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Executive Summary

A special prescription drug advertising supplement that ran in Time magazine's June 27 issue is being reviewed by Rep. Dingell (D-Mich.) and the staff of his House Commerce/Oversight Subcommittee. In a July 14 letter to FDA Commissioner Young, Dingell requested documents and memoranda in agency files "relating to the special advertising section in the recent Time magazine, the advertisements contained therein, or any discussion or analysis regarding those advertisements." FDA and Dingell reportedly have concerns with a Genentech advertisement included in the supplement. The ad carries the headline, "New therapies are available which may stop a heart attack in progress" and was one of three ads in the supplement ("The Pink Sheet" July 4, T&G-1). Noting that "most heart attacks are caused by a blood clot," the ad states that "new therapies can dissolve the clot, restoring blood flow -- and saving the heart." The promotion bears the logos of the American Heart Association and Genentech, although fine print at the bottom of the page points out that the space was paid for by the company. It makes no reference to Activase, alteplase or TPA. However, it is followed by an article that is entitled "Future Drug Therapies" and states: "A new drug, tissue plasminogen activator (TPA), which can unclog coronary arteries, was developed using DNA technology." The article does not mention the TPA competitor streptokinase. FDA's biologics staff is reviewing the ad and Time's special supplement. Because TPA is a biological, regulatory jurisdiction for the ad lies with FDA's Office of Biologics Research and Review. Genentech says it precleared the ad with FDA's biologics staff; however, the ad may have been submitted as part of a package of TPA promotional materials and may not have been reviewed in the context of the magazine supplement. The articles were written by Anne Mattarella, executive editor of Medical Times and Resident & Staff Physician. John Grisso and Randy Shields are listed as "pharmaceutical industry consultants." The the top of each page of copy bears the logo, "SPECIAL ADVERTISING SECTION." Of the three ads in the supplement, only a Sandoz ad for Sandimmune was precleared by the Rx Advertising & Labeling Division. In a meeting with FDA's Rx Drug Advertising & Labeling Division, the subcommittee staff reportedly expressed concerns that the articles constitute product promotion. However, absent evidence that the articles themselves were written, influenced, or paid for by the industry, FDA says it will maintain a hands-off attitude. Dingell reportedly also considers an ad sponsored by Ortho to be product-specific. The ad is entitled "Should You Take a Break from the Pill?" and is identified in fine print as "a message from the Association of Reproductive Health Professionals through an educational grant from Ortho." The congressman is said to be curious as to whether the ad is indeed a message from health professionals or a promotion by the company.

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