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Amendment passes that will create greater transparency in drug safety advisory panels

September 28, 2005

Amendment passes that will create greater transparency in drug safety advisory panels
The legislation, sponsored by Sen. Richard Durbin of Illinois, requires that the FDA post the names of scientific advisers who are granted waivers for their conflicts on its Website at least 15 days before an advisory committee meeting. It also requires that the FDA simultaneously publish the nature of those conflicts on its website.

Currently, the public has to file a freedom of information request to get the names of the companies involved and the amounts paid to those scientists for consulting, speaking, doing studies and the like. Anyone who has ever filed a FOIA request with FDA (or most other agencies in this administration) knows that the process can take years.

There is one final element to the Senate bill. The FDA will have to document its efforts to find unconflicted scientists every time they create a new advisory panel. While this in itself doesn’t change anything, it creates an incentive for the agency to at least try to find unconflicted scientists since the alternative is to file blank reports.