By Donald Zuhn --
On the same day that BIO CEO Jim Greenwood was briefing the media regarding follow-on biologics legislation in the current Congress, the National Coalition on Health Care (NCHC) was making its position on the legislation known in a letter sent to Senate Committee on Health, Education, Labor, and Pensions (HELP) Chairman Senator Ted Kennedy and the Committee's ranking member, Senator Michael Enzi (R-WY). The NCHC, which was founded in 1990, describes itself as a non-profit and "rigorously non-partisan" coalition comprised of more than 70 organizations, employing or representing about 150 million Americans, that are working together to improve America's health care.
In its letter, the NCHC notes that biologics are among the most expensive and most important drugs available to patients today, accounting for 25% of all new drug products approved by the FDA and costing on average 22 times more than small molecule drugs. Stating that "[n]ow, there is an opportunity to yield substantial savings to the health care system by creating a generic pathway for high quality biologics as part of comprehensive health care reform," the Coalition encourages the Senate Health Committee to enact the Senate version (S. 726) of the bill introduced by Rep. Henry Waxman (H.R. 1427). The NCHC bases its endorsement of S. 726 on the "tremendous success" of the Hatch-Waxman Act, which the Coalition contends has "accelerated" innovation of brand drugs, "as demonstrated by a dramatic increase in research and development spending." (Amgen Inc. Vice President Stuart Watt would likely disagree with the Coalition's assessment of the impact of Hatch-Waxman, which he asserted earlier this year had resulted in less innovation, pharma company consolidation, and a shift in investment from pharma companies to biotech companies; see "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation").
Not surprisingly, the NCHC letter focuses on the issue of exclusivity for innovator biologics. Noting that "[s]ome of the bills that have been introduced would provide that innovator biologics would be entitled to 12-14 years of exclusivity [i.e., the Eschoo bill, H.R. 1548]," the Coalition "urge[s the Committee] to oppose generic biologics legislation that contains excessive periods of exclusivity or that contains other unnecessary and significant barriers to generic, biologic competition." In support of its plea to the Committee to reject double-digit exclusivity, the NCHC cites to the recent FTC report on biosimilars (see "No One Seems Happy with Follow-on Biologics According to the FTC"). The NCHC letter concludes that "[t]he five year period of exclusivity provided in H.R. 1427 follows the Hatch-Waxman model and is the appropriate period of exclusivity," and suggests that "[a]n unnecessarily long period of exclusivity would . . . diminish the incentives for other companies to continue innovating, actually resulting in less innovation over time."
Patent Docs thanks a reader for alerting us to the NCHC letter.
In its letter, the NCHC notes that biologics are among the most expensive and most important drugs available to patients today, accounting for 25% of all new drug products approved by the FDA and costing on average 22 times more than small molecule drugs. Stating that "[n]ow, there is an opportunity to yield substantial savings to the health care system by creating a generic pathway for high quality biologics as part of comprehensive health care reform," the Coalition encourages the Senate Health Committee to enact the Senate version (S. 726) of the bill introduced by Rep. Henry Waxman (H.R. 1427). The NCHC bases its endorsement of S. 726 on the "tremendous success" of the Hatch-Waxman Act, which the Coalition contends has "accelerated" innovation of brand drugs, "as demonstrated by a dramatic increase in research and development spending." (Amgen Inc. Vice President Stuart Watt would likely disagree with the Coalition's assessment of the impact of Hatch-Waxman, which he asserted earlier this year had resulted in less innovation, pharma company consolidation, and a shift in investment from pharma companies to biotech companies; see "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation").
Not surprisingly, the NCHC letter focuses on the issue of exclusivity for innovator biologics. Noting that "[s]ome of the bills that have been introduced would provide that innovator biologics would be entitled to 12-14 years of exclusivity [i.e., the Eschoo bill, H.R. 1548]," the Coalition "urge[s the Committee] to oppose generic biologics legislation that contains excessive periods of exclusivity or that contains other unnecessary and significant barriers to generic, biologic competition." In support of its plea to the Committee to reject double-digit exclusivity, the NCHC cites to the recent FTC report on biosimilars (see "No One Seems Happy with Follow-on Biologics According to the FTC"). The NCHC letter concludes that "[t]he five year period of exclusivity provided in H.R. 1427 follows the Hatch-Waxman model and is the appropriate period of exclusivity," and suggests that "[a]n unnecessarily long period of exclusivity would . . . diminish the incentives for other companies to continue innovating, actually resulting in less innovation over time."
Patent Docs thanks a reader for alerting us to the NCHC letter.
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