Monday, April 23, 2001
The DHEA Agendas
Wedge Against Dietary Supplements
Genelabs Techinologies Inc.'s efforts to test and market Aslera have been hindered by the ready availability of dietary supplements containing DHEA in U.S. health food stores and over the Internet. Ironically, this competition also may have propelled the company's application through FDA, convincing senior policy officials to overrule concerns from more junior staff about the robustness of GNLB's data. If GNLB's version of DHEA is approved, FDA probably would find it much easier to prohibit non-prescription sales of the steroid.
Last week's Arthritis Advisory Committee meeting was similar in some respects to a September 1997 advisory committee meeting on the use of Celgene Corp.'s version of thalidomide to treat skin lesions and fever associated with erythema nodusum leprosum. Senior agency officials pushed for approval, despite strong objections from FDA medical reviewers who argued that there was insufficient safety and efficacy data.