Chris Dodd: “To anyone offering to flyspeck this proposal and offer variations to it, I would say that months and months have gone…”

“To anyone offering to flyspeck this proposal and offer variations to it, I would say that months and months have gone into this legislation which we think has had the dual effect of ensuring that the ramifications of expanding the length of exclusivity, as some have proposed, have been carefully considered along with proposals to limit the length of exclusivity to 3 months for all drugs, as others have proposed. The bill before us balances many viewpoints on this program and is a proposal that 15 major organizations involved with the effort strongly support. Throughout the 10-year history of the Best Pharmaceuticals for Children Act, Congress has recognized the need to ensure it strikes the appropriate balance between the cost to consumers and benefits to children. By instituting a 5-year sunset in both the original legislation in 1997 and the first reauthorization in 2002, Congress was acknowledging the ongoing need to evaluate the cost of the incentive under this act to consumers in relation to the benefit of having medications properly studied and labeled for children. The 6-month incentive of exclusivity has been very successful in generating pediatric studies. Yet after 10 years, experience and data have shown us that for a small number of drugs, pediatric exclusivity has far exceeded the carrot that was designed to encourage people to move forward.”