Ahead of today’s Senate committee hearing on legislation to enable the US Food and Drug Administration to back generic versions of biologic drugs, Democrat Senator Edward Kennedy has suggested that requirements for approval should follow the cautious European model.
“We have a responsibility to expand the horizons of medical science in every responsible way possible so people can live longer and fuller lives. Our goal in legislation should be to enable companies to invest in new medical breakthroughs while doing all we can to cut costs for patients and protect safety,” said Sen Kennedy, who chairs the Senate Health, Education, Labor and Pensions (HELP) Committee which will conduct the hearing.
Meantime, members of the Coalition for a Competitive Pharmaceutical Market have been in Washington lobbying for legislation to allow an approval pathway for biogenerics and counter the arguments of biotechnology companies that they might not be as effective as the original branded versions and could also pose safety problems.
The Coalition, which includes large national employers including General Motors, plus health plans, pharmacy benefit managers, pharmacies and generic drug manufacturers, supports the bipartisan Access to Life-Saving Medicines Act of 2007 as “a safe, science-based approach that appropriately leaves full discretion to the FDA to determine the safety and efficacy of biogenerics,” says the group’s chair, Annette Guarisco.
– Former FDA Commissioner Mark McClellan has said recently that he has always believed that it is “an issue of when, not if, and it may well be this year” that Congress passes legislation to create a clear, efficient abbreviated approval pathway for biogenerics. By Lynne Taylor