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Washington, DC—A prominent Republican senator is adding his support to a proposed law that would require pharmaceutical companies and device manufacturers to register trials and post clinical results in a public database.
Washington, DC-A prominent Republican senator is adding his support to a proposed law that would require pharmaceutical companies and device manufacturers to register trials and post clinical results in a public database.
Sen. Chuck Grassley (R-IA), chairman of the Senate Finance Committee, reportedly plans to introduce legislation early this year that would mandate the registry. He joins four Democratic senators-Edward Kennedy (MA), Christopher Dodd (CT), Tim Johnson (SD), and Ron Wyden (OR)-who introduced a similar bill in October. A companion bill, sponsored by Rep. Edward Markey (D-MA), was introduced Oct. 7 in the House and was referred to the Subcommittee on Health.
Sen. Grassley's support indicates the first bipartisan support for the measure. His interest in the bill is linked to a hearing he led into the FDA's oversight of rofecoxib (Vioxx). Merck was forced to withdraw the popular arthritis drug from the market after evidence surfaced that patients in clinical trials had an increased risk of heart attacks and strokes.
Sen. Grassley's press aide did not return a phone call seeking comment.
The clinical trial registry is supported by numerous consumer advocacy groups, including the Consumers Union, Consumer Federation of America, the U.S. Public Interest Research Group, and the American Medical Association.
In addition, the Pharmaceutical Research and Manufacturers of America (PhRMA) has expanded its voluntary disclosure policy and its member companies have pledged to reveal publicly clinical trial information for diseases or conditions that are not life-threatening. Beginning July 1, PhRMA member companies will post, on a voluntary basis, information about all new mid-to-late stage trials as well. All ongoing hypothesis-testing trials are to be posted by Sept. 13.
The consumer groups claim the move by PhRMA is insufficient because it is voluntary and lacks an enforcement mechanism.
The measure concerns AMO Inc. Chief Executive Officer Jim Mazzo, who worries that such a registry could inhibit the development of medical devices. While he said he supports the idea of making trial information more public, he said medical devices are tested differently from pharmaceuticals and frequently are re-engineered throughout the trial process-something that would be difficult under some versions of the bill.
"Overall we support arming patients with all the relevant information," said Mazzo, who is working with AdvaMed, the Advanced Medical Technology Association, to alter the legislation's wording. "In the current way it's stated, it's not appropriate for medical devices."