The Agency has proposed studies designed to detect healthcare professionals’ (HCPs) and consumers’ abilities to detect misleading information on mock pharmaceutical websites.
Prescription drug promotion can include “false or misleading (collectively, deceptive) claims, images, or other presentations,” said the US Food and Drug Administration (FDA) in a statement yesterday, adding that such promotion can include representations that a drug is more effective or less risky than is demonstrated by appropriate evidence.
In the study HCPs will view mock pharmaceutical websites – created to be ‘generally indistinguishable’ from currently available drug websites – targeted towards physicians, and consumers will view mock consumer-targeted pharmaceutical websites.
Both groups will be asked to identify the number of deceptive promotion pieces, as well as the type of deception in the promotion (implicit versus explicit).
The Agency said deceptive promotion could have health implications for consumers.
If consumers are unable to identify deceptive promotion, they may ask their HCPs to prescribe specific drugs that they would not otherwise request, said the FDA.
“Likewise, HCPs who are unable to identify deceptive promotion may prescribe specific drugs that they would not otherwise prescribe,” it added.
The Agency also said the study would help it identify best practices for addressing false and misleading claims.
Illegal pharma promotion?
Pharma marketing expert John Mack (also known as the Pharmaguy) told us “Not only is it [deceptive promotion] a big issue, it’s the only issue.”
Pharmaceutical promotion representing drugs as more effective or less risky than demonstrated by appropriate evidence accounted for the majority or cited FDA violations in 2015, he told us.
While Mack said the proposed studies will help the FDA compare how consumers and HCPs differ in their perceptions of what is ‘deceptive,’ he told us the only way to curb deceptive drug promotion is to ban its practice.
“Of course, that will never happen….as far as I know, no drug marketer has ever been fired for creating a deceptive drug ad,” he told us.
Mack suggested the FDA’s decision to focus on websites for the study reflected an acknowledgement of the media platform’s scope and influence.
“Perhaps the US FDA is recognising that some media may be more influential than others,” he said.