Executive Summary

FDA BIOLOGICS CENTER IS TARGETING PROMOTION OF IND CLAIMS for drugs and unapproved use claims, Center for Biologics Evaluation and Research Vaccine & Therapeutic Products Branch Chief Sharon Risso told a Food & Drug Law Institute meeting on July 16. CBER intends to focus "on the most troublesome [promotional] activities," Risso said. "With biologics, this is with the promotion of investigational new drugs and the promotion of approved drugs for unapproved uses." Such promotion takes place "through [Securities & Exchange Commission] statements, through press releases, and through so-called scientific exchange seminars," Risso said. A second area of concern, Risso continued, is with "unsubstantiated comparative" claims. There are "very few instances where comparative claims are valid, unless they are based on the results of an adequately controlled clinical study which actually compared your product against your competitor's," she maintained. Comparative studies should "show statistical significance in the outcome parameters that the study was prospectively designed to measure." In response to a question, Risso said the "very few instances" where a comparative claim could be made without a study would include differences in structure or purity, but not differences in a drug's benefit to patients. Risso linked CBER's concern to an agency-wide trend. "It is an understatement to say that Commissioner Kessler is interested" in the promotions issue, Risso said. "All centers are involved." Kessler penned an article on promotional abuses in the July 18 issue of The New England Journal of Medicine in which he targets both promotion of unapproved products or indications and comparative claims ("The Pink Sheet" July 22, p. 16). Discussing the ad/promotion crackdown, Risso cautioned against thinking that CDER's advertising regulatory decisions do not apply to CBER. "For the most part, the regulation, the guidance on promotional materials and the policies that have been disseminated by the Center for Drugs are in fact totally applicable to biologics regulation," Risso told FDLI. CBER Office of Compliance Director Thomas Bozzo agreed with Risso that promotion of unapproved products is a leading "topical issue" confronting his office. He told the FDLI meeting that, as part of the agency-wide advertising enforcement initiative, criminal referrals for firms guilty of repeated mispromotions are "a possibility." In the past, Bozzo said, FDA has been willing only to refer cases of fraud to the Justice Department for prosecution. However, "the Center for Biologics and the agency at large have discovered that, in fact, there are some other cases that need to be referred also, because they represent continuing violations . . . [that] are representative of -- for lack of a better term -- a reckless disregard for the standard." Bozzo predicted that "we'll be seeing a number of criminal cases that are referred to the Department of Justice that will not have a fraud component to them."