Both House and Senate FDA reform bills require that drug trials are publicly registered, but the House bill would require a public technical trial results database, as well a lay summary of a drug trials, on the Internet. The Senate bill only calls for a study on how to create such a results registry, and gives the FDA 2-1/2 years to make it happen. A final version of the Food and Drug Administration Revitalization Act is being negotiated.
The White House position - official or unofficial - is in line, as it so happens, with PhRMA's position. And there is one problem with this view - failing to make trial results public would allow drugmakers to hide safety problems. Drugmakers may be worried that results can be misinterpreted, but after several years filled with controversies over safety data - antidepressants, Vioxx, Avandia, Ketek, Trasylol, to name a few - industry brought the congressional push for a public database on itself.
â€œIf this is truly the administrationâ€™s position, itâ€™s shocking,â€ said Bill Vaughan, senior health policy analyst with Consumers Union. â€œAt a time when parents canâ€™t even trust their kidsâ€™ toys to be safe, it doesnâ€™t make sense the White House would oppose legislation to help make prescription drugs safer.â€
"White House opposition to this aspect of the FDA reform bill is in line with its general approach to open government, which is to say, it opposes it," writes Merrill Goozner in GoozNews, adding that the NIH's Library of Medicine database links to scores of articles not yet validated by peer review. "But disclosure of clinical trial results data is crucial if independent researchers are going to be able to conduct meta-analyses of problematic drugs."