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TREATMENT IND EDUCATIONAL MATERIALS: PRECLEARANCE WITH FDA

Executive Summary

TREATMENT IND EDUCATIONAL MATERIALS: PRECLEARANCE WITH FDA advised by FDAer Sharon Risso at a Jan. 30 Food and Drug Law Institute seminar on the promotion and advertising of biologics. Risso works in the Center for Biologics Evaluation and Research's Division of Product Certification as chief of the Vaccines & Therapeutic Products Branch. "For those companies that hold Treatment INDs, we for the most part have looked at...the physicians' brochures, informed consents, and patient instruction information" prior to distribution, Risso observed. CBER is coordinating with its counterpart in drug evaluation (CDER) "very carefully" on the issue, Risso added. "Both groups are trying to develop a policy where we could disseminate informal guidance on Treatment INDs." Treatment INDs raise questions for the agency's advertising regulators, Risso indicated, because the process of encouraging physician and patient participation may "muddy the water a bit when it comes to...interpreting the basic prohibition that 'thou shall not promote' [products for unapproved uses]." "Make it clear to everyone, including the sales force, that this is an investigational product," Risso advised. "Make no claims about safety and efficacy. The safety and efficacy data that you submitted to the agency to support the approval of your Treatment IND should be used as a basis for defining benefit versus risk to the patient population that you are approved to treat -- and nothing more," Risso declared. Risso also stressed that companies with Treatment INDs underway "must be careful about where those informational items are disseminated...you need to direct this information to the specific patient population for which the Treatment IND was approved. A very general, unrestricted informational piece will require extreme due diligence on the part of the company to assure us that it is not being disseminated to other patient population areas."

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