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
New Approach Could Allow Red Blood Cells to be Manufactured

March 27, 2017 - UK researchers at the University of Bristol have developed an immortal line of early adult erythroblasts capable of continuously producing mature red blood cells.

Featured In: Biotech News


Lung Cancer Recurrence Could Be Better Detected Using Biomarker Blood Test

March 24, 2017 - The results of a recent prospective clinical trial found that a biomarker blood test could detect lung cancer recurrence a full six months before imaging methods could spot the disease.

Featured In: Biotech News


Use of Testosterone Treatments Boosted by DTC Ad Campaigns

March 24, 2017 - Those with a stake in the pharmaceutical industry often question the effectiveness of direct-to-consumer (DTC) advertising, and whether it truly influences consumers to talk to their doctors about medical conditions and perhaps even ask for drugs by name.

Featured In: Pharmaceutical Marketing News

LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems?

REGISTER FOR THESE WEBINARS

How to Improve the Speed and Efficiency of Your Clinical Trials


High Performance Computing for High Content Screening - A Case Study


The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review


Treatment of Psoriasis: Improvements Through Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.