GPhA lauds Governors' action

August 14, 2006

The Generic Pharmaceutical Association (GPhA) praised four of the nation's Governors for filing a citizen petition with the FDA seeking immediate release of agency guidance that would pave the way for the introduction of more affordable generic versions of insulin and human growth hormone (HGH). The citizen petition was filed by Govs. Kathleen Sebelius (D, Kan.), Tim Pawlenty (R, Minn.), James H. Douglas (R, Vt.), and Jim Doyle (D, Wis.).

GPhA lauds Governors' action

The Generic Pharmaceutical Association (GPhA) praised four of the nation's Governors for filing a citizen petition with the FDA seeking immediate release of agency guidance that would pave the way for the introduction of more affordable generic versions of insulin and human growth hormone (HGH). The citizen petition was filed by Govs. Kathleen Sebelius (D, Kan.), Tim Pawlenty (R, Minn.), James H. Douglas (R, Vt.), and Jim Doyle (D, Wis.). Kathleen Jaeger, president/CEO of GPhA, commented that the Governors have correctly noted that biopharmaceuticals place an extreme burden on state healthcare budgets, one that could be lowered significantly if an efficient and effective mechanism existed for the development and approval of generic biopharmaceutical products. "The time has come to open the floodgates for generic competition on these and other products," she said. According to the citizen petition, American patients spend approximately $1.5 billion on insulin products to treat diabetes and approximately $433 million on HGH, which is used to treat a variety of conditions, including growth deficiencies in children and adults, chronic renal insufficiency, and AIDS wasting syndrome. Market competition for insulin and increased market competition for HGH products could save the American healthcare system hundreds of millions of dollars annually.

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