Former Senate Leaders Support Follow-On Biologics Pathway, Comparative Effectiveness Research

Former Senator Majority Leaders Howard Baker, Tom Daschle, and Bob Dole released a report this month, Crossing Our Line: Working Together to Reform the US Health System, which proposes four pillars of health reform. The pillars are: (1) Promoting High-Quality, High-Value Care; (2) Making Health Insurance Available, Meaningful and Affordable; (3) Emphasizing and Supporting Personal Responsibility and Healthy Choices; and (4) Developing a Workable and Sustainable Approach to Health Care Financing. The report comes out of the Bipartisan Policy Center, a nonprofit organization established in 2007 by Baker, Daschle, Dole, and former Senator George Mitchell to provide a forum for discussing tough policy challenges.

Specific recommendations under Pillar 1 that may be of interest to the pharmaceutical industry include moving to electronic, patient-centered quality reporting, and expanding comparative effectiveness research (e.g., developing the infrastructure to compare treatment and practices, and prioritizing research topics). Pillar 4 recommendations are also noteworthy, including the suggestion to create an approval pathway for competing biologic products (i.e., follow-on biologics).

The report suggests that Congress create such a regulatory pathway in order to promote competition, and thus, save significant costs for individuals and for federal programs (specifically, $9 billion over 10 years, says the report). The authors specifically state their support for the bipartisan legislation in both the House and Senate on this matter, and suggest Congressional leaders “resolve policy differences” regarding exclusivity “in time to pass this legislation as a component of healthcare reform.”