STAT+: FDA scolds Bristol Myers over a misleading website for a cancer treatment
The U.S. Food and Drug Administration has scolded Bristol Myers Squibb for making false and misleading claims about a lung cancer treatment 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 a 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.
