A New Weapon To Help FDA Control Enforcement Priorities

By Peter Leininger (February 21, 2018, 3:04 PM EST) -- The world of False Claims Act investigations got a little more interesting last month. At the end of January, an internal U.S. Department of Justice memorandum suggesting that the DOJ might increase its efforts to dismiss meritless qui tams surfaced in the media. Many have applauded the sentiments expressed in the memo, particularly throughout industries that have been plagued by FCA cases. But the memo isn't just good news for industry. It also gives federal agencies that have been reluctantly swept into the explosion of FCA investigations a new way to rid themselves of dead-end whistleblower cases. And there is no agency that will welcome this tool more than the United States Food and Drug Administration. The FDA is currently struggling to navigate difficult constitutional issues in the realm of off-label promotion, which has been the subject of endless FCA investigations. This memo may be just what FDA needs to corral the whistleblower bar....

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