STATES PRESS FDA TO ACT ON GENERIC BIOPHARMACEUTICALS

The governors of 4 states are bringing pressureon the FDA to immediately release agencyguidance designed to speed the introduction ofmore affordable generic versions of insulin andhuman growth hormone (HGH).

A citizen petition was filed with the FDA byGovs Kathleen Sebelius (D, Kan), Tim Pawlenty(R, Minn), James H. Douglas (R, Vt), and JimDoyle (D, Wis). The 4 state leaders called on federaldrug regulators to provide the generic drugindustry with the regulatory guidance necessaryto introduce generic versions of those biopharmaceuticals.

Each year, Americans spend approximately$1.5 billion on insulin products to treatdiabetes, plus another $433 million on HGH.The governors said that these expenditurescould be reduced by hundreds of millions ofdollars annually through the introduction ofgeneric versions.

Their petition drew strong support from representativesof the Generic PharmaceuticalAssociation (GPhA). They described both insulinand HGH as "older, simpler, well-understood"biopharmaceuticals that should be available topatients as lower-cost generics. According tothe GPhA officials, regulatory "paralysis" at theFDA has held up efforts to market generic versionsof these products for years.

"The governors have correctly noted thatbiopharmaceutical products place an extremeburden on state health care budgets, one thatcould significantly be lowered if an efficient andeffective mechanism existed for the developmentand approval of generic biopharmaceuticalproducts," said Kathleen Jaeger, presidentand chief executive officer of GPhA. "The timehas come to open the floodgates for genericcompetition on these and other products."