FDA and DOJ investigating Galena Biopharma

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Last month, California-based company Galena Biopharma disclosed that the US Attorney’s Office for the District of New Jersey, along with the US Department of Justice (DOJ) are carrying out a criminal investigation in parallel to an already-existing civil investigation, concerning the marketing of Abstral (fentanyl), an opioid that the company sold for around $8 million back in 2015.

The disclosure came in an SEC filing, in which Galena stated that they were aware of the investigations but gave no further details:

“There 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.”

This disclosure follows on from the news that the company was in receipt of a subpoena from the New Jersey office just over a year ago, which demanded access to a range of documents relating to the marketing of Abstral. Subsequently, two physicians who were noted to be high prescribers of Abstral were the subject of a federal investigation in connection with a possible violation of a number of federal statutes, including the False Claims Act, and their trial got underway this month.

Galena’s filing revealed the existence of the subpoena and confirmed that the company had been contacted in connection with the criminal investigation:

“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.”

This disclosure by Galena comes as the FDA and DOJ intensify their efforts to stamp out bribes and illegal promotions associated with the prescribing of fentanyl-based medications, which have been associated with a rise in overdoses and fatalities.

In December, a number of pharmaceuticals executives, who had previously worked for Insys Therapeutics, were arrested in connection with a conspiracy to bribe medical practitioners and in June, several pharma company workers were arrested for their part in a fentanyl kickback scheme.

 

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