Drugs

31 New Drug Fraud Investigations in 2016: Report

The FY 2016 Health Care Fraud and Abuse Control (HCFAC) Program report issued by HHS and the Justice Department says that the FDA Prescription Fraud Program (PFP) operated by the agency’s Office of Criminal Investigations with funding from HCFAC opened 31 criminal investigations in the fiscal year, including:

two investigations involving allegations of questionable manufacturing practices of foreign-based drug firms;
two investigations involving allegations of questionable manufacturing practices of an injectable drug by a domestic manufacturer causing the finished product to be super-potent;
three investigations involving allegations of questionable manufacturing practices of drugs and medical devices ultimately causing public safety risks through misbranding and/or adulteration;
one investigation involving marketing schemes by medical device and drug manufacturers;
20 investigations involving allegations of clinical trial fraud; and
three investigations involving allegations of application fraud.

The report notes that the types of criminal investigations conducted through the PFP tend to be complex and require several years to reach completion. In 4/2016, it says, an investigation that was opened in 2014 resulted in a clinical trial coordinator being arrested and charged with falsifying documents within multiple clinical trials. Also, in 7/2016, the majority owner of a compounding pharmacy that infected 750 people with mold and resulted in 64 deaths pled guilty along with her husband. Additional defendants are scheduled for trial early this year.

“FDA believes that various investigations initiated under the PFP show promise of future judicial action that may include criminal prosecution and monetary recoveries,” the report says. “These promising cases include several large foreign drug manufacturers under investigation for data integrity and other manufacturing violations which would deem their products adulterated and could possibly pose a risk to the public health and safety.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome