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WYETH-AYERST CORDARONE "DEAR DOCTOR" CORRECTIVE LETTER GOING TO OVER 18,000 MDs; INTERNAL COMMITTEE FORMED TO REVIEW FUTURE PRODUCT PROMOTIONS

Executive Summary

Wyeth-Ayerst is mailing over 18,000 copies of a "Dear Doctor" corrective letter for its anti-arrhythmic Cordarone (amiodarone HCl). Addressed to 14,987 cardiologists and 3,165 internists who also specialize in cardiology, the letter is designed to "correct possible misconceptions" fostered by the company's professional journal ads for Cordarone. Signed by Wyeth-Ayerst VP-Medical Affairs and Medical Director Mark Deitch, MD, the letter states: "Contrary to what our promotion may have implied, Cordarone is an agent of last resort." Any decision to use Cordarone," the letter states, "should be based on a thorough analysis of alternative therapy and risk/benefit, undertaken by a physician who is expert in the treatment of ventricular arrhythmias." The company is including full prescribing information in the mailing and calling attention to the labeling with a headline -- " Important Correction of Drug Information" The 18,152 "Dear Doctor" letters are being sent to physicians who received Cordarone promotional materials during 1988-89. The letter is a partial response from Wyeth-Ayerst to a Dec. 15 regulatory letter that asked the firm to review the scientific basis of every prescription drug marketed by the firm ("The Pink Sheet" Jan. 1, p. 10). The reg letter, from FDA Office of Drug Standards Director Peter Rheinstein, MD, called Wyeth-Ayerst's record of compliance with FDA standards for drug promotions "intolerable." FDA specifically identified the company's promotions for Cordarone and the transdermal nitroglycerin patch Deponit. * In addition to the Cordarone corrective letter, Wyeth-Ayerst agreed at a Feb. 8 meeting with FDA that it will preclear all Cordarone promotional materials for a period of six months. At the meeting, according to an FDA memorandum, Wyeth-Ayerst was represented by Deitch, VP-Regulatory Affairs & Project Planning Joseph Bathish, Senior VP-Marketing, Professional Products Martin Meaney, VP-Sales and Marketing Robert Essner, Director-Legal Division Charles Ross and Washington, D.C. attorney William Vodra (Arnold & Porter). FDA representatives at the meeting included Rheinstein, Division of Drug Advertising and Labeling Acting Director Ken Feather, David Adams from the General Counsel's Office, and David Banks from the division of Drug Advertising and Labeling. Prior to the meeting, in a Jan. 12 letter to Feather, Wyeth-Ayerst's Bathish outlined the company's initial reaction to the reg letter. He pointed out that the company had agreed to plan no direct mail or physician detailing by office-based sales reps for Cordarone until the company had "reached a mutual resolution on the acceptable promotion" of the drug. Wyeth-Ayerst's hospital-based sales reps, Bathish promised, would "maintain a dialogue" with cardiovascular specialists and would not hand out any written promotional materials cited by FDA in the reg letter. Wyeth-Ayerst has since instituted an internal oversight process, which includes a promotional materials review committee, in order to head off future problems with promotional practices. The company described the committee as having "appropriate expertise and empowerment to prevent violative promotional activities," according to the agency memo-of-meeting. The Wyeth-Ayerst internal committee includes marketing, medical, legal and regulatory affairs personnel, the company said. To show good faith, Wyeth presented FDAers at the Feb. 8 meeting with materials from "a small group" of then-current promotions for other Wyeth-Ayerst drug products that were pulled by the firm due to "inadequacy of supporting data for claims presented," FDA said. At the meeting, FDA also requested formulation and bioequivalence data on Inderal LA (sustained release propanolol) "relative to the sustained-action formulation marketing in the U.K." In promotional materials that appeared in U.S. professional journals, the company referenced a version of Inderal LA used in U.K. clinical trials. Those ads presumably related the efficacy of Inderal LA with the generic version marketed by Forest Labs' Inwood Labs subsidiary. Inwood, which currently is the exclusive marketer of the only generic version of sustained-release, propanolol, and Wyeth-Ayerst are currently engaged in a dispute over the basis of Inwood Labs' bioequivalence data. Inwood recently defended the equivalency conclusions of its bio studies in a March 9 submission to FDA ("The Pink Sheet" March 19, T&G-4). The dispute began with a Feb. 13 citizens petition from Wyeth-Ayerst ("The Pink Sheet" Feb. 26, T&G-1). * Regarding Deponit, Wyeth-Ayerst's Bathish informed the agency that the transdermal nitroglycerin patch has been owned by the Kremers Urban division of Schwarz Pharma since Jan. 4, 1990. The two firms' marketing and distribution arrangement for Deponit actually began in August of 1989, Bathish noted. At the time on Oct. 3, 1989 when Wyeth submitted the problematic promos, the company told FDA that it "was acting only as a 'mail drop' for Schwarz Kremers promotional materials until transfer of official responsibility for the new drug application to Schwarz Kremers was effected." FDA's Dec. 15 reg letter cited Wyeth-Ayerst for conducting false and/or misleading promotional activities for Deponit. These included the distribution of brochures highlighting favorable efficacy claims that were derived from an uncontrolled study conducted by Wyeth-Ayerst. Wyeth described its participation in the Deponit promos as "limited," according to the memo-of-meeting. Wyeth said that its limited participation consisted of conducting the uncontrolled studies used, passing the study the study along to Kremers Urban along with "prior promotional pieces" and serving as a "conduit for submission of Deponit promotional materials." Kremers Urban agreed to discontinue the promotion in question and to comply with FDA requests about future promos. In its memo to the agency, Wyeth-Ayerst acknowledged that "it might have been appropriate...to have shared with Schwarz Kremers" the agency's "concerns regarding promotional uses of uncontrolled studies." Wyeth-Ayerst noted that it had been informed of FDA's views "shortly before" the company relinquished the application for Deponit. Wyeth-Ayerst's problems with FDA apparently will continue. At the Feb. 8 meeting, FDA informed the company that some current company promo tions were "of concern" to the agency for the same reasons Cordarone and Deponit incurred FDA scrutiny. The agency's memo did not identify the products. However, FDA said "As a background, our regulatory letter to the firm focused upon the two basic issues of promotion of unapproved uses and scientific legitimacy of promotional claims." The memo says FDA requested that Wyeth-Ayerst "specifically assure scientific legitimacy of current promotional activities."
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