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.”
People
Related News
August 8, 2025
In the News
Gregory Husisian and David Simon Uncover the High Stakes of Tariff Evasion
Foley & Lardner LLP partners Gregory Husisian and David Simon are featured for their insights on how the U.S. government is cracking down on tariff evaders in the Newsweek article, "America Is Making Billions From Catching 'Tariff Cheaters.'"
August 7, 2025
In the News
Kyle Faget Weighs in on Trump Pharma Tariffs
Foley & Lardner LLP partner Kyle Faget assessed the Trump administration's implementation of import tariffs on the pharmaceutical industry in the Pharma Life Sciences article, "Trump's pharma import tariffs threaten drug pricing, generics."
August 5, 2025
In the News
Aaron Maguregui on Health Data Sharing Plan – 'I would expect the FTC to be heavily involved'
Foley & Lardner LLP partner Aaron Maguregui addressed a new health care data sharing initiative announced by the federal government in the Bloomberg Law article, "Digital Data-Sharing Plan Tests Limits of Health Privacy Rules."