The intersection between kids and pharmaceutical advertising is nothing if not a sensitive subject.
When the US Food and Drug Administration (FDA) unexpectedly eased advertising restrictions in 1997, allowing pharmaceutical companies to market their products directly to consumers (DTC) for the first time in decades, a tsunami of advertising was released onto the public.
While advertising spending by the industry peaked in 2006 at $5.4 billion, the industry still spent a considerable $3.47 billion on advertising in 2012 according to Fierce Pharma. The vast majority of this spending goes toward television advertisements.
And, as Focus has reported on in the past, those advertisements make their way in front of both adults and adolescents. And while some parents might not care if their child sees an advertisement for a medication to treat rheumatoid arthritis, plenty would rather avoid explaining to their children what erectile dysfunction is.
Cognizant of those concerns, industry has passed through its trade group, PhRMA, a set of "Guiding Principles" intended to limit advertising aimed at consumers. Among them: respect for the seriousness of the condition, accuracy of the advertising, fostering responsible communications between patient and provider, making FDA aware of all advertisements before publication, the availability of other treatment options, a clear association of the product with the condition so as to reduce off-label implications, and appropriate for the age the advertisement is likely to be seen by.
Signatories to the code are required to self-certify that they are in compliance with the guidelines, and PhRMA maintains an office of compliance that investigates allegations of deficient advertising practices by its members and is capable of punitive actions.
But as a study released last year shows, this effort has not exactly been successful, with kids viewing erectile dysfunction ads an estimated 102 billion times. As any American who watches Football games can attest, such ads are a ubiquitous presence on television.
Advertising Toward Kids: Are Adjustments Needed?
What that study doesn't look at however is how adolescents react to drug advertising in general. And that distinction is one that FDA now says it wants to study.
In a 30 October 2013 Federal Register posting, FDA said it has a number of "potential concerns" about advertising aimed at or otherwise exposed to children. "Adolescents are a unique audience for DTC drug marketing because their cognitive abilities are different than those of adults, and they are usually dependent on adults for health insurance coverage, health care provider access, and prescription drug payment," FDA explained.
Despite these widespread concerns, FDA acknowledged that there is presently "limited" research that has been conducted in this particular area. In existing research, if age is considered at all, researchers have generally failed to "consider how information processing in response to ad exposure might differ among adolescents versus older viewers."
As FDA notes further on in its posting, it's not just important to portray information accurately. "Other factors can also affect potential consumers" as well, such as the capacity to process information, the "vividness" of the information, and the ability of a consumer to process benefit-risk information.
According to the document, regulators seem to be preparing to make the case-or at least trying to prove their hypothesis that-adolescents should be treated as a "unique life stage during which vulnerabilities that can affect informed decision-making must be taken into account."
"Different cognitive, social and emotion, and developmental processes in the adolescent brain mature simultaneously and at different rates, affecting decision-making by age," FDA continued. "All of these factors can influence how adolescents perceive and process information as well as weigh risks and benefits."
Perceptions of Risk a Particular Concern
And with the risks of some drugs marketed toward teenagers (i.e. acne medications) containing serious risks like suicidal ideation, regulators are considering the need for new ways to present risk information to adolescents "in ways [they] can understand."
To assess their hypothesis, regulators said they plan to conduct a controlled study involving two different medical conditions for attention deficit hyperactivity disorder (ADHD) and acne. Adolescent study subjects will be exposed to different types of DTC advertising, with their views compared to those of young adults. Some parents would also be involved in the study and matched to their respective children to "explore similarities and difference in perceptions."
Regulators theorized that adolescents would be more apt to pay attention to short-term benefits, and less attention to long-term risks, as "adequate perceptions of their own vulnerability has not been determined."
Comments on the study are due by the end of 2013.
FDA Study Proposal