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CBER AD STAFF MAY NO LONGER SEEK PRECLEARANCE OF ALL BIOLOGICS

Executive Summary

CBER AD STAFF MAY NO LONGER SEEK PRECLEARANCE OF ALL BIOLOGICS ADS as previously required, Center for Biologics Evaluation and Research Advertising and Promotional Labeling (APL) staffer Toni Stephano said at the annual BioEast '93 biotech conference Jan. 27 in Washington, D.C. "In an effort to be more responsive to industry, given the limited resources of the staff, one of the major changes under consideration is that sponsors of all advertising and commercial material will not be required to preclear all material before publishing or disseminating it," Stephano said. The newly created APL staff, formed during the recent reorganization of CBER, will include two full-time people, Stephano and Alex Kosyak, who were previously consumer safety officers in CBER's Division of Product Certification. That division, which was dissolved, was responsible for reviewing advertising for biologics prior to the reorganization. Drug Marketing, Advertising, and Communications Division staffer Bill Purvis is serving as acting supervisor of the group. Stephano said the staff will "continue to request submission and preclearance of all introductory advertising and promotional material upon licensing of a new product or approval for additional indications of an existing product before it is used." She noted that "this follows the procedure currently used by [DMAC]...for all newly approved prescription drugs." Submission of all "introductory advertising and promotional pieces should be submitted in duplicate to the review staff following the receipt of an approval letter," Stephano said. However, "materials generated regarding a novel biologic product or existing product using a new technology or a product to be distributed to a new market may be submitted prior to the receipt of an approval letter." The APL staff will ensure that advertising and promotional material for biologics adhere to four basic elements, Stephano said. The four elements provide that promotional materials: "are not false or misleading in any particular manner"; are "consistent with the current approved labeling"; "present fair balance of information about the product"; and that "proper prescribing information is included." Like the drug advertising group, CBER's APL staff plans to issue "notice of violation letters to the sponsors of the materials which do not conform to the approved product circular of clinical data used to approve the product." The letters will request that the promotional material be discontinued. "Should there be reason for further contact with the sponsor about violative advertising or promotion involving more serious or repeat offense, the new staff will request a new warning letter be issued," Stephano advised. All correspondence to the APL staff should be sent to the following address: FDA, Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Staff, HFM-202, Suite 200 North, 1401 Rockville Pike, Rockville, Md. 20852-1448.
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