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Valeant Pharmaceuticals says it has retained an expert to examine the finances of its specialty drugs business, which includes the dermatology brand Dermatologic Bioscience, as part of the U.S. Food and Drug Administration’s ongoing investigation into the company’s former generic drug chief executive, Mylan CEO Heather Bresch.
On Monday, Valeant said it has retained Dr. George P. Bush, a board-certified dermatologist and clinical professor at the University of Texas-Austin, to offer his expertise in evaluating the company’s finances.
Drs. Bush and John Cawley of the Harvard Medical School will also perform a clinical review of the market for dermatological products, Valeant said.
Valeant received an order from the FDA to evaluate the finances of the two pharmaceutical companies it acquired in April last year, including Dermatologic Bioscience, which is a specialty brand for the over-the-counter market. The FDA also wants to examine Valeant’s other generic drug unit, NanoEthix, which Valeant acquired in February.
The company says it has not yet received a formal determination from the FDA.
“We are reasonably certain that a definitive resolution of the matter will be determined soon,” Valeant said in a statement.
“We are ready and very enthusiastic about working with the FDA,” Marc J. Askin, Valeant’s general counsel and chief compliance officer, said in a phone interview. “Valeant is committed to good corporate citizenship, and we have been working for several months on our review with the FDA. We will do everything we can to cooperate with the FDA.”
Revealing Valeant’s investigation would be a signal of the FDA’s scrutiny of Valeant. The agency has been investigating whether Bresch approved certain generic drug applications of Valeant’s products, despite the company’s failure to comply with reporting requirements for patents.
Investigations by the FDA are usually conducted to determine whether companies have filed false and misleading statements and whether they have violated the agency’s regulations.
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