Less Than Effective Drug

50.4.6 - Less Than Effective Drug (Rev. 1, 10-01-03) B3-2049.4.C.5 This is a drug that has been determined by the Food and Drug Administration (FDA) to lack substantial evidence of effectiveness for all labeled indications. Also, a drug that has been the subject of a Notice of an Opportunity for a Hearing (NOOH) published in the “Federal Register” before being withdrawn from the market, and for which the Secretary has not determined there is a compelling justification for its medical need, is considered less than effective. This includes any other drug product that is identical, similar, or related. Payment may not be made for a less than effective drug. Because the FDA has not yet completed its identification of drug products that are still on the market, existing FDA efficacy decisions must be applied to all similar products once they are identified.