The FDA's promotional watchdog served up its most serious ad violation to Alkermes Wednesday—and it took the unusual step of announcing that violation to the world.
The Office of Prescription Drug Promotion cited Alkermes in a warning letter for omitting safety risks from an ad touting the anti-addiction treatment Vivitrol. In that letter, the agency said it had contacted the company twice before issuing the warning.
The FDA also made an extra, and atypical, move by issuing a press release that announced the "serious" violations.
“Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner," OPDP director Thomas Abrams said in the announcement. "This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”
It's not the first time Alkermes has drawn fire for its marketing efforts, including lobbying for broader use of Vivitrol. A media outcry that began in 2016 eventually prompted Sen. Kamala Harris to launch an investigation into the company's Vivitrol promotions.
At issue now is an ad that did not include prescribing information highlighting Vivitrol patients' vulnerability to opioid overdose, the letter said. After Vivitrol treatment, patients face the danger of life-threatening opioid intoxication if they use opioids again, because the addiction drug can essentially reset medication tolerance to a lower level.
The FDA is also asking Alkermes to come up with a plan to create new “corrective messages” to counter the ad.
The warning letter mentions two other times the FDA had reached out to Alkermes, so the more serious warning letter—versus the more commonly doled out untitled letter—may be a result of the FDA's dissatisfaction with those responses.
After noting those two previous contacts, the letter says the “OPDP is concerned that Alkermes continues to promote Vivitrol in a manner that fails to adequately present this important risk information in a truthful and non-misleading manner."
For Alkermes' part, it released a statement saying the promotion at issue was a journal advertisement that it's no longer using. It also seems to take issue with the warning itself, noting that the information the FDA requests was included in the ad, albeit in the brief summary instead of the ad itself.
“In the Warning Letter, the FDA states that certain of the important safety information contained in the Brief Summary should have been in the body of the Journal Advertisement itself," the statement reads. "We are currently finalizing our response to the FDA Warning Letter in accordance with FDA’s requested timeline."
Alkermes has faced criticism for its marketing practices—and even bolder lobbying efforts—aimed at building name recognition and driving sales of Vivitrol, first approved for alcohol addiction in 2006 and then for opioid addiction in 2010.
The media backlash began two years ago, after Tom Price, then-Health and Human Services Secretary, mentioned Vivitrol by name as a potential treatment for opioid addiction. Vivitrol is a branded once-monthly injectable version of the off-patent addiction drug naltrexone. It costs about $1,000 per shot, while generic naltrexone pills are far cheaper.
Headlines followed from The New York Times and were echoed in additional original reporting from NPR, ProPublica, Yahoo and smaller local newspapers and TV stations. The news outlets highlighted Alkermes’ lobbying and marketing efforts—outdoor awareness ad campaigns have run from Ohio to Massachusetts.
The ads showed the “profit opportunities that drug companies and investors see in an opioid epidemic," according to the NYT—or, as NPR put it, that some drugmakers are trying “to cash in on the opioid epidemic."
Later that year, Sen. Kamala Harris D-Calif. announced an investigation into Alkermes’ Vivitrol marketing.
At the time, Alkermes disputed the media portrayal and said it had no intention of stopping its marketing efforts.
“Vivitrol is an important and distinctive medication that has been used by tens of thousands of patients," Alkermes asserted in a statement then. "Unfortunately, recent statements in the press have criticized Vivitrol and our company. We believe that the opinions published in these articles are dangerous in the midst of an unyielding epidemic where very few patients are being treated to begin with.”
Vivitrol sales totaled $303 million in 2018 and are projected to reach $330 million to $340 million this year.