OPDP Issues First Enforcement Letter of 2017

A direct-to-consumer television ad for CONTRAVE (naltrexone HCI and bupropion HCI) made false or misleading statements about the risks of the product, according to the first 2017 Untitled Letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) to Orexigen Therapeutics Inc. on May 18.

The enforcement letter states that the ad, submitted to the agency under Form FDA 2253, is misleading because it includes efficacy claims for Contrave (which is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in obese or overweight adults) but fails to include important risk information for “a number of serious risks,” including a boxed warning on the package insert (PI), multiple contraindications and other warnings and precautions, as well as an indicator on the PI of the most common adverse reactions.

“The TV ad is misleading because it includes efficacy claims for Contrave, but fails to include important risk information associated with the drug,” OPDP states in the letter. “For example, the TV ad includes the statement ‘Do not take with opioids,’ but fails to include any of the other conditions for which Contrave is contraindicated. Additionally, the TV ad includes the statement, ‘Contrave may increase suicidal thoughts or actions in some children, teens and young adults within the first few months,’ but fails to disclose any information about neuropsychiatric reactions also discussed in the BOXED WARNING section of the PI.”

Although the company includes the statements “Contrave is not for everyone” and “Other side effects may occur,” these statements do not mitigate the omission of these important risks from the TV ad, according to OPDP, because omitting these risks “misleadingly suggests that Contrave is safer than has been demonstrated.”

OPDP also takes issue with the visual portion of the ad, because it communicates important risk information as SUPERs only, and with the audio of the ad presenting unrelated risk information in competing audio messages.

“The overall effect of disclosing important risk information in SUPERs only, along with the simultaneous presentation of SUPERs and competing audio messages, undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Contrave,” the letter states. “The presentation of the video is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”

Although the letter to Orexigen is only the first enforcement letter of 2017, OPDP had only issued two enforcement letters as of this date in 2016, part of an overall trend in recent years of far fewer advertising and promotion enforcement letters annually.