IRVINGTON, NY (
chief executive Joseph Gulfo is throwing the regulatory equivalent of a tempter tantrum directed at U.S. regulators for not approving the company's skin cancer detection device.
A Citizen Petition filed with the U.S. Food and Drug Administration accuses the agency of not following its own regulations in the review of Mela's MelaFind device, the company said in a statement Monday.
"Mela Sciences is asking the Commissioner to investigate why her Agency has acted outside its own laws, regulations and guidelines, as described at length in the Citizen Petition," said Mela CEO Joseph Gulfo, referring to FDA commissioner Margaret Hamburg.
over strenuous objections from FDA reviewers who made it clear that the risk of misdiagnosis of skin cancer was too high to approve MelaFind in its current form. During the panel, FDA demanded Mela conduct another clinical trial prior to considering MelaFind's approval.
Since the panel,
Mela amended the MelaFind approval application
to restrict the device's use to trained dermatologists, hoping that would assuage regulators' concerns. The company has sought a face-to-face meeting with FDA officials to discuss the MelaFind review but regulators are ignoring the company, Mela said.
"We're inviting the commissioner to shine a light on the
MelaFind review, to bring transparency to it," said Gulfo, on a conference call. "The silence
from FDA is deafening," he added.
Gulfo accuses FDA of violating a "binding protocol agreement" signed between the company and agency that the company claims dictated the clinical trials needed to review and approve MelaFind. FDA, in its review of MelaFind, said the clinical trial conducted by Mela didn't meet FDA's approval standards.
Under the rules of the Citizen Petition, the FDA is required to respond within 180 days, which in this caes means early November. The Citizen Petition, however, cannot force FDA to approve MelaFind and Mela hasn't conducted any new studies or generated new clinical data to further support its argument for why FDA should approve the skin cancer detection device.
MELAFind is a computer-enhanced imaging device that takes high-tech pictures of suspect moles and lesions to assist doctors in the early detection of melanoma, the deadliest form of skin cancer.
Mela shares were up 10 cents to $3.46 in early Monday trading.
--Written by Adam Feuerstein in Boston.
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