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Focus on Regulation

Hot Topics at FDLI Enforcement, Litigation and Compliance Conference

Topics discussed at the recent Food & Drug Law Institute’s (FDLI) Enforcement, Litigation and Compliance Conference included FDA Center leaders’ enforcement priorities, interagency enforcement actions, the implications of increasing globalization, and the diversion of controlled substances.  Among the highlights:

  • Joseph Rannazzisi, Deputy Assistant Administrator in DEA’s Office of Diversion Control, said due diligence is the key for distributors meeting their obligations to design and operate systems to disclose suspicious orders of controlled substances.  He made particular mention of on-site visits.
  • Michael Blume, Director of DOJ’s Consumer Protection Branch, spoke about the increase in cases involving manufacturing compliance as well as device defect reporting.
  • Mary Malarkey, Director of CBER’s Office of Compliance and Biologics Quality, talked about recent enforcement actions involving doctors using experimental stem cell and placental tissue procedures, and efforts to stop distribution of unapproved HIV testing kits.
  • Several government speakers emphasized the need for global partnering among regulatory agencies, such as collaborative inspections and sharing inspection reports.  FDA has already relied on foreign agencies’ findings to prohibit imports.