It’s taken five months, but the FDA has finally issued its first untitled letter of the year for promotional infractions. The agency's watchdogs scolded Orexigen Therapeutics for alleged infractions in a TV commercial for weight loss drug Contrave.
In the letter, the Office of Prescription Drug Promotion says the television ad misleads viewers by touting Contrave's benefits and downplaying its risks. For instance, the letter says the spot omits important risk information—including potential neuropsychiatric reactions, such as suicidal thoughts, that are highlighted in a black-box label warning (PDF).
“By omitting serious risks associated with Contrave, the TV ad misleadingly suggests that Contrave is safer than has been demonstrated,” the letter notes.
The ODPD also criticized the way the ad presented important risk information—as superimposed copy only—and said the audio portion of the TV ad only presents unrelated information on the drug's risks. The overall effect “undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Contrave,” according to the ODPD.
Peter Flynn, Orexigen’s senior VP, global head of development, regulatory affairs and safety, said in a statement to FiercePharma that Orexigen is currently addressing the OPDP guidance,
“We are confident we will be able to resolve the presentation of safety information in the TV advertisement in a timely manner and respond to OPDP by the requested date of June 2,” he said.
The Contrave TV ad has been running since December, and Orexigen has spent more than $36 million on national TV ad buys since then, according to data from realtime TV ad tracker iSpot.tv.
Mark Senak, a public relations professional and the author of Eye on FDA blog, noted the lack of overall ODPD enforcement this year in a column about the Contrave untitled letter.
Senak questioned the overall downturn in enforcement. “Does the issuance of a letter after a five-month silence indicate a renewed effort at enforcement following the change in leadership at FDA?” he asked.
He did note that the OPDP said previously there are other forms of enforcement besides handing out letters. However, he said, the lack of transparency doesn’t shed any light on what those actions might be.