GPHA OBJECTS TO LANGUAGE IN BIOSHIELD LEGISLATION

Generic drug industry representatives are continuing their assault on several provisions in recently proposed biodefense legislation, including a definition of "countermeasure" that could include virtually all marketed drugs.

"The term countermeasure [in the legislation] is overly broad," said Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association (GPhA), during a recent briefing on BioShield in Washington, D.C., sponsored by the Coalition for a Competitive Pharmaceutical Market. "Almost any product in your medicine cabinet would be deemed a countermeasure."

Building on provisions in last year's Project BioShield Act, which was signed into law last summer, Sens. Joseph Lieberman (D-Conn.), Orrin Hatch (R-Utah) and Sam Brownback (R-Kan.) this spring unveiled the Project BioShield II Act of 2005. The new legislation, introduced April 28, authorizes additional reforms, including tax incentives and intellectual property protections, to motivate the pharmaceutical industry to develop bioterrorism countermeasures.

GPhA remains opposed to the legislation's definition of countermeasure because it doesn't specify that the product must be used for the primary effects of a bioterrorist attack, nor does it require that the product be a new chemical entity, Jaeger said.