James S. Cohen, a shareholder in the Food and Drug Section of Buchanan Ingersoll & Rooney's Washington, D.C., office, was quoted in the cover story of today's issue of InsideHealthPolicy.com. The article, titled "FDA, CMS Plan New 'Pilot Program' to Stem Off-Label Marketing," discussed the program and the new administration's emphasis on agency collaboration.
As an industry source, Cohen was asked to weigh in on the program to detect pharmaceutical fraud and explained that "the short description of the program is consistent with FDA Commissioner Margaret Hamburg's new approach to enforcement."
He also noted that "there has been an increase of federal and state investigations in the off-label promotion area over the last year or two, both through qui tam lawsuits filed under the False Claims Act and through misbranding charges under the Food, Drug and Cosmetic Act -- as in the Eli Lilly case."
"There is a more comprehensive use of the available statutory and investigative resources," Cohen said, adding that he "expects off-label promotion to be a continued area of FDA and DOJ focus." He explained, "CMS’ interest in the program ties to its increased attention to the legitimacy of reimbursement payments in view of findings or convictions for off-label marketing."
Cohen said that the FDA has worked closely with CMS through its unapproved drugs initiative, and he expects the agencies will similarly coordinate to target off-label marketing.