Lawmakers Introduce Legislation for Clinical Trials Registry

As expected, Sens. Chuck Grassley (R-Iowa) and Christopher Dodd (D-Conn.) have introduced legislation that would create an electronic clinical trials registry to which drugmakers must submit the results of their drug studies or face monetary penalties.

The new version of the Fair Access to Clinical Trials (FACT) Act aims to ensure access to clinical trial data by the scientific community and the general public, the senators said. Dodd had introduced the bill last session, and recently garnered the support of Grassley, chairman of the Senate Finance Committee and a leading Republican advocate for improving drug safety.

Recent revelations that patients might have been harmed by the suppression of data from drug studies underscore the necessity for public assess to basic information about research studies on healthcare products and drugs, the senators said in a statement. "Increased transparency and openness can lead to greater accountability and, ultimately, safer drugs and increased consumer confidence," Grassley said.

Under the FACT Act, drug sponsors would be required to report research outcomes, basic demographic information on subjects, funding sources, significant adverse events and the product's FDA approval status, among other information. The bill also establishes strong enforcement mechanisms, including monetary penalties of up to $10,000 a day for manufacturers who refuse to comply. Results of clinical trials would be maintained through the NIH's ClincalTrials.gov website.