The hearing, chaired by Senator Orrin Hatch, sought testimony from experts in the generic and biopharmaceutical industries on the establishment of an efficient and effective regulatory pathway that will enable FDA approval of more affordable, generic versions of expensive biopharmaceutical products. Experts representing GPhA and the generic industry explained how the science exists today for approving affordable biopharmaceuticals, and urged Congress to open the regulatory pathway to foster competition in this $30 billion a year marketplace. "Twenty years ago, the landmark Hatch/Waxman legislation established the modern generic pharmaceutical industry that currently creates consumer savings of more than $10 billion each year," said Kathleen Jaeger, GPhA President & CEO. "The science to create safe and effective generic biopharmaceuticals exists today. What is lacking is federal legislation that will establish a definitive and efficient process for FDA approval. Now is the time for Congress to act to give American consumers access to additional prescription drug savings for these products." "With biopharmaceuticals a major driver of increases in pharmaceutical spending, it is imperative that Congress create legislation that will authorize generic competition in this arena, to both provide significant savings to consumers and this Nation's health care system," Jaeger continued. "Based on the Hatch/Waxman model for traditional pharmaceuticals, we believe that price competition resulting from the approval of generic biopharmaceuticals will accomplish three important goals: increase the incentive for biotech companies to continue to invest in new therapies; offer consumers access to safe and effective generics at substantial savings; and increase consumer access to a greater array of pharmaceutical products -- traditional and biopharmaceutical drugs." Currently, there are more than a dozen biopharmaceuticals for which U.S. patents have expired, or will expire within the next few years. GPhA noted that the introduction of generic versions of these products would translate into a significant cost savings for the consumers. GPhA experts informed the panel that advances in science over the past 20 years support the development of safe and effective generic biopharmaceuticals, and called on Congress to establish an efficient regulatory process that will enable timely and cost-effective FDA approval of affordable biopharmaceuticals. "GPhA and its member companies are committed to working with members of the Congress to create landmark 21st century legislation that will further open the door to allow greater pharmaceutical savings by enabling the introduction of FDA-approved affordable biopharmaceuticals," 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 51% of the total prescriptions dispensed in the United States, but less than 8% of all dollars spent on prescription drugs. The Generic Pharmaceutical Association is committed to improving lives for less. For further information, please contact GPhA at 703-647-2480, or visit our web site at http://www.gphaonline.org/. SOURCE Generic Pharmaceutical Association