TELEPHONE Rx DRUG ADS: SIDE EFFECT INFORMATION MUST BE "INTEGRAL PART"

TELEPHONE Rx DRUG ADS: SIDE EFFECT INFORMATION MUST BE "INTEGRAL PART" of the telephone communication, FDA Drug Marketing, Advertising and Communications Division Acting Director Janet Rose said in an Aug. 6 letter to industry. FDA requires a "major statement" of serious side effects and contraindications in broadcast advertisements that include product-specific information, Rose noted. Noting that "telephone communication technology allows a listener to 'branch' to selected segments of a presentation," Rose said that "in order for the major statement to be considered an integral part of the telephone communication, it must be presented either in every 'branch' segment of the original call or in an introductory segment prior to any 'branching' decision point." "A recent survey of toll-free telephone numbers contained in prescription drug advertising revealed that, in many cases, the information conveyed by telephone violated FDA regulations," Rose wrote. "Therefore, this letter is being issued to clarify the regulatory status of professional and consumer prescription drug advertising via the medium of telephone communications." Product specific telephone ads must include "a procedure, integral to the communication, for ensuring that listeners will have the product's approved labeling mailed first class or faxed to them within two business days," Rose said. Without such a procedure, the ads must include a brief summary "as an integral part of the telephone communication." The letter also addresses advertisements that solicit telephone inquiries. While reminder ads are exempt from the requirement to include a brief summary, Rose added that "the intent of the exemption is undermined when readers are solicited to call a telephone number that conveys product-specific information." Under these circumstances, the letter continues, "the telephone advertisement resulting from a reminder solicitation must contain the major statement" and either provide labeling for the caller or include a brief summary. "In the absence of these, both the telephone and the soliciting print advertisement will be considered to be violative product-specific advertisements," Rose warned. The letter notes that so-called "help-seeking" ads that solicit telephone inquiries about a specific disease without mentioning a product are not normally regulated as prescription drug ads. "However, should a manufacturer deliver product-specific information in a telephone communication that is solicited through a help-seeking advertisement, FDA will consider the soliciting advertisement to be a prescription drug advertisement and will regulate it as such," the letter states. "Maintenance of the help- seeking status of a soliciting advertisement requires that any product-specific information disseminated be at least one step removed from the initial solicited request for information." "Regardless of target audience, at the time of initial use, copies of the telephone recordings and scripts, and a description of branching patterns, must be submitted to DDMAC," the letter adds. "In addition, as with all direct-to-consumer advertisements, we encourage firms to submit to DDMAC for pre-clearance draft scripts of telephone communications aimed at consumers and soliciting print or broadcast advertisements."