Saturday, December 7, 2013

Another Must Read Slide from the Conference!!

Hot Topics in Enforcement: Lessons Learned (Part I)
Bottomley Case – Lessons Learned in the Application of the Sentencing Guidelines and its Effect on Food and Medical Product StakeholdersUsing the Bottomley case as one example, this panel will discuss the penalties for counterfeit, unapproved, and mislabeled medical products. Beginning to a review of FDASIA, the Title 7 revisions, and sentencing guidelines, the panelists will then focus on specific enforcement actions and actions in the off-label context. The panel will wrap up with a brief commentary on what to expect next.

Joshua M. Davis, Partner, Arnold & Porter LLP | Slides
John Roth, Director, Office of Criminal Investigation, FDA

Note:   Amendment could increase penalties for conduct that has nothing
directly to with fraud and/or health care services
– e.g., cGMPs, refusing to produce records during an FDA inspection

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