Pharma taking liberties with DTC ads, says study
Drugmakers face guardrails governing marketing their products in TV ads, including a bar on teasing indications not approved by the FDA — but a new study finds pharma companies may be bending the rules.
The study, published in the Journal of General Internal Medicine earlier this month, found no ads examined described all medication risks "quantitatively," and very few were compliant with Food and Drug Administration guidelines.
The authors concluded that the quality of information was generally "very poor" among the 151 DTC ads studied, of which 97 were for unique products. Only 67 of these advertised unique drug-indication relationships since many drugs have separate ad campaigns for distinct indications.
Thirteen percent of the ads — all of which were for drugs to treat diabetes — improperly communicated some type of benefit of the drug that was not included in the original claims, a practice known as off-label promotion.
And although the FDA requires drug companies to submit all promotional materials to the Office of Prescription Drug Promotion, the authors of the study asserted that FDA does not review all ads before they go live, citing a lack of resources at the agency. The authors suggested a solution to this would be instituting a user fee to ensure FDA has the bandwidth to review TV ads before they air.
Rules for off-label promotion are loosening in some states, according to Victoria Summers, associate principal at ZS Associates.
Arizona became the first state in 2017, for example, to allow drugmakers to communicate directly with doctors and insurers about alternative uses of approved prescription drugs.
With Scott Gottlieb at the helm of the FDA, off-label communication between drug sponsors and physicians may be encouraged further; In 2008, the future head of FDA advocated for the sharing of off-label information in an article he authored for Health Affairs.
The study is already generating pushback from pharma industry lawyers, according to co-author Jeanie Kim, a research fellow at Yale Law School.
"Our interpretation is it could be seen as misleading ... manufacturers cannot recommend or even suggest a use that's not approved in the labeling. We just interpret that in a very strict and narrow way ... if it's not a clinical indication on the first page [of the prescribing information document], then it's not an approved use," she said.
Still, there are some legal ways for pharma companies to mention certain benefits of drugs.
For example, if weight loss is included in the clinical trial section of the prescribing information of a diabetes drug, it's fair game to mention even if there is no label indication. Kim called this a gray area.
A notable drug worth mentioning is Victoza, which is one of the only drugs in this space that has been tested in clinical trials for the distinct indication of weight loss and management. It was approved by FDA and marketed as Saxenda by Novo Nordisk for this indication in April 2017.
"Victoza in its other form, Saxenda, is approved for weight loss by FDA, but what's interesting there is Saxenda's label says that Saxenda is not approved for diabetes type II." Added Kim, "It's this weird quagmire that's happening with weight loss and diabetes drugs."
Victoza and Saxenda both contain the active ingredient liraglutide, but the recommended dosage for the drug’s weight-loss indication is not the same as the optimal dosage listed in Victoza’s label for the management of diabetes.
Public Citizen wrote a letter to FDA in 2015 about weight-loss promotion in DTC ads for diabetes medications. But Kim said the agency didn't do much with that letter.
Too many options
Advertising for a drug in a crowded market may seem like a necessity for some pharma manufacturers to differentiate a product.
With "slimming margins and drugs being launched for smaller indications," there is a race for copycat advertisements, said Ben Locwin, a consultant and former pharmaceutical executive.
"If you can't be the ‘most memorable’ player or only name in the arena, then clouding the field of competitors' names is the next preferable option. There's also the prediction that diabetes will continue to grow with a growing and aging population, so [this condition is] a pretty safe bet for aggressive marketing campaigns," he added.
The disclaimers that raise the most flags are for the drugs used to treat diabetes.
For example, one ad notes, "Victoza is not approved for weight loss."
But then it goes on: "In our largest study, when added to metformin, people lost on average up to 6.2 pounds." Trulicity, Farxiga, and Invokana also had similar ads mentioning weight loss.
"Mentioning this benefit can be attractive to patients and helps generate interest. The study suggests that one brand marketing in this manner puts other brands at a disadvantage, and without FDA intervention, [it] may encourage other brands to do the same ... Drawing the line between information and promotion is part of the ongoing discussion around DTC messaging," said ZS' Summers.
Let’s talk patient cost
A perhaps more insidious persuasion tactic is the mention of price to indicate how "accessible" many of the medications are that are advertised on TV. Interestingly, 60% of ads reviewed in the study referenced methods of payment and potential savings, typically through the use of a patient copay card.
The FDA is currently conducting studies to determine what effect the mention of price can have on consumers when delivered through DTC advertisements. Results from the consumer-directed portion of the study have not yet been released to the public. The agency plans to post these findings following peer-review and publication in a journal.
Currently, manufacturers aren't required to make any statements regarding cost in their DTC advertisements, said Locwin, but mentioning cost savings compared with other medications could be persuasive, he added. As of now, it is not specifically prohibited.
- Journal of General Internal Medicine Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines