Senate Clinical Trials Registry Bill Gains Support Of Finance Chairman
This article was originally published in The Pink Sheet Daily
Executive Summary
Sen. Grassley (R-Iowa) joins Sen. Dodd (D-Conn.) in reintroducing a bill requiring registry of clinical trials in a public database. Grassley says he will introduce a bill in March setting up an independent drug safety office at FDA.
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A Senate bill that would establish a database of the results of all publicly and privately funded clinical trials is being reintroduced with the support of Finance Committee Chairman Charles Grassley (R-Iowa). The "Fair Access to Clinical Trials Act" was introduced by Sens. Grassley and Chris Dodd (D-Conn.) Feb. 28. It is similar to the FACT Act introduced by Dodd in October. One change to the bill is a provision requiring FDA to "make internal drug approval and safety reviews publicly available," Grassley said in a statement on the Senate floor. The bill would maintain the National Library of Medicine's ClinicalTrials.gov website as a registry of ongoing trials for serious or life-threatening diseases, but would also establish a database of all clinical trials for drugs, biologics and medical devices. Trials would have to be registered in the database to obtain approval from a U.S. institutional review board. Foreign trials submitted to FDA or used in advertising would also have to be registered in the database. The bill also follows standards and recommendations made by outside organizations. "The bill's standards will meet all of the minimum criteria for a trial registry set out by the International Committee of Medical Journal Editors" in September, Grassley said (1 (Also see "Medical Journals To Require Registration Of All Controlled Trials On ClinicalTrials.gov" - Pink Sheet, 8 Sep, 2004.)). In addition, the bill mandates that the results of trials be made publicly available, which "satisfies the recommendation of the American Medical Association," Grassley said. Civil monetary penalties for trial sponsors that fail to comply are retained in the new version of the bill. Grassley said he intends to introduce legislation establishing an independent office of drug safety within FDA in March. The senator indicated his interest in forming a new safety review office at a November hearing on Merck's withdrawal of Vioxx (2 (Also see "Sen. Grassley Wants "Independent" Drug Safety Function In FDA" - Pink Sheet, 18 Nov, 2004.)). - Scott Steinke |