SCIENTIFIC INTERCHANGE ACTIVITIES SHOULD BE HANDLED BY MEDICAL AND SCIENTIFIC SECTIONS IN FIRMS: FDA SAYS SALES OR PR PARTICIPATION MAKES EVENTS PROMOTIONAL

Scientific/educational seminars and publications will be regulated as advertising and promotion by FDA if the sales, marketing or public relations departments of drug companies are involved in the planning or control of the events. According to FDA's developing "scientific interchange" policy, the participation of individuals from sales, marketing or public relations will be one of the key determinants to help FDA decide whether an event is educational or promotional in nature. If FDA is convinced that a program is an independent educational event, then the agency will permit it to be conducted under a "limited exception" to its standard advertising and promotional controls. One of the fundamental objectives of the agency's new policy appears to be to make company-sponsored educational events the sole province of corporate medical and scientific departments and to root out all affiliations with sales, marketing or public relations departments. The agency's nascent policy statement on the "Regulation of Drug-Company Sponsored Activities in Scientific or Educational Contexts" specifically states at least six times that if a company's sales, marketing or public affairs staffers participate in the design or control of a program then it will be considered a promotional event. To qualify as an "independent" program, for example, the sponsoring drug company must make sure that all "liaison" with the provider organization (the group running the event) is handled by the sponsor's scientific and medical departments. A recent draft of the proposed policy statement declares that "individuals who are involved in the sponsor's promotional, sales, marketing, or public relations activities, even if employed in the medical or scientific departments, [must] play no role in planning, organizing, or carrying out the sponsored activity." Similarly, the sponsor must agree to refrain from having ancillary promotional activities attached to the educational event. The sponsor must agree, FDA proposes, "not to have any promotional activities in proximity to the educational activity, such as participation by sales representatives, nearby promotional exhibits, or advertisements in any printed materials disseminated in the program." The promotional arms of drug companies must also be kept out the process of selecting and inviting the audience to a meeting. "Invitation or mailing lists for sponsored activities" should not be "generated by the sales or marketing departments of the sponsor nor are they intended to reflect sales or marketing goals (e.g., to reward high prescribers or the sponsor's products, or to influence 'opinion leaders')." This part of the proposed policy statement jibes with positions that FDA has recently taken in one- on-one negotiations with companies regarding promotional practices. FDA previously has told Bristol Labs that it cannot use its sales force to distribute invitations to educational seminars sponsored by the company in the oncology area ("The Pink Sheet" Sept. 30, p. 8). The restriction was specified as an outgrowth of the company's settlement in June on alleged violations of promotional practices in the oncology area. To FDA, the issue in differentiating between scientific interchange and promotion is the effect of the program on sales of a product or a company's products. FDA explains that it "has avoided" a simple attempt to delineate "between promotion on the one hand and scientific education on the other." The "key distinction" for the agency's purposes "is whether or not the sponsor has influenced the content of the scientific or educational activity to promote sales of its product." FDA's structural approach to the "scientific interchange" guidelines is to describe several sets of standards (for "independence," "objectivity and balance," and "format") which, if followed, should qualify a program or publication for a lesser degree of FDA oversight. [EDITORS' NOTE: See next page for the "standards" on independence described by FDA in its draft policy statement.] "If the standards in the proposed policy are met," FDA writes, the agency "generally will not infer promotional intent in a drug company-sponsored activity and will refrain from regulatory action under the labeling and advertising provisions of the Act." The agency uses the qualifier "generally" because it reserves the right to step in to regulate an activity after-the-fact if it finds that an event has taken on a promotional aspect. The agency notes four situations in which it will move to regulate events which may have met all of the standards for an educational program. FDA says "it may consider the following factors with regard to the issue of promotional intent": (1) frequently-held discussions of unapproved uses that reflect "an intent to create demand"; (2) repeated dissemination of promotional material derived from an educational activity; (3) actual evidence of promotional intent ("e.g., company memoranda or complaints from the provider about attempts to influence content"); and (4) exclusive focus on a single product in a class of related compounds. FDA also wants to make the the sponsors of educational events de facto policemen with the responsibility for assuring that the message from a conference does not violate a promotional restriction. "The sponsor's responsibility does not end with the planning of the activity," FDA declares. The sponsor should "monitor the program to ensure that it does not provide misleading information regarding the sponsor's products." If "after the activity," the sponsoring firm discovers that the activity "contained false or misleading information about its products," then the firm "should take corrective action." FDA defines corrective action as withdrawing support and/or providing corrective, truthful information after the program. In FDA's view the "paradigm" of an educational activity sponsored by drug companies would be an event that "(1) is sponsored by a number of drug companies that market competing products, and whose interests in the topic that is the focus of the activity do not coincide, and (2) the sponsors commit to funding without knowing the topics to be discussed." The agency acknowledges, however, that the "paradigm will rarely be followed." The standards for independence that it is preparing are for "sole-sponsored" events where the sponsor "may be aware of the general topic before deciding to fund the activity." "STANDARDS" FOR INDEPENDENCE OF EDUCATIONAL EVENTS -- FROM FDA DRAFT PROPOSAL Excerpted by "The Pink Sheet" from a draft of FDA's proposed policy statement for regulating educational activities supported by drug companies. The proposal would apply to seminars, publications, medically-oriented TV programs, educational videotapes, software and slide kits. The agency specifies standards for "objectivity and balance," "scientific rigor" and "format" as well. The independence standards are printed here to provide an example of the type of material in the policy statement. FDA has not completed the policy statement for official public release. Drafts of the document, however, have been circulating in Washington. The agency had hoped to release a first draft in mid- October to allow for development of a final statement by the end of this year. The polished quality of the draft from which these sections are taken indicates that the agency is close to meeting its schedule. Currently, the proposal is expected out before the beginning of November. INDEPENDENCE (i) Selection of provider. The extent of the financial relationship between the sponsor and the provider is not such that the sponsor appears to be in a position to exert influence over the content of the activity through the provider. Individuals involved in advising or otherwise assisting the sponsor with respect to sales or marketing of the sponsor's products are not involved in independent or educational activities. (ii) Independent experts. The sponsor plays no role in the selection of presenters or authors. The provider agrees to avoid significant participation by experts who have ongoing financial relationships with the sponsor. If such experts are included in the activity at all, their recent and current relationships to the sponsor must be disclosed. (iii) Disclosure of financial relationships. The provider agrees to provide for meaningful disclosure to the target audience of the actual source of funding for the activity by the sponsor, and of pre-existing relationships between the provider and the sponsor and between individual presenters and the sponsor. (iv) Topic. The focus of the activity is on broad aspects of a disease and on a variety of treatments. The focus is not a specific drug product marketed by the sponsor or a competing drug product. (v) Single performance. Live scientific activities, e.g., symposia, are ordinarily not repeated. Thus, live presentations should not be the same as, or similar to, a previously sponsored program, enabling the sponsor to judge content and to support continued presentations of programs favorable to its product without adherence to the rules for promotional activities. (vi) Sponsor involvement. The sponsor agrees not to engage in any activities, including scripting, ghost-writing of papers, preparation of audiovisual aids, training of presenters, or targeting of points for emphasis, that might influence the choice or treatment of topics. (vii) Ancillary promotional activities. The sponsor agrees not to have any promotional activities in proximity to the educational activity, such as participation by sales representatives, nearby promotional exhibits, or advertisements in any printed materials disseminated in the program. This does not prohibit the required acknowledgement of the sponsor's support for the activity. (viii) Liaison. Liaison with provider is through the sponsor's medical or scientific departments, and specifically by individuals with appropriate scientific or medical training, experience and responsibilities within the firm. Individuals who are involved in the sponsor's promotional, sales, marketing, or public relations activities, even if employed in the medical or scientific departments, play no role in planning, organizing, or carrying out the sponsored activity.