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Regulatory Focus™ > News Articles > FDA, DOJ Investigate Galena Biopharma’s Former Promotions of Fentanyl

FDA, DOJ Investigate Galena Biopharma’s Former Promotions of Fentanyl

Posted 09 January 2017 | By Zachary Brennan 

FDA, DOJ Investigate Galena Biopharma’s Former Promotions of Fentanyl

Galena Biopharma on Monday disclosed in an SEC filing that the US Attorney’s Office for the District of New Jersey and the US Department of Justice (DOJ) are pursuing a criminal investigation, in addition to a previously announced civil investigation, related to the marketing and promotion of its deadly opioid Abstral (fentanyl), which the company sold for $8 million upfront in 2015.

The details of the criminal investigation have not been disclosed.

“There also have been federal and state investigations of a company that has a product that competes with Abstral in the same therapeutic class, and we have learned that the FDA and other governmental agencies are investigating our Abstral promotion practices,” Galena said in its filing.

This announcement follows the company’s receipt of a subpoena issued by the New Jersey office in December 2015, requesting the production of a broad range of documents pertaining to the marketing and promotion of Abstral.

And this was followed by a federal investigation of two high-prescribing physicians for Abstral, which later resulted in the criminal prosecution of the two physicians for alleged violations of the federal False Claims Act and other federal statutes. The criminal trial began on 4 January 2017.

“We have received a trial subpoena for documents in connection with that investigation and we have been in contact with the U.S. Attorney’s Office for the Southern District of Alabama, which is handling the criminal trial, and are cooperating in the production of documents,” Galena added.

The news from Galena comes as DOJ has been cracking down on illegal promotions and bribes linked to the prescribing of fentanyl-based pain medications, which are contributing to a growing number of overdoses and fatalities.

In December, several pharmaceutical executives and managers, formerly employed by Insys Therapeutics, were arrested on charges that they led a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud health insurers. 

In June, former pharmaceutical company employees were also arrested for participating in a fentanyl kickback scheme.


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