Bill Introduced in Senate To Require Disclosure of Clinical Trial Results on Electronic Public Database
Pharmaceutical and medical device companies would be required to report the results of all clinical trials on a public, electronic database under legislation introduced Monday by Senate Finance Committee Chair Chuck Grassley (R-Iowa) and three Democratic legislators, Reuters/New York Times reports. The bill calls for the creation of a database that would include information about clinical trial outcomes, funding, potential drug side effects and participants' demographic information (Reuters/New York Times, 3/1).
Under current law, pharmaceutical companies must post data on a government Web site only for trials that involve treatments for life-threatening diseases or conditions. Drug companies must inform FDA of all clinical trials performed in the United States, but they only have to make public the date if the trials are part of an FDA application for approval (California Healthline, 1/10).
Grassley said, "Increased transparence and openness can lead to greater accountability, and, ultimately, safer drugs and increased consumer confidence."
Pharmaceutical Research and Manufacturers of America representatives were unavailable to comment on the bill (Reuters, 2/28).
WAMU's "The Diane Rehm Show" on Tuesday is scheduled to include an interview with Grassley in the first hour of the program about several issues, including FDA's drug safety monitoring (Rehm, "The Diane Rehm Show," WAMU, 3/1). The complete segment will be available online in RealPlayer and Windows Media after the broadcast.