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Executive Summary

MAALOX HRF HEARTBURN RELIEF FORMULA ANTI-REFLUX CLAIMS DRAW WARNING LETTER from FDA. The Sept. 1 warning letter from FDA Drug Labeling Compliance Division Director Richard Chastonay cites promotional statements made by Maalox manufacturer Rhone-Poulenc Rorer describing the product as an esophageal reflux treatment. "Such claims are not permitted under [the] labeling provisions of the [OTC] antacid monograph, and are therefore unacceptable advertising conditions," the letter states. FDA pointed to several statements included by Rhone-Poulenc Rorer in letters introducing the product to physicians and pharmacists. The company letters state: "Rhone-Poulenc Rorer is pleased to announce a new addition to the Maalox family of products....Maalox HRF specifically designed to treat patients who suffer from reflux." In addition, the RPR letters imply that Maalox HRF may "mitigate" asthmatic conditions "by mentioning that reflux can exacerbate asthmatic conditions," FDA asserted. The agency warning letter comes seven months after RPR officially launched a $15 mil. consumer and professional advertising and promotional campaign for the new formulation of Maalox ("The Pink Sheet" Feb. 17, In Brief). The campaign included TV spots and coupons, as well as medical and trade promotions. Objecting to the advertising for Maalox HRF, FDA said that statements such as "'New for reflux....Introducing Maalox HRF Heartburn Relief Formula. Effective relief for reflux.... Recommend Maalox HRF'...represent and suggest that Maalox HRF is made with a unique formula that is intended to be used for the treatment and prevention of reflux." In addition, FDA noted that the shoulder label (around the neck of the bottle) for Maalox HRF reads: "a new patented formula that works two ways: it relieves burning acid indigestion fast and controls stomach acid to protect you from acid-induced heartburn." RPR's claims that Maalox HRF is a patented formula for reflux "represent and suggest that the product is capable of providing the same benefits and in the same manner as an antacid that acts by 'floating' on the stomach contents," FDA maintained. "Any OTC antacid making such representations and suggestions is a new drug requiring an approved NDA," the agency said. Marion Merrell Dow has long promoted its OTC antacid Gaviscon as containing an ingredient, alginic acid, which converts to sodium alginate and floats on top of stomach contents to prevent acid reflux. MMD stepped up its promotional activities for Gaviscon in February, around the same time that RPR's Maalox HRF ad campaign broke, highlighting the "barrier" to reflux claim ("The Pink Sheet" Feb. 24, T&G-2). Gaviscon was approved via an NDA in 1987. In the warning letter, FDA also raised questions about certain Maalox HRF ingredients. The agency noted that two of the inactive ingredients in the product, calcium carbonate and potassium bicarbonate, "also have recognition as active antacid ingredients." Because the two ingredients also are recognized as active antacid ingredients, FDA said there is a "question whether these two components are fully acceptable as inactive ingredients." Maalox HRF lists as active ingredients aluminum hydroxide-magnesium carbonate codried gel 280 mg and magnesium carbonate USP 350 mg. RPR said it has responded to the FDA warning letter and believes that its promotions for Maalox HRF are consistent with the OTC monograph for antacid products. The company maintained the claim that Maalox HRF is effective in the treatment of heartburn caused by reflux is appropriate and that RPR does not promote the product as prevention against acid reflux.

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