Two US drug companies, ONY Inc., and Cornerstone Therapeutics Inc., were reprimanded by the Office of Prescription Drug Promotion, Division of Professional Drug Promotion of the Food and Drug Administration (FDA) with untitled letters that allege the companies made false or misleading claims on their websites or in press releases regarding drugs that treat neonatal Respiratory Distress Syndrome (RDS). ONY Inc. and Cornerstone Therapeutics Inc. were recently involved in litigation with each other over their RDS treatment, stemming from ONY’s allegations that Cornerstone manipulated data and studies involving their RDS drug, Curosurf®.
According to the FDA letter to ONY Inc., “[p]romotional materials are misleading if they contain a drug comparison that represents or suggests that a drug is safer or more effective than another drug, when this has not been demonstrated by substantial evidence or substantial clinical experience.” The FDA then lists numerous instances where ONY Inc.’s website claims that its RSD drug, Infasurf® provides clinical superiority when compared to other RSD drug treatments. The letter also indicates that ONY Inc. failed to include pertinent risk information for Infasurf® on its webpage, specifically the risk of the patient requiring reintubation or resuscitation. Although the webpage had a direct link back to the product label, which included all applicable risk information, the FDA found the omission of those two risks to be misleading.
The FDA’s letter to Cornerstone Therapeutics Inc. concerned statements made in the company’s professional pitch letter and press release for Curosurf® that omitted risk information and made misleading statements regarding the drug’s superiority to other drugs marketed for the same disease. According to the FDA, the pitch letter failed to communicate any risk information associated with the drug, which could indicate that Curosurf® is safer than has been demonstrated. The FDA noted that the attached press release contained an “Important Safety Information” section, but that it did not mitigate the omission of information from the pitch letter. The FDA also informed Cornerstone Therapeutics Inc. that it failed to present the drug’s established name (poractant alfa) in direct conjunction with its proprietary name, Curosurf®, which is required by 21 CFR 201.10(g)(1).
Both companies were requested to immediately cease with the dissemination of the violative material and to submit written replies to the FDA stating whether they intend to comply with the request.