The US Food and Drug Administration (FDA) is seeking views on whether the risk warnings included in direct-to-consumer (DTC) ads for prescription drugs should be made shorter.
Current regulations require DTC ads on television and radio to present the product’s major risks in either audio or audio and visual parts of the ad. This is called the “major statement.”
But there are concerns that the major statement is often too long, and that this may result in reduced consumer comprehension, minimisation of important risk information and, potentially, therapeutic non-compliance due to fear of side effects, say the FDA.
However, at the same time, there is also concern that DTC TV ads do not include adequate risk information or that they leave out important information, it adds.
A possible solution to these two conflicting viewpoints, the agency suggests, is to limit the risks in the major statement to those that are “serious and actionable,” and add a disclosure to alert consumers that there are other product risks not included in the ad.
For example, says FDA, the disclosure could be: “This is not a full list or risks and side effects. Talk to your doctor and read the patient labelling for [drug name] before starting it.”
Officials are planning to test the effectiveness of this “limited risks plus disclosure” approach through consumer questionnaires, conducted online, of people aged 18 and over who self-identify as having been diagnosed with one of three possible medical conditions.
Participants will be randomly assigned to view one of the following four possible versions of an ad:
I: presenting the full major statement without the disclosure regarding additional risks, as currently presented in the marketplace;
II: including the major statement plus the disclosure about additional risks;
III: including an abbreviated statement of risks without the disclosure about additional risks: and
IV: including an abbreviated statement of risks as well as the disclosure about additional risks.
People who work in healthcare or marketing will not be eligible to take plart in the study.
“Our hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure abut additional risks will promote improved consumer perception and understanding of serious and actionable drug risks,” says the FDA.
“We will also investigate other questions such as whether overall drug risk and benefit perceptions are affected by these changes,” it adds.