The DHEA agendas

The unusual way senior FDA officials handled last week's advisory committee meeting on Genelabs Technologies Inc.'s Aslera prasterone DHEA suggests that the agency is looking for ways to approve the NDA to treat women with systemic lupus erythematosus. To do so, the agency will have to stretch its approval criteria, and do so in a way that doesn't set a precedent for diluting its requirements for robust scientific data.

FDA has a variety of motives for smoothing the path for Aslera (GL701), not the least the desire to make a new therapy available for a debilitating disease for which no new therapies have been approved for decades. But of perhaps equal importance is an interest in using Aslera as a weapon in the agency's battle to regain control over the marketing of dietary supplements. DHEA is available as a nutraceutical (see "Wedge Against Dietary Supplements," A4)...