A May 18 Health article on Sculptra, an injectable filler for facial wrinkles, quoted a dermatologist who is a member of a Food and Drug Administration expert panel as saying that manufacturer Dermik Laboratories had recommended the product for non-approved uses. The company strongly denies it has engaged in or plans to engage in off-label marketing of Sculptra. (Published 5/19/04)
Independent advisers to the Food and Drug Administration (FDA) recently recommended quick-track approval of Sculptra (poly-L-lactic acid), an injectable, long-lasting facial wrinkle filler, after maker Dermik Laboratories pleaded urgent need. Was it really? Or was it, as one FDA adviser suggested, Dermik's "really cunning regulatory strategy" for a product used in other countries to treat age-related wrinkles? You be the judge.
The Pitch Dermik's petition said the product is only for treating facial lipoatrophy, a sinking of the cheeks common among HIV patients. But the firm plans to begin product tests on a more general population later this year, said Dermik spokesman Rob Partridge.
The Catch The drug can't be marketed to that wider audience without FDA review, a process that normally takes years. But off-label use is inevitable once the product is approved for HIV patients, according to several FDA independent advisers. Dermatologist Amy Newburger, a member of the FDA's general and plastic surgery devices panel, said a Dermik sales rep has already pitched the product to her as a wrinkle buster.
Is It Safe? "There is no other material that we have ever seen presented that has had such a paucity of data, true data," said Newburger during the March 25 hearing, according to an official transcript. Testing was limited to a small, nonrandomized sample. Fellow panelist Michael Miller voiced concern that 10 years from now another hearing would question "why did we let this go through without understanding more about it."
-- Rita Zeidner