Expert: Innovator Biologic Makers May Be Hurt by Kennedy’s Death

Innovator biologic makers that sought a 10- to 12-year data exclusivity period may have to rebuild support in the Senate following the death of Sen. Edward Kennedy (D-Mass.) and the forthcoming change in leadership of the Senate Health, Education, Labor and Pensions Committee (HELP), an expert says. “The bill that he wanted was a reasonable one that probably would have gotten support from PhRMA and maybe even from the generic firms,” Jack Calfee, an American Enterprise Institute economist who studies the drug industry and the FDA, said. Kennedy was a key supporter of the Affordable Health Choices Act passed by the Senate HELP Committee, which would give innovator biologics 12 years of data protection.
Washington Drug Letter