Waxman And Hatch Foresee Follow-on Biologics Bill Regaining Momentum – In 2009
This article was originally published in The Pink Sheet Daily
Executive Summary
Closing window for congressional action, lack of House consensus and Sen. Kennedy’s absence among reasons the issue will be held until next year, they suggest.
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Look for a follow-on biologics bill to emerge from Congress in 2009 or 2010, Sen. Orrin Hatch, R-Utah, and Rep. Henry Waxman, D-Calif., advised participants in separate presentations July 14 at the Biotech and Pharmaceutical Public Policy Congress, convened by the Center for Business Intelligence in Arlington, Va. Legislation to create an approval mechanism for follow-on biologics has seen little concrete progress in several months. The Senate Health, Education, Labor and Pensions Committee agreed to FOB legislation, S.1695, in summer 2007, but did not officially report the bill out of committee. Hatch said he would like to see the panel complete action before the August congressional recess. But the absence of Chairman Ted Kennedy, D-Mass., who is receiving treatment for cancer, makes this difficult as he is one of the few Democrats who could give it the final push through the committee and the full Senate, Hatch said. And even if the Senate completes work on its measure, he pointed out, several bills have been introduced in the House, and no consensus approach has emerged from the House Energy and Commerce Committee. This also makes it "difficult to get a bill this year," Hatch said, though in the next Congress, "if we roll up our sleeves, we can get a bill that does not endanger innovation." Because "there is so little time left" in the current legislative session, Waxman agreed that the effort will be left to the next Congress. A final bill enacted by Congress will likely gain presidential support, regardless whether Sen. Barack Obama, D-Ill., or Sen John McCain, R-Ariz., wins his bid for the presidency, Waxman predicted. The House panel has been reviewing stakeholder responses to a six-page questionnaire on biologics legislation. Still, some major areas of disagreement remain, with one being data exclusivity. Both S. 1695 and a measure from Reps. Anna Eshoo, D-Calif., and Joe Barton, R-Texas, provide a minimum 12 years of data exclusivity for the innovator product. Waxman's proposal, H.R. 1038, provides none, and he indicated little interest in moving from that position. So far the biopharmaceutical industry has failed to justify its need for a data exclusivity period, he said, noting that biologics have a higher price tag than other drugs and that they already benefit from patent restoration under the Hatch/Waxman law for generic drugs. Follow-on biologics were recently, albeit briefly, back in the spotlight on Capitol Hill with the release of Congressional Budget Office scoring of S. 1695. CBO projects the bill could save $5.9 billion over 10 years (1 (Also see "Follow-on Biologics Get Modest Savings Score From CBO, Giving Legislation No Push" - Pink Sheet, 25 Jun, 2008.)). But those savings apparently are not enough to spark quick action on the languishing issue. While Hatch noted the report, neither he nor Waxman offered any suggestion that it might catalyze debate. -Cathy Dombrowski ([email protected]) |