FDA Memo Reiterates Off-Label Enforcement Policy
Pre-Trump agency memo on manufacturer communications about unapproved uses says new court rulings and studies on off-label uses and adverse reactions support restrictions; whether agency’s new leadership has the same view remains to be seen.
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US FDA Chief Counsel Rebecca Wood discussed ongoing reforms to FDA’s free speech enforcement approach and other enforcement priorities at a recent conference.
The US Department of Justice recently announced the largest-ever civil settlement in a device-related False Claims Act case. But otherwise it was a textbook FCA case, attorneys say, and many device companies still have a lot of work to do to ensure compliance and that their executives stay out of trouble. This is the first article in an occasional series in which Medtech Insight talks to attorneys to get the best takes on hot legal topics.
Two draft guidance documents would allow a broader range of communications with payers and others about information not included on device labeling, or concerning products without FDA approval.