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OIG’s annual Work Plan targets drug pricing and data protection issues

USA - November 10 2015 The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has released its Work Plan for fiscal year 2016. The items...

William A. Sarraille, James C. Stansel, Brenna E. Jenny.

FDA proposal to drop knowledge prong of “intended use” rules grants long-standing industry request, with significant implications for off-label cases

USA - September 29 2015 On September 25, 2015, the Food and Drug Administration (FDA) published in the Federal Register a proposal to amend its existing “intended use”...

Coleen Klasmeier, Andrew R. Van Haute.

The DOJ’s new focus on individual accountability: implications for life sciences companies

USA - September 15 2015 On September 9, 2015, Deputy Attorney General Sally Yates released a memo (Yates memo) outlining several changes the Department of Justice (DOJ) will...

Brenna E. Jenny.

District Court holds that First Amendment bars prosecution for misbranding where conduct is truthful, non-misleading speech about off-label uses, declines to rule on potential FCA liability

USA - August 10 2015 On August 7, in the first Caronia progeny case, the United States District Court for the Southern District of New York (Engelmayer, J.) granted...

Coleen Klasmeier, Jaime L.M. Jones, Brenna E. Jenny.

FDA loses Amarin litigation; court grants preliminary relief

USA - August 10 2015 In a widely anticipated ruling on Friday, in the ongoing Amarin litigation against the United States Food and Drug Administration (FDA), Judge...

Coleen Klasmeier.