The June 13 markup date for a Senate bill that would allow FDA to approve generic versions of biotechnology drugs has been pushed back a week, according to a spokesperson for Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.), CongressDaily reports (Edney, CongressDaily, 6/7). The bill (S 623) was introduced earlier this year by Sens. Charles Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.).
It would allow FDA to approve "comparable" and "interchangeable" generic versions of biotech medications through an "abbreviated" process. The legislation would not specifically require companies that seek to market generic biotech medications to conduct clinical trials, but it would allow FDA to require trials on a case-by-case basis (Kaiser Daily Health Policy Report, 4/13). Sources say that the markup of the generic biotech bill was delayed by the immigration debate in the Senate (CongressDaily, 6/7).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Publication Date: 2007-06-10 10:00
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