FDA Advertising and Promotion Enforcement Activities: Update

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

In May, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following letter on FDA’s website:

• Untitled letter to Orexigen Therapeutics, Inc. re: NDA 200063 CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets (May 18, 2017) (“Contrave Untitled Letter”)

This is the first enforcement letter OPDP has posted in 2017, continuing a trend of declining enforcement activity from the office. Covington discussed that trend in a previous alert.

The Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) and FDA’s Office of Compliance and Biologics Quality (OCBQ) did not post any enforcement letters relating to advertising and promotion on FDA’s website in May (or previously in 2017).

This alert merely summarizes the allegations contained in FDA’s letter. It does not contain any analysis, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients