Intuniv materials get FDA warning

Share this article:
Patient materials for Shire's ADHD drug Intuniv presented unsubstantiated effectiveness and superiority claims and downplayed important risk info, said the FDA's Division of Drug Marketing, Advertising and Communication.

In a June 22 untitled letter, DDMAC asked Shire to stop giving out an Intuniv “patient starter kit.” The agency said materials “use large and colorful headers to highlight benefits of Intuniv therapy, including a prominent and compelling image of a child in a large monster suit, while the risk information appears in small font and in single-spaced paragraph format, and in many cases only appears at the end of each piece.”
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?