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Executive Summary

WHITEHALL's PREPARATION H DATA ARE INADEQUATE to support the OTC product's use for relief of hemorrhoidal symptoms and no data exist on its effectiveness in shrinking hemorrhoids, FDA said in a March 5 letter to the firm. American Home Products' Whitehall Labs operation is attempting to get the active ingredient in Preparation H and Wyanoids suppositories, live yeast cell derivative (LYCD), included in the rulemaking for OTC anorectal drugs. FDA "has evaluated the two studies (WBI-1987 and WM-444B) for anorectal use and finds that they are unacceptable to demonstrate the effectiveness of LYCD for relief of hemorrhoidal symptoms of pain, itching, burning or irritation," the agency letter states. It adds that "the studies do not contain data to support the claim concerning shrinking swelling of hemorrhoidal tissue caused by inflammation." The double-blind, randomized clinical trials compared an ointment containing 2,000 units per ounce of LYCD with an ointment containing no LYCD in the relief of hemorrhoidal discomfort ("The Pink Sheet" Aug. 28, 1989, T&G-11). The agency said that the conduct of the studies "was independently inspected by agency field investigators who found evidence of unreliability of the data submitted on behalf of your company." Preparation-H is the largest-selling OTC hemorrhoidal product in the U.S.: 1990 sales were $71 mil. (worldwide). The company said sales increased in 1991. FDA noted that in a Nov. 13, 1991 letter, Division of Scientific Investigations Director Frances Kelsey, MD/PhD, informed the investigator for study WBI-1987 that "the study had serious deficiencies and significant departures from commonly accepted investigational practices." The deficiencies included "protocol violations, inadequate drug accountability records, unexplained subject writing similarities, and incomplete information on informed consent forms." FDA also "determined that several patients were used twice in this study." In his response letter, FDA noted, the study's investigator said that the sponsor "did not come to the test site to check drug, supply drug accountability or disposition records and did not come to monitor the progress of the study or case report forms." With the other study, WM-444B, FDA maintained that "there is no way to determine from your data if the dispenser or subject had knowledge of the nature of the ointment used when the efficacy of the ointment was evaluated." FDA also questioned whether one of the study investigators, a non-physician, was qualified to treat and evaluate patients. FDA said that it will respond to the data in an upcoming Federal Register notice on the anorectal rulemaking. In the final rule for OTC anorectal products, published in August 1990, the agency deferred a final decision on the status of LYCD pending review of the two clinical studies ("The Pink Sheet" Aug. 6, 1990, p. 14). LYCD was Category III in the anorectal tentative final monograph. In its March 5 letter, FDA said that should Whitehall Labs accrue new data following the Federal Register notice, the firm can file a citizen petition to amend the monograph to include LYCD or it can file an NDA.

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