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CONJUGATED ESTROGENS DATA MISPLACED AT FDA FOR THREE-MONTHS, CDER's PECK TELLS REP. DINGELL; LOST DATA FROM WYETH-AYERST, DURAMED, ZENITH DELAYS FDA ACTION

Executive Summary

FDA misplaced for three months data on conjugated estrogens submitted by Premarin- manufacturer Wyeth-Ayerst and two generic firms, Duramed and Zenith, FDA Center for Drug Evaluation and Research Director Carl Peck, MD, acknowledged in a Dec. 26 letter to Rep. Dingell (D-Mich.). Data from the firms "were misplaced in Dr. Bilstad's and Dr. Burlington's outer office" from Aug. 11 to Nov. 1, 1990, Peck told Dingell. James Bilstad, MD, directs FDA's Office of Drug Evaluation II and Bruce Burlington, MD, was then acting director of the Office of Generic Drugs. Peck described the three months in question as a "period of concern" in FDA's handling of the conjugated estrogens issue. Peck was responding to Dingell's Nov. 29 letter inquiring into FDA's delay in removing from the market generic conjugated estrogen products, which FDA considers bio-inequivalent to Wyeth- Ayerst's Premarin, and in establishing new standards for generic copies ("The Pink Sheet" Dec. 24, T&G-10). Peck reported that the agency is "considering regulatory actions" against both Zenith and Duramed due to "repeated quality- related problems." He noted that the two firms have recalled over 100 lots of the product since 1986. Two boxes of data from Wyeth-Ayerst, Duramed and Zenith data were delivered to Burlington and Bilstad's office area from the Regulatory Affairs Division in mid-August "when Dr. Burlington was on vacation," Peck's letter explains. A memorandum prepared by Regulatory Affairs to explain the contents of the boxes apparently was not received with the boxes, and when Burlington returned, he saw the boxes but "did not see a cover memorandum and hence did not identify their importance," Peck said. "Under the impression that they were extra copies of work assigned elsewhere, he proceeded to try to catch up on other priority generic drug issues that had arrived while he was on vacation." The boxes "were set aside until [generic drugs office State and Professional Liaison Donald] Hare began to track them on or about Oct. 29," the letter continues. When Hare found them, he "immediately referred" the boxes to Endocrine and Metabolic Drugs Division Director Solomon Sobel, MD, and to Bioequivalence Division Director Shrikant Dighe, PhD, for review. "These reviews have now been completed, and we are evaluating the merits of granting or denying a hearing" on FDA's proposal to withdraw the generic products, Peck said. "To the best of my knowledge and that of [CDER Deputy Director] Meyer, none of the events associated with the review of these data were in any way a reflection of a lack of commitment on our part in terms of my commitment to your subcommittee, nor should they be viewed as some kind of action against Barr Laboratories." The delay will be reviewed by FDA's recently established Special Review Panel on Alleged Retaliation ("The Pink Sheet" Oct. 1, T&G-1). "To assure that these events are evaluated by an objective party, [Deputy Commissioner James] Benson and I have agreed to refer this incident to outside consultants," Peck said. Panel members include APhA's Arthur Kibbe, PhD, independent consultant John Zerumbo, PhD, and Inspector General's Office investigator James Kopf. The letter also mentions another delay within FDA's Regulatory Affairs Division. The delay occurred earlier last summer, June 22- Aug. 9, "from when we received the data supporting a hearing request in our Regulatory Affairs Division to the time when the data were assigned to the appropriate scientific personnel for review," Peck said. Regulatory Affairs, which "carefully reviews and summarizes the major contested issues" involved in recalls, reviewed "eight volumes of material submitted by Duramed, Zenith and Wyeth- Ayerst," he explained. The division's workload is exacerbated by "competing priorities" for staff time, Peck said. Gerald Meyer "has since begun meeting with the division . . . to assess the resource problem and to develop a scheme for assigning center- level priorities" to the workload.
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