By Kevin E. Noonan --
As reported today in The Wall Street Journal, the innovator biotechnology industry scored a major victory in the Senate on Monday, when that chamber's Health, Education, Labor and Pensions Committee approved an amendment providing a 12-year data exclusivity period for biologic drug makers.
The committee voted 16-7 in favor of a proposal put forth by Senators Orrin Hatch (R-UT; at left), Michael Enzi (R-WY; below right) and Kay Hagan (D-NC), and rejected Senator Sherrod Brown's (D-OH) amendment for a 5-year data exclusivity term. In doing so, the committee also rejected the Federal Trade Commission's rationale that data exclusivity (and, indeed, any sort of regulatory protection) is unnecessary for biologic drugs.
While The Journal also noted that the ultimate fate of the 12-year data exclusivity period is uncertain in view of White House support for a seven-year period and the political pressures brought to bear by groups like the AARP, it should also be remembered that the 12-year term is shorter than at least come estimates of the average time required for biologics drug developers to recoup development costs. It is also shorter than the period proposed by Senator Kennedy last week (although his proposal may have acted as a "placeholder" for the Hatch/Enzi proposal). A 12-year data exclusivity term was one of the areas of consensus during debate last year on biosimilar legislation before Congressman Waxman's current bill (H.R. 1427) reduced the proposed term to 5 years.
The Journal reports that these provisions are intended to be a part of the healthcare system overhaul bill expected to be voted out of committee today. Importantly for the debate, Senators Hatch and Enzi argued persuasively that a shorter exclusivity period would "stifle innovation and put U.S. companies at a disadvantage to international competitors," an argument that may resonate with others in the current economic climate.
For additional information regarding this and other related topics, please see:
• "NVCA Study Supports 12-Year Data Exclusivity Period," July 13, 2009
• "NCHC Sends Letter on Biosimilars to Senate Health Committee," July 9, 2009
• "Senator Kennedy Weighs in on Biosimilar Data Exclusivity Period," July 9, 2009
• "BIO CEO Provides Update on Follow-on Biologics Legislation," July 8, 2009
• "Follow-on Biologics in the News - No. 4," June 29, 2009
• "White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics," June 26, 2009
• "AEI Believes Advantages of Longer Data Exclusivity Period Outweigh Disadvantages," June 18, 2009
• "No One Seems Happy with Follow-on Biologics According to the FTC," June 14, 2009
• "Follow-on Biologics in the News - No. 3," April 27, 2009
• "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation," April 22, 2009
• "Former House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is Sufficient," November 20, 2008
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