Many people in Philadelphia, New York City and parts of New Jersey have noticed billboards recently advertising Vivitrol — the message mainly being “What is Vivitrol?” with an 800 number to call. The billboards are on highways. “They’re everywhere,” several New York City dwellers told us. “Ads for Vivitrol are everywhere,” Charles Ornstein, senior reporter at ProPublica, tweeted on May 10. Many people don’t know what the drug does — blocks the effects of opioids — but they were intrigued by the ads anyway.
Asked about the campaign, Matthew Henson, spokesman for Alkermes, which makes Vivitrol, told us the company “recently launched a targeted campaign in select areas of metro New York, New Jersey and Pennsylvania to help generate more awareness of Vivitrol as a treatment option for the prevention of relapse to opioid dependence,” he said. “The opioid epidemic is the public health crisis of our time and we recognize that it’s important that patients and caregivers have a better understanding of all FDA-approved treatment options so that they can have an informed conversation with their physician,” he said. “Awareness of Vivitrol as a treatment option is still relatively low and we often hear from patients and caregivers that they want to know all of their options.”
But the ads don’t make product claims, such as calling Vivitrol a treatment option for the prevention of relapse. They just get the brand name out there. Alkermes, as the patent holder of Vivitrol (it expires in 2029), can invest in such advertising. Methadone and buprenorphine, both generic, can’t afford such advertising.
A year ago, when a similar blitz took place in Boston, there was great concern among the medical community, who said it would be better if patients were given a more general public service campaign about substance use disorders and the availability of all kinds of treatment.
Even the more extensive print ads we have seen do not give the most important information about the medication — extended-release naltrexone — that is used to treat opioid use disorders. This information is that the patient must be opioid-free for a week before the shot can be given. Otherwise, severe withdrawal, which is painful and life-threatening, could ensue. It seems like the kind of thing it would be important for consumers to know in what is called “direct-to-consumer advertising,” or DTCA as the term is known. So we asked the Food and Drug Administration (FDA), which is responsible for regulating prescription pharmaceutical advertising. It turns out that this responsibility only goes so far. First of all, unlike labeling, the advertising doesn’t have to be submitted to the FDA for approval first. “In most cases, federal law does not allow the FDA to require that drug companies submit ads for approval before the ads are used,” said Jeremy Kahn, trade press officer for the FDA. “We see many ads at about the same time the public sees them.” If the FDA thinks an ad violates the law, it sends the drug company a letter asking that the “ads be stopped right away,” said Kahn.
As for the Vivitrol ads in particular, “FDA does not comment on specific promotion for one product/company,” said Kahn.
“FDA encourages drug companies to use language that is clear and understandable to the general public,” he said.
The key is whether the ad makes a product claim. If it does, it must also tell at least one approved use for the drug, the generic name of the drug and “all the risks of using the drug,” said Kahn. This may be why the Vivitrol ads don’t make any claim, but simply give an 800 number to call or a website to go to. There, patients can get more information, and if they choose to, look up adverse effects.
“The problem with such ads is that the onus is eventually on the consumer to learn as much as needed about the medicine, including caveats about side effects or drug interactions,” Ed Silverman, senior writer at STAT News and Pharmalot columnist, told us last week. “Alerting consumers to the existence of a medicine is fine, but it’s not the whole story.”
For more information from the FDA on prescription advertising, go to https://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm076768.htm#control_advertisements.