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CALCIUM CHANNEL BLOCKER PROMOTION FOR REINFARCTION PREVENTION MAY BE SUBJECT OF NEXT FDA ACTION AGAINST UNAPPROVED USES -- FDA's KESSLER TELLS HOUSE HEARING

Executive Summary

Calcium channel blocker promotions for preventing post- myocardial reinfarction may be the next target of FDA's campaign against unapproved indications. FDA Commissioner Kessler told a June 11 hearing before the intergovernmental relations subcommittee of the House Government Operations Committee that those claims are receiving attention from the agency. Kessler told Subcommittee Chairman Weiss (D-N.Y.) that the agency "will not permit the promotion" of calcium channel blockers for the "unapproved use in improving the survival of patients recovering from a heart attack." Approved for treatment of angina and hypertension, calcium channel blockers have not been shown to be beneficial to such post-infarction patients, Kessler pointed out, and those "with pulmonary congestion who were given a calcium channel blocker showed a decrease in survival compared to those patients given a placebo." Calcium channel blockers "have been promoted for [the] unapproved use," Kessler said, and one company has, "in effect, encouraged physicians to substitute calcium channel blockers for beta blockers, a class of drugs that have been shown to improve survival in certain patients who have suffered a heart attack." Kessler did not name the firm being examined for the calcium channel blocker promotions. The major marketers of calcium channel blockers include Marion Merrell Dow (Cardizem), Pfizer (Procardia) and Searle and Knoll (Calan/Isoptin). One company with a new calcium channel blocker entry, Sandoz, reportedly recently has had a visit from FDA investigators. Within the last several weeks, FDA investigators attempted to contact two Sandoz reps at their homes. The reps declined to talk with the investigators and contacted the company. Sandoz says that it has offered to have the sales reps meet with FDA at company headquarters, but that the agency has not recontacted the company. Neither the company nor FDA would disclose the subject of FDA's investigation. Sandoz received approval for DynaCirc (isradipine) from FDA for mild to moderate hypertension on Dec. 20. The company has traded copromotion rights to the drug to Glaxo as part of the deal establishing a co-development agreement for an OTC version of ranitidine. As FDA continues to gear up for more actions against alleged promotional violations, Kessler is establishing "a working group to conduct an agency-wide review of product advertising." The review particularly will determine "how to construct a springboard for action against the inappropriate promotion of medical devices." The Weiss hearing also focused on promotions of unapproved uses of injectable silicone and collagen. In addition, Kessler reported that FDA plans to launch a program to enlist the help of physicians and medical students in reporting "improper or misleading" promotions. Elimination of promotional abuses ultimately "will depend in part on [FDA's] ability to train practicing physicians and medical students to recognize misleading promotional activities, especially those disguised as research or medical education," he noted. Kessler added that physicians "represent an important, currently untapped source of information about forms of promotion that are difficult for FDA to monitor, such as detailing activities." FDA's ad division has indicated its plans to set up an "800" number hotline for physicians to notify the agency of promotional abuses ("The Pink Sheet" April 29, p. 3).
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