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Executive Summary

FDA "INTEGRITY" REPORT ON APPROVAL PROCESS DUE BY JAN. 9 to FDA Commissioner Kessler from the D.C. law firm of Shaw, Pittman, Potts & Trowbridge. The firm was hired by FDA as the second set of "integrity counselors" in Commissioner Kessler's program to make integrity a "bedrock" of the agency's operations. Another firm, Kutak, Rock & Campbell, was hired in late April to look at safeguarding confidential information ("The Pink Sheet" May 27, T&G-2). The contract with Shaw, Pittman for $ 710,558 was signed on July 10 ("The Pink Sheet" July 15, In Brief). Under the contract with FDA, Shaw, Pittman has been asked to report to FDA on two broad areas: the "accuracy and completeness" of data supplied to FDA by all industries regulated by the agency and the "quality of the systems or controls needed to determine how and when such data should be audited"; and the "integrity, objectivity and soundness" of FDA's internal decisionmaking processes for approvals and other regulatory decisions. Leading the investigations is attorney John Rhinelander. Under his direction will be three "teams" of investigators who will look at the accuracy and completeness of data as well as the soundness of FDA decisionmaking in the areas of drugs and biologics; food, cosmetics and veterinary medicine; and devices and radiologic health. Rhinelander, 58, had a long history of government service prior to joining Shaw, Pittman in 1977, including a stint as chief counsel at the Department of Health, Education and Welfare from 1973-75. However, he had no involvement in FDA's approval processes at that time. In addition, Rhinelander has served as chief council at the Commerce Department's Office of Foreign Direct Investments (1968-69) and was a legal advisor to the State Department (1969-71) and for the SALT arms reduction talks (1971- 72). Rhinelander served as undersecretary at the Department of Housing and Urban Development just prior to joining Shaw, Pittman. Thomas Lenhart, 44, will head the drugs and biologics team. The food, cosmetics and veterinary products team will be led by Dean Aulick, 41. Deborah Brand Baum, 31, will be the team leader for devices and radiological health. Baum appears to be the only one of the four with any direct pharmaceutical experience. She authored a paper for the Food, Drug & Cosmetic Law Journal (October 1984) on "The Utility in a Pharmaceutical Patent." In a July 19 "Talk Paper," Kessler explained that the approval system "has not always worked as well as it should, and so we are bringing in an outside firm to recommend how we can improve in these areas." FDA noted that "increasing stresses on FDA's resources have forced it to rely more heavily on regulated entities to ensure that the data they submit are complete and accurate -- in effect, asking companies to police themselves. In addition, the soundness of the agency's decisionmaking processes have been called into question." The integrity teams from Shaw, Pittman, Potts & Trowbridge have not met yet with Commissioner Kessler and his staff but expect to do so. Kessler put out a memo on June 6 to all staff discussing the appointment of the first integrity counselors, Kutak, Rock & Campbell, and calling on all staffers to tighten up information safeguards ("The Pink Sheet" June 17, T&G-11), but is not expected to put out a memo on the Shaw, Pittman appointment.

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