Monday, July 2, 2001
A non-approvable letter issued by the FDA last week for Genelabs Technologies Inc.'s Aslera prasterone DHEA to treat systemic lupus erythematosus (SLE) doesn't mean that patients won't have access to DHEA. Even if the agency doesn't view Aslera's efficacy as sufficient to warrant approval as a drug, the hormone remains available over the counter in the U.S. as a dietary supplement, and some clinicians already recommend DHEA to their lupus patients.
The decision reflects FDA's quandary over dietary supplements and nutraceuticals, over which it has only limited regulatory oversight: if companies try and fail to prove their efficacy as drugs, they still remain on the market. But if FDA were to approve them - which would ensure cGMP manufacture and at least guarantee that each dose contained the same amount of active product - the agency would render its standards for efficacy meaningless.