FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

DoJ Increases Focus on Compounders, Supplement Makers

Dec. 16, 2015

Illegal conduct in the compounding and dietary supplement industries are two of the Department of Justice’s top three areas of increased focus, a deputy assistant attorney general said last week.

“In 2012, we learned about the potential harm that could be caused by unsafe compounding products,” said Jonathan Olin, deputy assistant attorney general within the DoJ’s Civil Division, referring to GMP violations at the New England Compounding Center that led to 64 deaths due to meningitis.

“As we seek to hold accountable those responsible for that incident, the DoJ and FDA remain committed to preventing future harm from unsafe compounded drugs,” he added, noting that two people were charged with murder and 12 others with serious crimes.

Those trials are set for next year, Olin said during his keynote address at the Food and Drug Law Institute’s Enforcement, Litigation and Compliance conference in Washington, D.C.

Illegal activity in the dietary supplement industry also is drawing the DoJ’s scorn, as far too often “we have seen supplement makers lie about what their products can do, what’s in them or both,” Olin said.

A few weeks ago, the DoJ, FDA, U.S. Postal Service, Federal Trade Commission, Department of Defense and U.S. Department of Agriculture announced the completion of a year-long sweep that resulted in the filing of more than 100 criminal and civil actions against unlawful supplement makers.

Among those indicted was supplement maker USPlabs, which was charged with conspiracy to import ingredients from China using fake certificates of analysis and false labeling, Olin said. He said the company knew that studies linked the ingredients to liver toxicity, and that after promising the FDA it would stop distribution, the company then tried to sell as much product as quickly as it could.

To stop these practices, the DoJ is increasing its focus on companies and individuals that make false claims or commit fraud, Olin warned, as evidenced by the $96 million in fines the DoJ collected from the pharmaceutical industry in FY 2015.