UNITED STATES OF AMERICA
In the Matter of DOCKET NO. 9279 FINAL ORDER For purposes of this order 1. "Doan's" shall mean any over-the-counter analgesic drug, as "drug" is defined in the Â鶹´«Ã½ Trade Commission Act, bearing the Doan's brand name, including, but not limited to, Regular Strength Doan's analgesic, Extra Strength Doan's analgesic, and Extra Strength Doan's P.M. analgesic. 2. "Competent and reliable scientific evidence" shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. 3. "Advertisement" shall mean any written, oral or electronic statement, illustration or depiction which is designed to create interest in the purchasing of, impart information about the attitudes of, publicize the availability of, or affect the sale or use of goods or services, whether it appears in a brochure, newspaper, magazine, free standing insert, marketing kit, leaflet, circular, mailer, book insert, letter, catalogue, poster, chart, billboard, public transit card, point-of-purchase display, package insert, package label, product instructions, electronic mail, website, homepage, film, slide, radio, television, cable television, program-length commercial or "infomercial," or in any other medium. I. IT IS ORDERED that respondents Novartis Corporation, and Novartis Consumer Health, Inc., corporations, their successors and assigns, and their officers, agents, representatives and employees, directly or through any corporation, subsidiary, division or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of Doan's or any other over-the-counter analgesic drug, in or affecting commerce, as "drug" and "commerce" are defined in the Â鶹´«Ã½ Trade Commission Act, do forthwith cease and desist from representing, in any manner, directly or by implication, that such product is more effective than other over-the-counter analgesic drugs for relieving back pain or any other particular kind of pain, unless, at the time of making such representation, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation. For purposes of Part I of this Order, "competent and reliable scientific evidence" shall include at least two adequate and well-controlled, double-blinded clinical studies which conform to acceptable designs and protocols and are conducted by different persons, each of whom is qualified by training and experience to conduct such studies, independently of each other. II. IT IS FURTHER ORDERED that respondents Novartis Corporation, and Novartis Consumer Health, Inc., corporations, their successors and assigns, and their officers, agents, representatives and employees, directly or through any corporation, subsidiary, division or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sales or distribution of Doan's or any over-the-counter analgesic drugs in or affecting commerce, as "drug" and "commerce" are defined in the Â鶹´«Ã½ Trade Commission Act, do forthwith cease and desist from making any representation, in any manner, directly or by implication, regarding such product's efficacy, safety, benefits, or performance, unless, at the time of making such representation, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation. III. Nothing in this Order shall prohibit respondents from making any representation for any drug that is permitted in labeling for any such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration. IV. IT IS FURTHER ORDERED that respondents Novartis Corporation, and Novartis Consumer Health, Inc., corporations, their successors and assigns, and their officers, agents, representatives, and employees, directly or through any corporation, subsidiary, division or any device, do forthwith cease and desist from disseminating or causing the dissemination of any advertisement for Doan's in or affecting commerce, as "commerce" is defined in the Â鶹´«Ã½ Trade Commission Act, unless the advertising includes the following corrective notice, clearly and prominently, in the exact language that follows: "Although Doan's is an effective pain reliever, there is no evidence that Doan's is more effective than other pain relievers for back pain." Provided, that respondents' obligation to include the corrective notice shall not be required for any television or radio advertisement of 15 seconds or less in duration. Provided further, that respondents' obligation to include the corrective notice in all advertising shall continue for one year and until respondent has expended on Doan's advertising a sum equal to the average spent annually during the eight years of the challenged campaign. V. IT IS FURTHER ORDERED that for a period of five (5) years after the last date of dissemination of any representation covered by this Order, respondents or their successors and assigns, shall maintain and upon request make available to the Â鶹´«Ã½ Trade Commission for inspection and copying:
VI. IT IS FURTHER ORDERED that respondents shall:
VII. IT IS FURTHER ORDERED that respondents shall notify the Commission at least thirty (30) days prior to any proposed change in their corporate structures, including, but not limited to, dissolution, assignment, or sale resulting in the emergence of a successor corporation, the creation or dissolution of subsidiaries or affiliates, or any other corporate change that may affect compliance obligations arising out of this Order. VIII. IT IS FURTHER ORDERED that this Order will terminate twenty (20) years from the date this Order becomes effective, or twenty (20) years from the most recent date that the United States or the Â鶹´«Ã½ Trade Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the Order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of:
Provided further, that if such complaint is dismissed or a federal court rules that the respondents did not violate any provision of the Order, and the dismissal or ruling is either not appealed or upheld on appeal, then the Order will terminate according to this Paragraph as though the complaint was never filed, except that the Order will not terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling, and the date such dismissal or ruling is upheld on appeal. IX. IT IS FURTHER ORDERED that respondents shall, within sixty (60) days from the date this Order becomes effective, and at such other times as the Â鶹´«Ã½ Trade Commission may require, file with the Commission a report, in writing, setting forth in detail the manner and form in which they have complied with this Order. By the Commission. Attachments: |