It’s no Kardashian kerfuffle, but the FDA's ad police have sent their first letter of the year. The untitled letter sent to Collegium Pharmaceuticals tackles a hot-topic category, opioids, over a misleading booth at a pharmacists’ convention.
The Office of Prescription Drug Promotion (OPDP) sent the letter over advertising for Collegium's branded oxycodone drug, Xtampza ER. The problem? The exhibit booth failed to “adequately communicate” risk information, OPDP said.
The offense occurred last year in June at the meeting of the American Society Health-System Pharmacists in Minneapolis. An OPDP representative on site spotted the issue.
Collegium's Xtampza was already on OPDP’s radar. As OPDP noted in the February warning, it had communicated advice to Collegium earlier regarding Xtampza when the drugmaker submitted its draft presentations. In September 2016, OPDP said it gave advisory comments that recommended Collegium make revisions on what it had submitted.
“In particular, we cautioned Collegium about failing to present risk information for Xtampza ER with a prominence and readability reasonably comparable to the presentation of benefits. We are concerned that Collegium is promoting Xtampza ER in a manner that fails to adequately present the very serious risks of the drug, despite this direction from OPDP,” the letter noted.
Eye on FDA blogger and public relations professional Mark Senak noted in a blog post last week that the letter is significant for two reasons. He said it shows that OPDP is still actively enforcing policies, despite a very low number of letters sent in 2017. The move also sends a message to drugmakers in the opioid category—already under heavy fire from government agencies as well as consumers—that they should probably carefully review promotions, especially when it comes to risk, he said.
OPDP sent five letters in 2017, which was the lowest in its history, although more typical of recent years. OPDP did send more in 2016, with a total of 11, but overall numbers have been on the decline since 1998, when it sent a whopping 156.
In 2015, for instance, the OPDP sent just nine letters to pharma companies for marketing violations, down from 10 in 2014.