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GPhA: Senator Hatch and Chairman Waxman Stress Important Role Generic Medicines Play in Strengthening Health Care System on 25th Anniversary of Hatch-Waxman Act

Chairman Waxman States “War is Not Over” in Fight over Biogenerics Pathway

Senator Hatch Says Current Reverse Payment Bill Does Not Strike the Right Balance

Washington, DC, September 18, 2009 – The founders of the Hatch-Waxman Act, which created the modern generic drug industry, today told the Generic Pharmaceutical Association (GPhA) Annual Policy Conference that generics have saved the American health care system far more money than predicted, and praised the industry for the vital role it plays in bringing high quality, effective and affordable medicines to consumers. To ensure that greater access to generics is continued, both called for increased funding for FDA’s Office of Generic Drugs (OGD).

Senator Orrin G. Hatch, (R) Utah, emphasized that timely access to high quality generic drugs is “important, especially as we consider health care reform legislation.” He also noted that during these difficult economic times, generics play a critical role. He stated that the House funding did not go far enough and he supported the higher increase in the Senate legislation.

Chairman Henry A. Waxman (D) California, echoed Senator Hatch’s support for increased OGD funding stating that, “making sure consumers have access to generic drugs has been one of my chief goals in Congress.”

On reverse payments, Senator Hatch firmly stated that when he and Rep. Waxman created the Hatch-Waxman Act, it was critically important to allow generic companies to challenge patents to provide incentives to get to market early. He noted that the current bill pending in the Senate Judiciary Committee “doesn’t strike the right balance.” He went on to say that Congress has an obligation to consumers not to jeopardize a program that has saved significant money.

On the issue of biogenerics, Chairman Waxman issued a strong warning that the “war is not over” on biogenerics. He stated that the Eshoo amendment adopted by the Energy and Commerce Committee would “make a mockery of generic competition.” And if the amendment becomes law, Chairman Waxman said it would “impose almost insurmountable barriers to real competition in the biopharmaceutical marketplace… The Eshoo amendment is everything a monopolist could hope for.”

Chairman Waxman also noted that the Eshoo amendment would not only cause Americans to lose the opportunity for more affordable costs, it will also hurt innovation. Chairman Waxman stressed that it “sometimes takes a long time for a good idea to become accepted, but it eventually happens if we keep fighting.” He noted that the “legislative process is organic, ever changing, dynamic and that people rethink their views before becoming law.” He stressed that it was essential to keep fighting and that he “will be there every step of the way with you.”

“We were honored to have our industry’s founding fathers with us as we celebrate the 25th anniversary of the Hatch-Waxman Act,” said GPhA President and CEO Kathleen Jaeger. “We thank both Senator Hatch and Chairman Waxman for their long-standing commitment to increasing access to generic medicines. We particularly applaud Senator Hatch’s support for making reverse payments work for consumers.

“Furthermore, we strongly heed Chairman Waxman’s call that the war is not over in the fight for a workable biogenerics pathway. We remain committed to working with both Democratic and Republican members of Congress to ensure that biogenerics drive competition and get lifesaving medicines to patients sooner rather than later while also fostering innovation. We agree with Senator Hatch that it is critical to foster innovation -- there would not be a generic pharmaceutical industry if there were not a strong brand industry. However, we believe, as does President Obama, Chairman Waxman and more than 70 organizations representing seniors, consumers and businesses, that we can achieve a balance between competition and innovation without unprecedented and unnecessary years of market exclusivity.”

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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