Not just the approved indications: FDA to study DTC drug ads that include secondary endpoint data
While most of the world bans direct-to-consumer advertising for prescription drugs, the FDA said Friday that it’s launching a study into how people might perceive such ads that include information on secondary endpoints that are not part of an approved indication.
The online research will examine the impact of adding a disclosure about a secondary claim (i.e. clinical benefit information based on a secondary endpoint reported in a product’s approved labeling) in DTC and healthcare provider-directed online promotions.
“In some cases, truthful and non-misleading presentations about secondary endpoints in well-designed clinical studies can provide reliable information about treatment effects that may be distinct from the treatment effects described in the product’s indication statement,” FDA said in the Federal Register explaining the need for the research.
The agency offered the example of a cancer drug indicated to treat a specific type of cancer based on a primary endpoint of survival, whereas a secondary endpoint in the study may provide data about an additional distinct benefit, such as functional status.
For this research, the agency is focusing on diabetes drugs and the secondary claim disclosure that explains “even though the drug is not indicated for weight loss, that it can help some people lose weight.”
One commenter on the research said it “lacks practical utility” because it treats the secondary benefit claim as not related to the product’s indicated uses.
But FDA said it’s not making any generalizations about the approval status of the secondary claim, adding, “In this scenario, a disclosure about the secondary claim may help the audience interpret the secondary claim and provide context. The purpose of this study is to evaluate such disclosures about this specific type of secondary claim and measure the impact on perceptions of and attitudes toward the product.”
In response to another question on whether it’s appropriate for the FDA to study the practice of medicine, the agency defended the need for this research, claiming, “It is a proper subject for FDA research to study whether particular framing of statements contributes to an HCP’s accurate understanding or to misunderstanding about drugs to inform their prescribing decisions in the course of their practice of medicine.”
In addition to the secondary claims research, the agency also said it’s working on another study related to the disclosure that a certain product is a biosimilar.
FDA said the purpose of that study is “to understand whether participants would ask their doctor to switch their medication after viewing the ad.”