Senate HELP Committee Passes Amendment for 12-Year Biologics Exclusivity Period

July 14, 2009

By Kurt R. Karst –      

Following the introduction of several proposals last week, as well as a proposal from Senator Sherrod Brown (D-OH), the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee voted 16-7 late Monday night in favor of a proposal offered by Sens. Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin Hatch (R-UT) to create a Follow-On Biologics (“FOB”) pathway that provides 12 years of exclusivity for pioneer biologics.  By a vote of 5 to 17, the committee rejected Sen. Brown’s proposal to provide 7 years of base exclusivity for pioneer biologics, according to various press reports (here, here, and here).  The HELP Committee reportedly did not vote on other competing FOB proposals that would have provided exclusivity periods shorter than 12 years.

The 12-year exclusivity proposal passed by the Committee, which is reportedly substantively identical to a bill passed by the HELP Committee in 2007 (S. 1695), is now part of a larger health reform measure that will eventually be voted on by the Committee and the full Senate.  The House of Representatives is still debating FOB legislation.  On July 14th, the House Judiciary Committee, Subcommittee on the Courts and Competition Policy is scheduled to hold a hearing on FOB legislation.  Representative Anna Eshoo, who introduced a bill (H.R. 1548) that would provide for up to 14.5 years of market exclusivity for a new biologic product, is scheduled to testify at the hearing. 

Categories: Hatch-Waxman