The U.S. Food and Drug Administration (FDA) has sent warning letters to competing drug manufacturers for allegedly promoting their neonatal respiratory distress syndrome treatments using “unsubstantiated superiority claims” that also “omit and minimize important risk information, and present unsubstantiated claims for the drug product.”
According to FDA, the studies cited in the promotional materials, including Webpages and video, do not support the product claims thus making the products misbranded in violation of the Federal Food, Drug, and Cosmetic Act. FDA’s Office of Prescription Drug Promotion requests that the companies immediately cease disseminating these promotional materials and respond by November 15, 2012, “stating whether you intend to comply with this request” and explain their plans for discontinuing the use of violative materials.
The company targets, ONY Pharmaceuticals and Cornerstone Therapeutics, reportedly have a history of “behaving badly.” In 2011, ONY evidently sued Cornerstone, its foreign parent, a scientific journal, and the authors of a study appearing in the journal, claiming they “cherry-picked” and “manipulated” data in a way that unfairly disparaged ONY’s product. The study apparently claimed that Cornerstone’s drug significantly reduced the risk of death when compared with ONY’s product. According to ONY, Cornerstone’s parent sponsored the study, three of the four authors served as the parent’s consultants and the fourth worked as a contractor for the parent. Two of the four authors purportedly served on the journal’s editorial board.
A federal court reportedly disagreed with ONY, ruling that the courtroom was not the appropriate forum for this dispute. Because the study disclosed the criteria used to reach its conclusions and the intended readers are a “highly specialized group” with “a well-developed understanding of the issues facing biomedical research,” the court determined that the scientific debate must be resolved in the scientific community. See Pharmalot, November 8, 2012.