FDA mulls change to drug ad rules

The US Food and Drug Administration has issued a statement requesting input on a possible change to the rules governing statements about drug safety in pharmaceuticals advertising.

Recently inaugurated FDA Commissioner Scott Gottlieb said: “In addition to providing consumers with the benefits of the potential treatment, today’s direct-to-consumer prescription drug advertisements must also present the risks."

"But if the risks aren’t provided in a way that consumers understand, they may not be able to appropriately weigh the benefits and risks.”

“The 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.”

The FDA is considering limiting the risks in the major statement included in most drug advertisements to only those that are severe, serious or actionable, coupled with a disclosure to alert consumers that there are other product risks not included in the advertisement.

“Our goal is to make sure consumers who view broadcast ads walk away properly informed of the key potential tradeoffs of using a prescription medicine,” said Dr Gottlieb.

Details on how to submit feedback on the matter are provided on the Federal Register notice.



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