Senate Finance Considering Clinical Trials Registry Legislation
This article was originally published in The Pink Sheet Daily
Executive Summary
Senate Finance Committee Chair Chuck Grassley (R-Iowa) is planning a bill to establish a clinical trial registry
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Senate Finance Committee Chair Chuck Grassley (R-Iowa) is planning a bill to establish a clinical trial registry. Grassley is "looking at legislation to establish a clinical trial registry for drug companies to make more information available to the public regarding pharmaceutical drugs on the market," the senator's office said Dec. 9. The effort was announced along with a request that Pfizer and FDA provide documentation of safety-related labeling changes for Bextra (see 1 (Also see "Sen. Grassley Asks FDA, Pfizer To Detail Bextra Labeling Changes" - Pink Sheet, 10 Dec, 2004.) ). Grassley has already announced plans to develop legislation to establish an independent drug safety office at FDA (2 (Also see "Sen. Grassley Plans Legislation On Independence Of FDA Drug Safety Office" - Pink Sheet, 23 Nov, 2004.)). Congressional Democrats introduced the "Fair Access to Clinical Trials Act" in October to mandate registration of all clinical trials for drugs, biologics and medical devices on the National Library of Medicine's ClinicalTrials.gov website in order to obtain institutional review board approval. NLM maintains that ClinicalTrials.gov is the appropriate place to list all initiated clinical studies (3 (Also see "ClinicalTrials.gov Is "Right Place" To List Initiated Trials, NIH Agrees" - Pink Sheet, 21 Sep, 2004.)). - Elizabeth Walker |