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FDA’s Rx Promo Citations Rise Slightly In 2016; Investigational Drug Promos Scrutinized

 
• By Brenda Sandburg

Office of Prescription Drug Promotion seemed to expand its focus in issuing 11 letters last year.

2016-2017 Biopharma in Perspective

For much of 2016, FDA seemed on pace to issue a record-low number of citations for Rx advertising, but in an end-of-year flurry, the agency issued six enforcement letters, bringing the tally to 11 – two more than the agency’s Office of Prescription Drug Promotion issued in 2015. That figure was a record low, which FDA retroactively matched for 2014 when it withdrew a letter to Pacira Pharmaceuticals Inc. regarding the promotion of Exparel (bupivacaine liposome injectable suspension).

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