Please refer to #msg-20694180 for a description of the Kennedy-Clinton-Enzi-Hatch bill (“K-C-E-H”), which is currently moving through the U.S. Senate.
Q1: What is your expectation for biogenerics legislation during 2007?
a) No biogenerics bill will be enacted into law during 2007. b) A bill will be enacted into law in 2007 in substantially the same form as K-C-E-H. c) A bill will be enacted into law in 2007 that will be substantially different from K-C-E-H.
Q2 (To be answered only by those who selected answer “c” to Q1 above): The main distinction between K-C-E-H and the bill to be enacted is:
a) The enacted bill will confer less than 12 years of marketing exclusivity for branded biologic drugs. b) The enacted bill will not allow substitutability of a generic for a branded biologic drug. c) Some other difference.