STATES PRESS FDA TO ACT ON GENERIC BIOPHARMACEUTICALS

SEPTEMBER 01, 2006

The governors of 4 states are bringing pressure on the FDA to immediately release agency guidance designed to speed the introduction of more affordable generic versions of insulin and human growth hormone (HGH).

A citizen petition was filed with the FDA by Govs Kathleen Sebelius (D, Kan), Tim Pawlenty (R, Minn), James H. Douglas (R, Vt), and Jim Doyle (D, Wis). The 4 state leaders called on federal drug regulators to provide the generic drug industry with the regulatory guidance necessary to introduce generic versions of those biopharmaceuticals.

Each year, Americans spend approximately $1.5 billion on insulin products to treat diabetes, plus another $433 million on HGH. The governors said that these expenditures could be reduced by hundreds of millions of dollars annually through the introduction of generic versions.

Their petition drew strong support from representatives of the Generic Pharmaceutical Association (GPhA). They described both insulin and HGH as "older, simpler, well-understood" biopharmaceuticals that should be available to patients as lower-cost generics. According to the GPhA officials, regulatory "paralysis" at the FDA has held up efforts to market generic versions of these products for years.

"The governors have correctly noted that biopharmaceutical products place an extreme burden on state health care budgets, one that could significantly be lowered if an efficient and effective mechanism existed for the development and approval of generic biopharmaceutical products," said Kathleen Jaeger, president and chief executive officer of GPhA. "The time has come to open the floodgates for generic competition on these and other products."




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