HOECHST-ROUSSEL CORRECTIVE ADS FOR LASIX PROMOTIONS

HOECHST-ROUSSEL CORRECTIVE ADS FOR LASIX PROMOTIONS are running in January issues of 10 medical and pharmacy journals. FDA requested the corrective ads in a June 24 warning letter that cited Hoechst-Roussel Pharmaceuticals, Inc. for making superiority claims for the loop diuretic Lasix (furosemide) over generics ("The Pink Sheet" July 13, 1992, p. 8). The ad, in the form of a "Dear Doctor"/"Dear Pharmacist" letter from VP-Sales and Marketing Gerald McMurtry outlines the three advertising and promotional "statements and implications" cited by FDA as false: "that the use of generic dosage forms and chemically equivalent drug products may, in individual patients, produce erratic results"; that "certain patients who receive generic furosemide in substitution for Lasix may not be receiving the care they need"; and "that Lasix is superior to generic furosemide products." In addition, the corrective ad notes that approved generic furosemide dosage forms are "AB" rated and therefore therapeutically equivalent and appropriate for substitution. FDA's warning letter asked that "Dear Doctor" letters be sent out via direct mail and corrective ads appear in the 12 medical and pharmacy journals with the greatest circulation. Although FDA has not yet issued a formal closing letter saying that all outstanding issues regarding the ads have been resolved, Hoechst says it has fulfilled FDA's requirements for corrective action. No direct mail letters were sent out by the company. ICI's Stuart Pharmaceuticals division sent out "Dear Doctor" letters Dec. 21 to 112,000 primary care physicians and cardiologists regarding advertising and promotion of the ACE inhibitor Zestril (lisinopril). FDA called for the correction in a March 2 warning letter ("The Pink Sheet" March 23, 1992, p. 12). Also in the warning letter, the agency imposed a preclearance requirement for promotional materials for a period of six months. ICI said it has been submitting materials to FDA since March and is unsure whether that requirement will now be lifted or will be continued for the six-month period following the issuance of the "Dear Doctor" letter. ICI's "Dear Doctor" letter, signed by Stuart Associate Director-Professional Communications Nancy Nazari, states that "FDA has expressed concern that, in its view, the campaign made comparisons between the dosage schedules of Zestril and other ACE inhibitors based solely on the information contained in the labeling (package inserts) for the various products. This comparison is not intended to suggest that Zestril is more effective than other ACE inhibitors. Such comparisons of effectiveness or duration of action can only be made upon adequate and well-controlled studies directly comparing Zestril with other ACE inhibitors utilizing their full dosage range." In addition, the warning letter says: "In [FDA's] view, the Stuart promotion suggested a correlation between Zestril treatment and the reduction in incidence of silent stroke and left ventricular hypertrophy. Specifically, the promotional materials cited a study of 30 patients demonstrating a correlation between 24-hour blood pressure load and left ventricular mass as evidence of LVH. This was followed by a study of 35 patients reporting the effect of Zestril on blood pressure load. We would like to reemphasize that these studies do not establish that a correlation exists between BP load reduction with Zestril, or any other antihypertensive treatment, and prevention or reversal of target organ damage." The warning letter adds that use of Zestril's name in the firm's materials on the mechanism of heart failure "suggests that Zestril is valuable in the treatment of heart failure" although it is not indicated for that use, "unlike other ACE inhibitors." In addition, the warning letter cites suggestions in promotional materials that Zestril is superior to other treatments in the area of hypertension and mortality when "lisinopril has never been studied in that setting." These two issues are not addressed in ICI's "Dear Doctor" letter. FDA's Cardio-Renal Drugs Advisory committee will consider a CHF indication for lisinopril at a Feb. 18-19 meeting. Two 1992 promotional warning letters remain unresolved: Upjohn for Glynase Prestab tablets and Marion Merrell Dow for Carafate. Upjohn has not yet resolved issues raised in a Nov. 25 warning letter regarding promotions of its Glynase Prestab tablets ("The Pink Sheet" Dec. 7, 1992, p. 3). Marion Merrell Dow is in continuing discussions with FDA on "how to communicate and what to say" in the proposed "Dear Doctor" letter for the ulcer drug Carafate ("The Pink Sheet" Oct. 26, 1992, p. 8). MMD expects a resolution may occur within a month or so.