The FDA has recently announced that the agency could be changing the current rules regarding the presentation of risk information in direct-to-consumer (DTC) television and radio advertisements.

Currently, ads are required to list all the known risks associated with a drug product. However, there has long been debate over whether too much risk information is actually counterproductive. Many believe that long lists result in a lack of understanding among consumers as well as an inability to recall the risks mentioned.

To address these concerns, the FDA is now considering a more targeted approach. FDA commissioner, Scott Gottlieb, believes it could be more effective to list only the severe, life-threatening, and serious risks, and to include a disclosure letting viewers know that not all the risks were mentioned and that patients should consult with their healthcare professionals for more information.

However, before any changes are made, Gottlieb will first have to assess whether this new approach will further the agency’s goal of ensuring consumers watching the ads “walk away properly informed of the key potential tradeoffs of using a prescription medicine.”

To help Gottlieb achieve this, the FDA is now asking for input from the public. The agency is most interested in receiving input that will help it answer the following questions:

  • How well do consumers understand the benefit and risk information when it is presented under the current system?
  • What are the expected tradeoffs of limiting the amount risk information?
  • How can the FDA identify the risks that are most relevant to patients/consumers versus the risks that are more important for prescribers and physicians?
  • For ads pertaining to drugs that do not have any known severe or serious risks, what risk information should be included?

To learn more about the FDA’s review process, or to submit input to the agency, visit the Federal Register.