- The Food and Drug Administration dinged two more drugmakers for misleading marketing materials, issuing separate warning letters to Spriaso, LLC and United-Guardian, Inc. last week shortly after flagging Sanofi and Celgene for similarly offending DTC ads.
- The warning letters, issued last week but only posted online recently, censure Spriaso and United-Guardian for failing to communicate in digital marketing materials any risks associated with their respective drugs.
- After issuing only five letters to drugmakers through the first ten months of the year, the FDA's Office of Prescription Drug Promotion (OPDP) has sent four in December. The office sent nine last year.
Salt Lake City, UT-based Spriaso markets Tuxarin ER (codeine phosphate and chlorpheniramine maleate), an opiate agonist approved to treat cough and symptoms related to respiratory allergies and the common cold.
But on a webpage (now unavailable) describing the drug, Spriaso failed to include any risk information about the product — an oversight the FDA found particularly problematic given the risk of overdose and dependence tied to opiate agonists.
Additionally, Spriaso suggested Tuxarin is safer than competing products without any evidence to back up those claims.
United-Guardian, on the other hand, ran into trouble with a professional email marketing an irrigation solution for patients with catheters.
Like Spriaso, United-Guardian failed to include any risk information. Instead, the company included a link labled "Click here for full prescribing information." Unfortunately for United-Guardian, the FDA frowns upon the practice of placing risk information in another location other than directly where a drug is advertised.
The OPDP ordered both firms to "immediately cease" misbranding each drug, requesting a letter explaining the respective company's plan for stopping use of the materials. Additionally, each drugmaker will have to submit a separate plan of action to disseminate messages which correct the issues flagged by the OPDP — merely taking down the ads is insufficient.