Leaders on the Senate Health, Education, Labor and Pensions Committee have re-introduced a bill to require drugmakers and the Food and Drug Administration to engage in better safety planning before releasing drugs to the public, and to improve the FDAs response to risks identified after a drug is on the market.
One of the key provisions of the bill is to establish a publicly available database of clinical trials to help enhance patient enrollment in drug trials, and provide a mechanism to track subsequent progress of trials. In addition, the bill would establish a database to ensure that the results of clinical trials are made public. Sen. Edward Kennedy (D-Mass.), the committees chairman, and ranking member Sen. Mike Enzi (R-Wyo.) hope to report the bill after Easter to get it considered on the Senate floor by late spring, and then conference with the House to get it approved before the August recess, according to a statement from Enzis office. -- by Jennifer Lubell