Alexandra Gorman

Alexandra Gorman

Skadden, Arps, Slate, Meagher & Flom LLP

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Latest Publications


"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

9/29/2015 - Advertising Amarin Caronia Commercial Speech Corporate Counsel Criminal Prosecution DOJ Enforcement Actions False Advertising FDA FDCA First Amendment Health Care Providers Labeling Medical Devices Misleading Impressions Off-Label Promotion Pharmaceutical Industry Popular Product Labels Ripeness Warning Letters

"Department of Justice Issues Guidance to Criminal and Civil Prosecutors to Facilitate Individual Prosecutions in Corporate...

On September 9, 2015, the Department of Justice (the Department) publicly announced that it had issued guidance to its criminal and civil prosecutors that purports to change, at least in part, the Department’s approach to...more

9/16/2015 - Civil Investigation Demand Civil Monetary Penalty Cooperation Agreement Corporate Crimes Corporate Investigations Criminal Prosecution DOJ False Claims Act (FCA) FIRREA Government Investigations Personal Liability White Collar Crimes Willful Misconduct Yates Memorandum

"U.S. v. Novartis: Reaffirming the Importance of Updating and Adhering to Corporate Policies"

A recent decision in a false claims act case, United States ex rel. Bilotta v. Novartis Pharmaceuticals Corporation (Novartis), underscores the importance of policing employee adherence to corporate policies and industry...more

11/18/2014 - Anti-Kickback Statute Chief Compliance Officers False Claims Act (FCA) Health Care Providers Novartis Pharmaceutical Industry Popular Risk Management

"Is the DOJ FCPA Enforcement Hegemony Dead?"

For nearly 15 years, the United States has had the worldwide corruption enforcement stage to itself, reaping billions of dollars in fines and settlement payments from companies that have acknowledged engaging in bribery in...more

6/27/2014 - DOJ Enforcement FCPA International Banks UK UK Bribery Act World Bank

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