Senators seek mandatory drug study database

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Drug and medical device companies would be required to report clinical trial results in a public database under legislation unveiled on Monday by a top U.S. Senate Republican and three Democrats.

The push for disclosure of all clinical trials follows criticism last year that some companies hid studies that were unfavorable to their products.

The new bill would create an electronic database with information about study outcomes and funding, potential drug side effects, and demographic information on test subjects.

"Increased transparency and openness can lead to greater accountability and, ultimately, safer drugs and increased consumer confidence,” said Senate Finance Committee Chairman Charles Grassley, an Iowa Republican and one of the bill’s authors.

Companies that refuse to comply with the study reporting requirements would be subject to penalties of up to $10,000 per day.

Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), said the industry group was just starting to review the bill.

He noted that drug makers set up a database last year for companies to voluntarily report summaries of clinical trial results, and PhRMA has encouraged members to list studies in a government database at http://ClinicalTrials.gov.

Drug companies have been working since 2001 “to make sure patients and their doctors receive meaningful clinical trial information,” Trewhitt said.

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