FDA DRUG AD DIVISION STAFF-UP

FDA DRUG AD DIVISION STAFF-UP has brought four new recruits to the division's ad regulation branch since the beginning of the year. The new staffers are Maureen Knippen, who has a doctorate in nursing from the National Institutes of Health Clinical Center with experience in rheumatology trials; Joseph Griffin, a pharmacist/attorney recently graduated from the Northeastern University Law School; Chester Trybus, a consumer safety officer from FDA's medical devices regulatory center, and Igor Cerny, a PharmD, who is transferring to the regulation branch from the labeling and education branch within the agency's division of marketing, advertising and communications. The agency is reportedly close to bringing on three more recruits: another pharmacist/lawyer, an MD and a former district sales manager for a pharmaceutical company. The agency plans to have eight to 10 new employees in the regulation branch by the beginning of October. FDA's drug advertising division already has a wide array of projects both underway and planned that will require the greater resources. Among the new projects are a hotline to solicit comments on excessive promotional campaigns and a renewed interest in the activities and approaches of pharmaceutical sales reps ("The Pink Sheet" May 27, T&G-1). As a direct result of FDA's attempt to build up its enforcement image, the agency's drug ad activities are drawing renewed interest from the regulated industry. Under new acting director Ann Witt the agency is taking a more spirited and demanding posture in discussions of alleged violations. FDA memos of the negotiations with Bristol-Myers Oncology over a challenged publication exhibit interest on FDA's part in the public resolution of differences (see preceding T&G). According to the agency's account of a meeting with Bristol in mid-April of this year, FDA warned the company that if it did not meet the agency's expectations for correcting the inappropriate promotional messages, then FDA was prepared to send out its own corrective message. It was explained to the firm, an FDA memo states, "that we plan to pursue unilateral dissemination of necessary remedial information in this case, by adequate means, if the firm does not agree to do so." Several weeks later, as Bristol and the agency neared an agreement on a "Dear Doctor" letter, the agency noted that the company's lawyers requested the opportunity to see how the agency would portray the agreement to the public before the information was released. "The firm's counsel," FDA reported, "suggested that they be allowed to examine any FDA communication to the public, e.g. a press release, for 'content and tone' prior to the transmission, and that they also be allowed to concurrently transmit a statement to that community." FDA, which itself was seeking preclearance authority over future Bristol oncology promotions, was not inclined to permit the company similar review over its pronouncements. Witt told Bristol's lawyers that FDA "would consider their request to 'preclear' our press releases." FDA eventually released the initial information on a settlement with Bristol before the company had even contacted the medical community with its "Dear Doctor" letter.