Banishing the bleach

Key Points

"Hydroquinone remains the gold standard. That's why there's a lot of concern from dermatologists about it being removed from the marketplace," says Zoe Draelos, M.D., clinical associate professor of dermatology, Wake Forest University School of Medicine, Winston-Salem, N.C., and a member of Dermatology Times' editorial advisory board.

At press time the FDA was reviewing comments on the measure, according to spokeswoman Crystal Rice. However, she gave no indication when the agency would render its decision.

"They're widely used for both therapeutic indications and cosmetic concerns, and given the lack of an effective substitute, they should not be removed from the market," he says.

"If we give up hydroquinone, we're damn fools," says Albert M. Kligman, M.D., professor emeritus of dermatology, University of Pennsylvania.

Clearing the field

Should the proposed rule stand, only hydroquinone products with NDA clearance - at present, only Tri-Luma (hydroquinone, tretinoin, fluoucinolone acetonide; Galderma) - would remain on the market, doctors say.

"The ones that will disappear are the generics that did not submit applications to the FDA," along with OTC formulations, Dr. Draelos says.

Grandfathered in at the FDA's creation, "Generic formulations have never been proven safe and effective," she says. And because 2 percent OTC formulations aren't considered drugs, she adds, "None of those were looked at by the FDA."

Leaders in the OTC market include Esoterica (Medicis), Porcelana (DEP Corp.) and Ambi (Johnson & Johnson), Dr. Draelos says.