Regulatory Focus™ > News Articles > FDA Promotional Enforcement Actions Hit Record Low in 2015

FDA Promotional Enforcement Actions Hit Record Low in 2015

Posted 19 January 2016 | By Michael Mezher 

FDA Promotional Enforcement Actions Hit Record Low in 2015

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a record-low nine letters to companies for advertising and promotion violations.

While OPDP has seen a general downward trend in issuing action letters in recent years, 2015 marks the first time the office has issued fewer than 10 letters in a single year.

In 2014, OPDP issued 11 letters, though it would later go on to retract one letter to Pacira Pharmaceuticals and lift one to AngioDynamics after the company closed out the issues.

FDA opdp

Of the nine letters sent in 2015, only two were warning letters, the remaining seven letters were untitled letters. Nearly half of the letters involved digital promotional materials, while the remaining five were for promotional materials on traditional media.

The most common citations in letters sent by OPDP in 2015 involved inadequate or omitted risk information and unsubstantiated or misleading statements.

FDA Office of Prescription Drug Promotion (OPDP) 2015 Citations
Lack of Adequate Directions for Use2
Minimization of Risk1
Omission of Risk Information4
Omission of Material Fact3
Misleading Claims2
Promotion of an Investigational Drug1
Unsubstantiated Superiority1
Unsubstantiated Claims2
Inadequate Communication of Indication1

One of the warning letters, sent to Duchesnay, Inc., involved Facebook and Instagram posts by Kim Kardashian, who was paid to act as a spokesperson for its morning sickness drug Diclegis.

In the posts, Kardashian praises Diclegis for improving her morning sickness, and tells women to talk to their doctors about taking the drug. However, the text of the post did not convey any risk information and instead linked to a website that presents risk information about Diclegis.

While FDA has been enforcing advertising and promotion on various social media platforms, the agency has yet to finalize its guidance on social media. To date the agency has issued four draft guidances that deal with social media:

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