Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel

Emily M. Leongini

Emily M. Leongini
Associate
Washington, DC
202.350.3649

Emily Leongini is an associate in Arent Fox's FDA Practice.

 

Blog Posts by Emily M. Leongini

Pharmaceutical & Device Compliance
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How FDA’s Program Alignment Initiative Will Impact Industries: An Insider’s Perspective

In his first major announcement since taking office, FDA Commissioner Scott Gottlieb, M.D. finalized a major reorganization plan that had been under development since 2013. The reorganization, termed “Program Alignment,” reassigns field staff based on product type rather than geographic regions. Under the new organizational model, inspection and compliance staff in FDA’s Office of Regulatory Affairs will specialize in the five commodities and two enforcement areas:

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Cannabis Industry Standards: ASTM Considers Filling the Void
Responding to requests from the cannabis industry, ASTM International, one of the world’s largest voluntary standards-developing organizations, recently announced that it may develop industry standards that would apply to “the full life cycle of cannabis” and consumable cannabis products. The standards could cover cannabis cultivation, sampling, testing, quality management systems, processing, handling, and labeling. 
 

Lack of Uniform Standards May Impact Consumer and Environmental Health

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False Claims Act
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Recent Drug Company Settlement Highlights Unique Theory of False Claims Act Liability: Failure to Follow Current Good Manufacturing Practices

Last month, Baxter International Inc. and Baxter Healthcare Corporation (collectively “Baxter”) settled a qui tam False Claims Act (FCA) case with the Department of Justice (DOJ) for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability. The government alleged that Baxter submitted false claims for a drug sold to the Department of Veterans Affairs and Department of Defense, as well as reimbursed by the Medicare and Medicaid programs, because the drug was “adulterated,” given Baxter’s alleged violations of the Federal Food, Drug, and Cosmetic Act’s (FDCA) current good manufacturing practice (cGMP) requirements – but not because of any impact on the drug itself.

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