Healthy Skepticism Library item: 8445

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Marcus D.
FDA approval of comparative claims for prescription drugs--the Moxam case.
Drug Inf J 1983; 17:(3):171-5

Abstract:

FDA allowance of comparative claims as part of the approved labeling for new prescription drugs creates special problems. Claims contained in prescription drug labeling are viewed by physicians as embodying not just the normal puffery of the manufacturer, but the considered views of government agency charged with protecting public health. Thus, labeling claims for prescription drugs have an impact and significance that promotional claims for other products do not. In the Moxam case—a dispute between Upjohn and Lilly over the FDA’s approval of a comparative claim for a new Lilly antibiotic—the agency recognized this fundamental reality. Faced with the prospect of having to provide a procedure to permit competitors to challenge approval of comparative claims, the FDA has moved toward a policy of not permitting such claims in labeling, while allowing them in advertising.

Keywords:
Advertising Anti-Bacterial Agents Drug Labeling/standards* Legislation, Drug* Prescriptions, Drug United States United States Food and Drug Administration