Congress last week approved legislation (HR 3580) that aims to provide the public with better and quicker access to data on drug safety and drug development, Technology Daily reports.
The measure, which was debated by lawmakers for two-and-a-half years, was passed by a 405-7 vote in the House on Wednesday and by a voice vote in the Senate on Thursday (Sternstein, Technology Daily, 9/21). President Bush is expected to sign the measure, the AP/Houston Chronicle reports (Bridges, AP/Houston Chronicle, 9/21).
The compromise legislation calls for FDA Web sites to make more drug reviews publicly available and would create a public, online registry of clinical drug trials and their results. The information is aimed at helping patients, providers and researchers make better health care decisions, Technology Daily reports.
The legislation does not include a provision by Sen. Byron Dorgon (D-N.D.) that would have allowed individuals and pharmacies to import FDA-approved prescription drugs from FDA-registered foreign manufacturers. The proposal would have created a Web site listing the contact information of registered importers approved by FDA.
Scott Wallace, president and CEO of the National Alliance for Health IT, said, "The bill isn't, in and of itself, a total solution to the problems of information access by consumers, but it is a step." He added, "We are hopeful that the increased resources available under this bill will allow the agency to move more quickly into the electronic communications era" (Technology Daily, 9/21).