FDA to study limiting lists of drug risks in TV ads

The Food and Drug Administration wants to study how consumers would respond to prescription dug TV ads that list only a limited number of a product’s side effects. 

Regulations now require direct-to-consumer prescription drugs advertisements aired on TV and radio to list the products’ major risks in an audio or an audio and visual part of the ad. 

But FDA is concerned that major risk statements are too long and the information is getting lost on consumers. There is also concern that some ads are leaving out risk information. 

A possible solution, FDA said would be to limit the risks listed in the statements and include a disclosure alert to let consumers know there are other side effects not listed in the ad. 

For example, the ad would say, “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information.” 

“Our primary hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks,” FDA said in its notice in the Federal Register. 

FDA’s Office of Prescription Drug Promotion plans to investigate the effectiveness of the “limited risks plus disclosure” strategy by having a sample of adults, who self-identify as having been diagnosed with depression, high cholesterol or insomnia, watch ads for drugs pertaining to their diagnosis and answer questions about the information in the ad. 

FDA is waiting for the Office of Management and Budget to sign off on the study. The public has 30 days to comment.