To establish a drug product’s effectiveness by “substantial evidence,” the Food and Drug Administration (FDA) has generally indicated that such evidence should consist of two adequate and well controlled clinical investigations. Recently, three Notice of Violation (NOV) letters issued by the Division of Drug Marketing, Advertising, and Communications (DDMAC) suggest that the pharmaceutical industry may experience greater difficulty when using results from open-label studies to make claims regarding clinical efficacy in promotional materials. Open-label studies refer to clinical trials where both the investigators and the study participants know the treatment the participant is receiving and are distinguished from blinded studies with a control. Although the agency has not prohibited the use of open-label studies as potential support, these letters collectively reflect DDMAC’s increased scrutiny of study design when determining whether substantial evidence has been provided to support marketing claims regarding the benefit or efficacy of a drug product.
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