DDMAC UNTITLED LETTERS.

The following untitled letters were issued by the Center for Drugs Division of Drug Marketing, Advertising and Communications (DDMAC). Copies of these letters are available to subscribers from our RECORD-RETRIEVE Service for $7 plus retrieval. Please reference the MACMIS ID # to order the company response.

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Bayer, West Haven, CT, Oct. 25, 1999 (DDMAC). FDA stated that it had become aware of promotional material for the firm's Baycol (cerivastatin sodium) that it described as misleading because the material implied without substantial evidence that the drug was superior to other HMG CoA reductase inhibitors. The agency stated that the firm's claim that the drug "inhibits cholesterol-producing enzymes in vitro more completely in lower concentrations than any other statin" was misleading because it implied that Baycol was superior to other HMGs based on non-clinical data. The letter stated that the firm's claim regarding increases in high-density lipoprotein coupled with a statement regarding an inverse relationship between HDL-C and the risk of coronary heart disease constitute an unsubstantiated claim regarding effects on morbidity and mortality. A presentation regarding low-density lipoprotein comparing the firm's drug with Pravacol constituted an unsubstantiated claim of superiority. The date of the sales aid was not provided. F-B 

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Dey Labs, Napa, CA, Oct. 6, 1999 (DDMAC). The one-page letter stated simply that a journal advertisement and multi-page brochure for the firm's EpiPen and EpiPen Jr. (epinephrine auto-injectors) lacked fair balance in disclosure of risk information. F-B

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Endo Pharmaceuticals, Garden City, NY, Nov. 24, 1999 (DDMAC). FDA cited the firm's sales aid for Lidoderm (lidocaine patch) for lack of fair balance due to risk information presented in small-sized type at the bottom of selected pages. Fair balance also was seen as problematic because instructions to keep the patch out of the reach of children and pets appeared on the bottom of the last page. The agency stated that the warning failed to "sufficiently convey the importance of this warning and the serious risks this product presents to children." The letter also stated that the sales aid lacked in fair balance due to a failure to disclose important precautions and drug interactions. Among these were cautions regarding contraindications for hepatic disease and patients who are using class 1 anti-arrhythmic drugs. FDA objected to the lack of contextual information with regard to the use of an enriched enrollment study to support claims regarding pain relief. FDA received the sales aid from the firm Oct. 13. F-B

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Fujisawa Healthcare, Deerfield, IL, Nov. 29, 1999 (DDMAC). FDA's review of an ad placed in the Oct., 1999 issue of "The Journal of Nuclear Medicine" found that the firm failed to disclose that Adenoscan was "indicated only for patients who were not able to exercise adequately." The letter stated that the ad failed to present serious side effects associated with the use of Adenoscan with a prominence and readability comparable to the information on drug effectiveness. Information lacking in the ad was said to include contraindications and adverse events including fatal cardiac arrest, sustained ventricular tachycardia and non-fatal myocardial infarction. The firm's Web site was cited as promoting the drug for unapproved uses including use in patients with left bundle branch block. ID # 8429 F-B, Web

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Jones Pharma, St. Louis, MO, Sept. 28, 1999 (DDMAC). The firm's promotional matter for Cytomel, consisting of an accordion-folded file card and a portfolio, was said to suggest that the drug was effective in treating depression when the drug was not approved for this use. A reference to an early clinical response was said to imply that the drug was useful for patients awaiting clinical response to antidepressants in spite of the risk of cardiac arrhythmia. Information concerning side effects and contraindications was not presented with a prominence reasonably comparable to information regarding the drug's effectiveness. Jones submitted the marketing materials on Feb. 16. ID # 7753 F-B

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Hoechst Marion Roussel, Kansas City, MO, Dec. 6, 1999 (DDMAC). The agency reviewed "a piece of homemade promotional labeling (i.e., a Dear Doctor letter)" and cited the firm for unsubstantiated superiority claims. The objectionable claim was that the firm's Allegra was superior to Claritin because the former "provides the patient with a smooth, continuous, 12-hour delivery" of the drug whereas the comparable version of Claritin "delivers the decongestant all at once." The claim also was made that this "dumping" of pseudoephedrine "can exacerbate side effects associated" with the compound. ID # 8268

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Merck, West Point, PA, Dec. 16, 1999 (DDMAC). FDA cited the firm for a pair of homemade promotional pieces spelling out "10 reasons why Vioxx is better than Celebrex" and featuring a poem titled "Vioxx vs. Celebrex." The agency objected to the claim that Vioxx demonstrated a lower incidence of gastroduodenal ulcers than a placebo in spite of a product insert that stated that "the correlation between findings of endoscopic studies and the relative incidence of clinically serious upper GI events... has not been fully established." The letter stated that the claim "your patient's in pain -- they give you their grief; A-Cox-II is the answer for their pain relief" constituted a broad superiority claim to non-steroidal antiinflammatory drugs (NSAIDS) as well as antics and anti-inflammatory therapies, which the agency insisted had not been demonstrated by substantial evidence. FDA also found the claim that Vioxx was stronger and lasted longer than Celebrex was misleading due to lack of substantial evidence. The sales pieces also were cited for failing to list risk information concerning contraindications, warnings, precautions and adverse events. ID #s 8410, 8506 F-B

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G. D. Searle & Co. Skokie, IL, Oct. 6, 1999 (DDMAC). FDA cited the firm for a pair of undated "homemade" promotional pieces regarding the firm's Celebrex (celecoxib). The letter stated that the claim -- "the new standard of care for analgesic and anti-inflammatory therapy in the management of pain" -- for osteoarthritis and rheumatoid arthritis was not backed by substantial evidence. The agency attached the same observation to the claim that the drug was possessed of "superior safety." The letter stated that the implication that Celebrex combined with low aspirin doses was safer than a similar use of Vioxx was unsubstantiated and failed to disclose material facts concerning the drug's use with aspirin. FDA also noted that the sales letters lacked any risk information regarding contraindications, warnings, precautions or adverse events. ID # 8237 F-B

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G. D. Searle & Co. Skokie, IL, Oct. 13, 1999 (DDMAC). The agency's review of two sales aids for the firm's Arthrotec NSAIDS led to a six-point warning letter. The agency objected to the promotional statement, "are you ready for an unselfish NSAIDS therapy?" because the statement failed to accurately convey that the drug contains misoprostal. FDA said the same claim "suggests that Arthrotec is safer or has fewer side effects" than many NSAIDS which had not been demonstrated by substantial evidence. FDA also commented that the product's warnings, contraindications and precautions caused the claim that the drug is unselfish to unduly minimize risks associated with its use. FDA noted that the claim that the drug "significantly reduces the risk of ulceration vs. diclofenac alone" was backed only by a study that was limited to patients over the age of 65 with symptomatic osteoarthritis of the knee and/or a documented history of significant upper GI mucosal damage. FDA commented that material presenting the hypothetical mechanisms of Arthrotec and NSAIDS indicated that those mechanisms were accepted as fact in spite of the firm's disclaimer on the bottom of the page that the mechanism of action of NSAIDS was not completely understood. The promotional material in question was reviewed by the agency on Aug. 6. ID # 8376 F-B

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Schering, Kenilworth, NJ, Oct. 8, 1999 (DDMAC). The letter cited the firm for a "homemade" sales piece touting the firm's Claritin tablets that "made unsubstantiated claims disparaging the safety of a competitive product and an unsupported superiority claim." The sales letter was said to have referred to a case study that was reported in "Lancet" and stated that "there are concerns with cardiotoxicity with Allegra just as there were with its parent compound Seldane." The letter stated that company officials noted that only one individual was identified as having received the promotional letter. ID # 8706 F-B