The U.S. Food and Drug Administration has scolded Bristol Myers Squibb for making false and misleading claims about a lung cancer treatment on a website aimed at physicians.
In an Aug. 1 letter, the agency admonished the company for touting the benefits of its Krazati medication by referencing efficacy data that did not support statements on the website designed for health care providers. In particular, the FDA cited a study purportedly showing the medication controlled the disease — based on a composite — even though the study was not designed to demonstrate that.
“It is misleading to include in promotional materials representations or suggestions that rely on a study or studies whose design is not capable of supporting such representations or suggestions,” the letter stated. “The calculations … are not supported by the data cited.” The agency noted the study was a single-arm trial, so it could not be known whether the data cited should be attributed to the treatment.
