Rosen Quoted in Law360

10 May 2013 Law360 News


Partner David L. Rosen was quoted in a May 10, 2013 Law360 article titled, “Drug Cos. See Path to Legal Off-Label Marketing.” The piece discusses the drug industry’s efforts to push the FDA to support “truthful off-label marketing,” which has the potential to significantly boost the sale of pharmaceuticals. Rosen was quoted as saying, “The sale of products for uses that go beyond the scope of the approved labeled indications is huge. ... Companies have paid significant fines for seeking government reimbursement for products sold for off-label uses.” Rosen believes that drug makers are extremely interested in additional information on what the FDA expects of them when it comes to off-label marketing. "We start seeing a little bit of activity by FDA in enforcement, and everybody jumps to a lot of conclusions," Rosen said. "But those enforcement actions are extremely fact-specific. We're not well-served if we base our decisions on what to do in these areas on one isolated piece of FDA enforcement."