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HOECHST-ROUSSEL’s LASIX PROMOTIONS TARGETED IN FDA WARNING LETTER: FIRM TOLD TO ISSUE "DEAR DOCTOR" LETTER CORRECTING SUPERIORITY CLAIM OVER GENERICS

Executive Summary

Hoechst must correct violative claims of therapeutic superiority for its Lasix (furosemide) loop diuretic product with a "Dear Doctor" letter delivered via direct mail and paid ads in 12 medical journals, FDA says in a June 24 warning letter to the firm. "Based on materials we reviewed as part of our monitoring program, we have determined that many of Hoechst's advertising and promotional materials for Lasix contain false and misleading claims and assertions in violation of the [FD&C Act]," the warning letter says. Specifically, Hoechst "alleges that its product is superior and that switching to or between generic furosemide products could produce undesirable outcomes," FDA said. "However, there is no evidence to substantiate these claims." FDA pointed out that all approved furosemide oral tablets are "AB"-rated or therapeutically equivalent to each other and appropriate for substitution. The letter was signed by Division of Drug Marketing, Advertising and Communications Acting Director Cheryl Fossum Graham, MD. Because of the "repetitive nature of Hoechst's violative conduct, prompt remedial action to correct these violations is necessary," the warning letter says. The agency has asked the company to "prepare a 'Dear Doctor' letter informing physicians of the violative nature of Hoechst's promotional activities and correcting any resulting misconceptions." After being approved by the ad division, "the letter is to be disseminated both by direct mail and through a paid advertisement in the 12 medical journals having the greatest U.S. circulation." According to the letter, Hoechst's promotional campaign for Lasix includes statements to the effect that "'use of generic dosage forms and chemically equivalent drug products may, in individual patients produce erratic results, even though large- scale deviations in therapeutic outcomes have not yet been documented.'" Other materials cited in the warning letter state: "'If you don't take the steps required by your state law to prevent substitution, these patients may not be receiving the critical care they need.'" The promotional materials singled out by FDA include a journal ad with the heading "Elderly patients can be more sensitive...," ads stating that "Mandatory substitution is not recommended...," and a file card saying "Keep CHF patients in the Winner's Circle...." In a prepared statement, Hoechst said: "While Hoechst-Roussel believes the advertising is supportable, it intends to work with the FDA to resolve the agency's concerns." The company declined to elaborate further on its communications with FDA. The warning letter pointed out that Hoechst's superiority claims are "not novel" and that they "have been a recurring theme in Hoechst's promotion of Lasix." FDA noted that it sent a letter to Hoechst in January 1986 concerning a promotional campaign for Lasix. In the 1986 letter, FDA said that "'this ad suggests that substitution of generic furosemide products for your brand Lasix may result in...'profound consequences' or decompensation in patients with CHF.'" The agency added that "'to suggest that use of these products will result in adverse clinical effects or therapeutic failure is not acceptable unless you have data to support such claims.'" In the June letter, FDA also requested that the company "cease immediately the use of any and all aspects of its advertising and promotional campaign that are violative." The agency also wants Hoechst's plans for corrective actions, including directions to sales reps and "a complete listing" of advertising and promotional materials that are currently in use and those which will be discontinued. Some of the Lasix materials have information that "compares the price of Lasix to that of generic furosemide and that of Bumex (bumetamide)," the warning letter says. Bumex is a loop diuretic made by Roche. "Hoechst makes claims based on this comparison; however, no data has been submitted to show how the prices cited were derived."

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