FDA News Quotes Robert Huffman on DOJ’s New Guidance for FCA Prosecutions

FDA News has quoted Akin Gump government contracts partner Robert Huffman in the article “DOJ Offers Drugmakers ‘Get out of FCA Litigation Free’ Card.” The article reports that the Department of Justice is offering drug companies facing False Claims Act litigation a chance to walk away without steep fines, as long as they disclose the fraud, cooperate with investigators and fix any underlying problems.

According to the article, under the DOJ guidelines companies would still be liable for the government’s actual losses and would have to pay the costs of investigations and awards to whistleblowers. The new guidelines, however, ease the burden for drug companies that face hundreds of millions—if not billions—of dollars of risk in government fraud investigations.

Huffman said it is all part of a government policy examination over the past two-and-a-half years. In 2017, DOJ officials announced similar cooperation guidelines for the Foreign Corrupt Practices Act. At the end of last month, the department said that companies would also get credit for having built compliance programs in advance of the fraud.

Huffman said that’s huge for drug companies. “In the old days, the general approach was ‘Hey, if you’re here and there’s been misconduct by somebody in your employment, your compliance program can’t have been very good,’” he observed. “DOJ has come 180 degrees on that. Not maybe everybody in DOJ but the people who are calling the shots recognize that just because stuff happens doesn’t mean your compliance program is no good. The key is not whether stuff happens, it’s whether stuff keeps happening.”