Regulatory Focus™ > News Articles > 2020 > 3 > OPDP Warns Pharma Company for Sponsored Link on Google

OPDP Warns Pharma Company for Sponsored Link on Google

Posted 02 March 2020 | By Zachary Brennan 

OPDP Warns Pharma Company for Sponsored Link on Google

In a first for 2020, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) late last month sent a warning letter to Outlook Pharmaceuticals because of a sponsored link on Google that did not include any risk information for its treatment for attention deficit disorder with hyperactivity.

“This misleading presentation is particularly alarming from a public health perspective given that the sponsored link utilizes claims such as, ‘Liquid Treatment Option’ and ‘Bubblegum Flavor’, that could appeal to parents as desirable properties for pediatric administration, but fails to communicate that ProCentra is a schedule II controlled substance associated with serious and potentially life-threatening risks, such as those contained in ProCentra’s Boxed Warning that describes the high potential for abuse of the drug and states that misuse may cause sudden death and serious cardiovascular adverse events,” OPDP said in its letter dated 21 February.

The warning also notes that the company failed to present the established name for ProCentra (i.e. dextroamphetamine sulfate) in the ad, thereby misbranding the product. OPDP said the FDA Bad Ad Program also received complaints regarding this sponsored link on Google.

FDA explains how the sponsored link includes claims and/or representations about the use and/or benefits of ProCentra such as, “Explore Your ADHD Medication Options For Your Child.” But without any risk information, the sponsored link “fails to provide material information about the consequences that may result from the use of ProCentra and creates a misleading impression about the drug’s safety,” OPDP said.

Stefan Antonsson, CEO of Outlook Pharmaceuticals, told Focus that the advertisement has been taken down and he will respond to FDA’s warning letter.

Warning Letter

Promotional Material

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe