The Association of Corporate Counsel (ACC) is the world's largest organization serving the professional and business interests of attorneys who practice in the legal departments of corporations, associations, nonprofits and other private-sector organizations around the globe.
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The Food and Drug Administration has long taken the position that while an off-label use of pharmaceuticals and medical devices is legal, off-label marketing or promotion is not legal. However, recent jurisprudence calls into question whether merely marketing a product for an off-label use is sufficient to satisfy the requirement of making a “false statement” under the False Claims Act (FCA). In this presentation, we will outline the elements of the FCA and the Anti-Kickback Statute (AKS), and discuss case law and agency guidance regarding whether off-label marketing or promotion truly puts healthcare companies at risk of violating the FCA and AKS.
The Federal Government and a number of prominent state governments have enacted, or proposed, legislation and other regulations aimed at regulating or curbing private equity investment in healthcare provider entities. Investors and providers should understand current and proposed limits on their ability to transact.
The Federal Government and a number of prominent state governments have enacted, or proposed, legislation and other regulations aimed at regulating or curbing private equity investment in healthcare provider entities. Investors and providers should understand current and proposed limits on their ability to transact.
During our meeting at noon on Tuesday, April 2nd, Ben Dryden from our Sponsor Foley & Lardner LLP, will offer a Legal Update on recent developments in antitrust in the healthcare sector. The Update will cover the Biden Administration’s most recent efforts to promote competition in healthcare; the recent reforms to the federal Merger Guidelines; notable enforcement updates; and trends on the horizon for healthcare companies for 2024 and beyond.
During our meeting at noon on Tuesday, April 2nd, Ben Dryden from our Sponsor Foley & Lardner LLP, will offer a Legal Update on recent developments in antitrust in the healthcare sector. The Update will cover the Biden Administration’s most recent efforts to promote competition in healthcare; the recent reforms to the federal Merger Guidelines; notable enforcement updates; and trends on the horizon for healthcare companies for 2024 and beyond.
This Legal Update will cover False Claims Act developments, including a discussion of the most pertinent recent cases, other developments, and DOJ’s False Claims Act recoveries and statistics from 2023.