In response to a warning from the Food and Drug Administration, Vienna-based CEL-SCI Corp. says it has corrected statements on its website about a cancer drug that is currently in clinical trials.
CEL-SCI received a letter on Aug. 5 from the FDA’s Division of Drug Marketing, Advertising, and Communications warning that statements about that the drug Multikine violated FDA regulations.
The letter said CEL-SCI’s website promoted Multikine as “safe and effective when the product has not been approved by the FDA and the promotional claims made have not been demonstrated by substantial evidence or substantial clinical experience.”
In a news release, CEL-SCI said it has revised statements on the website and taken additional actions to ensure information about the company’s R&D activities and drugs are in full compliance with FDA requirements on promotion and advertising.
”As a data-driven, research-based biopharmaceutical company, CEL-SCI has always actively engaged in a full exchange of scientific information, including disseminating scientific findings and communicating them through lay media outlets consistent with FDA’s regulations on investigational drugs,” Geert Kersten, the CEO of CEL-SCI, said in a statement. “We have now stepped up our proactive compliance initiatives to ensure that we remain within the regulatory framework for such scientific-information-exchange.”