Sen. Chuck Grassley To Introduce Bill To Require Public Database of Clinical Trial Results

Sen. Chuck Grassley (R-Iowa) plans to introduce legislation in early 2005 that would require pharmaceutical companies to register drug trials and report findings in a public database, a Grassley aide said Thursday, the New York Times reports. According to the aide, who spoke on condition of anonymity, work on the bill was ongoing and it likely would be introduced "early in the next Congress."

The Times reports that the legislation is expected to include some features from recent proposals by Democrats, including a requirement that makers of drugs and medical devices register all trials involving human subjects in a government database before the trials could proceed. Test results would be reported in the same database.

According to the Times, Grassley's support might "be a significant advance" for the mandatory database issue "because it signals some bipartisan support." In addition, the aide said that Grassley would introduce separate legislation to create an independent office to oversee drug safety within FDA.

Some academic medical researchers say that registration of clinical trials before they begin would prevent companies from withholding negative results or ending such trials before their completion. Some academic researchers also say that a database would provide useful information on the effectiveness of new drugs.

However, the Pharmaceutical Research and Manufacturers of America said a mandatory government database is unnecessary. PhRMA has started its own Web site where companies can post trial findings, but the site does not require companies to register the trials at their inception. Under pressure to release information, a number of drug makers have begun posting trial results and related data on company Web sites (Meier, New York Times, 12/10).