FDA Weighs Limited Risk Info in DTC Ads

Posted 21 August 2017 | By Michael Mezher 

FDA Weighs Limited Risk Info in DTC Ads

The US Food and Drug Administration (FDA) on Friday announced it is considering a new approach to presenting risk information in direct-to-consumer (DTC) television and radio ads that would allow drugmakers to limit the amount of risks presented.

Currently, DTC drug ads are required to present a product's major risks alongside its benefits to ensure a "fair balance" of information. But FDA and industry have long debated over the best way to present that information.

According to FDA, there are concerns that the risk statements in DTC broadcast ads are too long, which could result in consumers not understanding or minimizing the importance of a product's risks.

Under the new approach, FDA would allow drugmakers to limit the risks listed in broadcast ads to severe (life-threatening), serious or actionable risks, and require that the ad include a disclosure that not all risks were included, such as "This is not a full list of risks and side effects. Talk to your health care provider and read the patient labeling for more information."

The announcement comes just weeks after a study by FDA officials suggested that presenting limited risk information in DTC television ads could improve consumers' ability to recall those risks and after the Pharmaceutical Research and Manufacturers of America (PhRMA) criticized FDA's research efforts on prescription drug advertising for lacking a clear vision for how the research protects public health.

"FDA's own research on broadcast TV drug advertisements suggests that a more targeted method for delivering risk information may lead to better retention of those risks," FDA Commissioner Scott Gottlieb said, adding that the agency's goal "is to make sure consumers who view broadcast ads walk away properly informed of the key potential tradeoffs of using a prescription medicine."

Now, FDA is asking for input from the public on the potential impact of requiring less risk information in DTC broadcast ads.

FDA says it is particularly interested in responses that highlight existing data on how well consumers understand benefit and risk information under the current approach.

The agency also says it wants input on the potential tradeoffs of limiting the types of risk information required for broadcast ads and on the impact of including a disclosure statement that lets viewers know that the drug has risks that were not listed in the ad.

In addition, the agency says it wants input on how to identify risks that are most relevant to patients versus ones that prescribers and physicians should be more aware of.

FDA also notes that some drugs do not have any severe, serious or actionable risks, and says it wants input on what risk information it should require in ads for those products.

FDA, Federal Register

Categories: Regulatory News

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