Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

FDA Finds Sanofi and Celgene DTC Ads are Misleading

XTALKS VITALS NEWS

DTC Advertising

The FDA's Office of Prescription Drug Promotion (OPDP) ordered Sanofi and Celgene to discontinue the ads, in two separate letters to the drugmakers.

Share this!

December 16, 2016 | by Sarah Hand, M.Sc.

The US Food and Drug Administration (FDA) has identified two direct-to-consumer (DTC) ads for prescription drugs, which it believes misleads consumers in regards to the safety of the medications. The FDA's Office of Prescription Drug Promotion (OPDP) ordered Sanofi and Celgene to discontinue the ads, in two separate letters to the drugmakers.

Sanofi’s ad was in promotion of its diabetes drug, Toujeo (insulin glargine), and showed a man dancing to an upbeat song while a narrator disclosed the contra-indications and potential side effects of the drug. The FDA’s OPDP took issue with the ad’s rapid camera cuts and “attention-grabbing” visuals which could distract the viewer from the important risk information.

“The overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Toujeo,” said the FDA’s letter to Sanofi. “The presentation in the video is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”



Celgene’s ad for its severe plaque psoriasis drug, Otzela (apremilast), was similarly fast-paced, featuring four successive scenes while the narrator reads the risk information. In this case, the visuals were deemed to be too distracting, thereby minimizing the risks of taking the medication.

“The presentation of these compelling and attention-grabbing visuals and SUPERs, all of which are unrelated to the risk message, in addition to the frequent scene changes and the other competing modalities such as the musical interjections, compete for the consumers’ attention,” said the FDA’s letter to Celgene. “As a result, it is difficult for consumers to adequately process and comprehend the risk information.”

Since January, the OPDP has only issued five other letters like these to drugmakers. Still, they serve as a timely reminder that DTC ads must follow strict guidelines to ensure that benefit/risk information is presented equally.


Keywords: FDA, DTC Advertising, Risk Information


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Better Meal Planning for Diabetics Using a Predictive Blood Sugar App

April 21, 2017 - A new app could allow people with type 2 diabetes to make predictions about the impact of a meal on their blood sugar levels, before they even take a bite.

Featured In: Life Science News


Bacterial Biomarkers Could Make Diagnosing Colorectal Cancer Less Invasive

April 20, 2017 - Researchers at The University of Texas Health Science Center at Houston School of Public Health have identified specific strains of gut bacteria which have been associated with colorectal cancer.

Featured In: Life Science News


Weetabix Cereal Sold to Post in £1.4 Billion Deal

April 20, 2017 - The cereal was sold by Shanghai-based Bright Food, which acquired a controlling stake in the company in 2012.

Featured In: Food News

LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

What Medical Device Manufacturers Need to Know Before Developing a Biological Safety Evaluation

REGISTER FOR THESE WEBINARS

Electronic Informed Consent: 2017 Industry Survey Results


Critical CRO Oversight Metrics: How to Establish the Right Metrics and Monitor them in Real-Time


The Modernization of eCOA Technology for Clinical Trials


Developing a Biological Safety Evaluation


Copyright © 2016-2017 Honeycomb Worldwide Inc.