On October 24, 2013, the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) issued an Untitled Letter to Sunovion Pharmaceuticals for misleading patient brochures regarding its drug, Brovana (arformoterol tartrate) Inhalation Solution.
According to the Untitled Letter, the patient brochures are misleading because they overstate the efficacy of Brovana, make unsubstantiated claims, including unsubstantiated superiority claims, and minimize the risks associated with the drug. As stated in the Untitled Letter, the totality of the claims and presentations set forth in each of the brochures, along with the headline claim in each ("With the right COPD medicine, you may get back to daily living"), suggests that Brovana is clinically superior to other available COPD therapies. OPDP noted that it is not aware of any adequate or well-controlled head-to-head studies supporting the implication that Brovana is clinically superior to other COPD therapies.
In addition, per OPDP, the patient brochures prominently present efficacy claims in large, bolded font size and colorful text and graphics surrounded by a significant amount of white space. The risk information, in contrast, is presented in small font, surrounded by little white space, and in single-spaced format. According to OPDP, the overall effect of this presentation undermines the communication of important risk information, and misleadingly suggests that Brovana is safer than has been demonstrated by substantial evidence or substantial clinical experience.
Prior to this letter, the last OPDP enforcement letter was issued on July 31, 2013, to Merz Pharmaceuticals, LLC.