GPhA calls on Senate to include bipartisan biogenerics rule

Commenting on the Senate Committee on Health, Education, Labor & Pensions' markup of FDA reform legislation, GPhA president/CEO Kathleen Jaeger said that a broad group of organizations representing tens of thousands of Americans have united behind efforts to bring safe, effective, and affordable biogenerics to consumers. "Given this strong support and the real need for these medicines, Congress cannot afford to ignore this important issue." Jaeger remained optimistic that Senators will ultimately act in the best interests of patients and pass meaningful biogenerics legislation. "The Senate has the opportunity to do right by consumers when it considers FDA reform legislation on the floor in the coming weeks. Failure to include biogenerics in the FDA reform bill will be more than a missed opportunity; it will be a critical blow to patients who are demanding safe and affordable biogenerics." Jaeger declared that the Senate must enact a clear, efficient, and abbreviated approval pathway to ensure timely access to biogenerics. "A pathway that is filled with barriers and loopholes is a pathway in name only and will fail to deliver access."

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