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Staff Changes at the FDA’s Office of Regulatory Affairs: New Regulators and…
On September 3, 2013, FDA Commissioner Margaret Hamburg, M.D. announced in an email to FDA staffers that Melinda Plaisier would…
Oregon Physicians Fined for Not Disclosing Relationships with Industry to…
A new development coming out of Oregon is likely to play a critical role as stakeholders begin tracking and reporting payments to…
Summary of Recent Settlements Novartis, Amgen and Boehringer Ingelheim
The healthcare fraud settlements just keep rolling in. Recently, federal healthcare enforcement authorities settled several cases…
Medicare Advantage Plans Reviewing Options for Pharmaceutical Lawsuits
In a related case reported in mid-April of this year, Bloomberg News reported that the U.S. Supreme Court left intact a ruling…
States Becoming More Aggressive Prosecuting Off Label Promotion
For the last several years, we have reported extensively about the government settlements, investigations, and prosecutions of…
HHS-OIG: Podcast on Improper Payments
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) offers a wide array of resources…
Proactive Planning for HHS-OIG-DOJ Investigations
Over the last four years, the U.S. Department of Justice (DOJ) along with the U.S. Department Health and Human Services (HHS) has…
US Court of Appeals Rules that Off Label Promotion May Be Treated as…
Earlier this month, as reported by Reuters, the U.S. Court of Appeals for the First Circuit issued an opinion that may allow…
Court Upholds InterMune Executive Conviction on Misleading Speech
In December of last year, we reported on a landmark ruling from the United States Court of Appeals for the Second Circuit (New…
Caronia and How Settlements May Not Be So Good for Public Health
In a detailed article about the Caronia decision, Scott Gottlieb, MD, a resident fellow at the American Enterprise Institute (AEI)…