Abstract

AIDS: Eleven principles, primarily to get treatments to patients faster or to avoid changing the Food and Drug Administration (FDA) in ways people do not want, are presented as ways for reforming the FDA. The introduction and summary of a consensus statement, written by five AIDS activists, are also provided. The statement addresses avoiding unnecessary delays and streamlining the process of getting new treatments to people faster. The draft covers the following: improving compassionate access, accelerating approval refinements, Institutional Review Board approval of phase I academic research, creating an appeals process, and providing information about off-label drug use. Finally, four reforms, suggested by Jim Driscoll of the Log Cabin Republicans, are outlined. More information can be obtained on Log Cabin Republican regulatory reform efforts by calling Jim Driscoll at (415)552-0269.