On January 4, 2017, the United States Food and Drug Administration (FDA) published a Notice in the Federal Register, requesting comments on research, “Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion.” While empirical research has been conducted on the occurrence and influence of deceptive promotion, there have been no studies done to determine how well consumers and healthcare providers can identify false or misleading drug promotion claims. According to the FDA, this ability has “important public health implications.”
The FDA’s concern is that if consumers are unable to identify deceptive promotion, they “may ask their HCPs to prescribe specific drugs that they would not otherwise request. Likewise, HCPs unable to identify deceptive promotion may prescribe specific drugs that they would not otherwise prescribe.”
If the study shows that consumers and HCPs are able to identify deceptive promotion, “then they may instead be equipped to incorporate such information into their medication decisions, and perhaps even report deceptive promotion” to the FDA through its Bad Ad program, the notice states. Bad Ad program reports “are useful to FDA because they allow investigators to focus their efforts in an era where the amount of promotion far exceeds the resources available to monitor everything.” While the FDA’s Bad Ad program currently requests that HCPs report deceptive promotion, it is possible that as a result of the study findings, the FDA expands that program to include consumer reporting.
The Proposed Studies
The proposed research calls for two studies, conducted simultaneously, focusing on chronic pain and obesity, to be administered to both consumers and healthcare providers using mock websites tailored to each audience.
Study 1, focused on chronic pain, will allow the agency to assess consumer and healthcare provider response to promotional websites with varying degrees of false or misleading presentations. This study is expected to answer some of the following questions:
- What proportion of consumers and healthcare providers correctly identify a deceptive promotional piece?
- Does the number of deceptive claims affect that proportion?
- Does the degree of deception affect attitudes and behavioral intentions toward the promoted drug, including intended reporting to the FDA?
- Do these audiences adjust their attitudes and intentions if they recognize the deceptive promotion?
Study 2, focused on obesity, will focus on the type of deception (implicit versus explicit) and will compare consumer and healthcare provider perceptions and beliefs about a drug following exposure to varying types of deceptive claims and answer similar questions as those addressed in Study 1, but with different context.
Comments Requested
Unfortunately, this proposed study presumes that companies are purposefully deceiving the public. The FDA is seeking comment on this proposal until March 6, and it is an opportunity for industry to participate in DTC decision making under a new administration – one that is led by someone who has promised to “reform the FDA.” While the notice focuses on deception, stakeholders can also comment on the positive public health potential of appropriately regulated consumer promotion.
The FDA is looking for comments on the following topics: whether the proposed study is necessary for the proper performance of FDA’s functions; is the FDA estimate of the study’s information collection burden accurate and are the methodology and the assumptions used valid; are there ways to enhance the quality, utility, and clarity of the study; and whether there ways to minimize the burden of the collection of information.