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Executive Summary

Ex-BuDRUGS DIRECTOR RICHARD CROUT JOINING BOEHRINGER MANNHEIM as VP-medical director with the responsibility to build a medical research and development office for the German firm in the U.S. Crout, 51, has been heading the NIH office in charge of the consensus development conferences since the early summer of 1982. Prior to going to NIH, Crout was director of FDA's old Bureau of Drugs for nine years. The Boehringer Mannheim position will be Crout's first job with a health products mfr. -- and possibly his chance to see the drug approval procedures from the other side. He taught for eight years before coming to Washington. While at NIH Crout increased the number of consensus conferences related to pharmaceutical issues. A number of the pharmaceutical-related meetings he organized dealt with key issues with which he had been involved at FDA. For example, recent consensus conference topics have included hypertriglyceridemia, sleep disorders and analgesic-associated kidney disease. His final conference, scheduled for April 2-4, is on osteoporosis. Boehringer's presence in the U.S. has been limited to the medical device field. Beginning in 1975, the German firm began an acquisition drive into the U.S. medical market with the $23 mil. cash purchase of BioDynamics, a diagnostic products mfr. and orthopedic products firm through its DePuy subsidiary. During the last week of 1978, Boehringer quickly stepped into a crisis at Hycel and purchased that firm for $39 mil. in cash. Hycel, a mfr. of clinical chemistry analyzers and reagents, has since been folded in with the BioDynamics diagnostics to form Boehringer Mannheim Diagnostics, headquartered in Indianapolis. In Europe the firm's major drug products are in the cardiovascular and antidiabetic areas. The German firm will be building a drug research and development capability in the U.S. from scratch. Crout is charged with putting together that dept. It will be headquartered in the D.C. area. In a resignation letter to NIH Director James Wyngaarden, Crout described his new position as "an opportunity to build from scratch a medical R&D group in the Washington area to help bring to American medicines a number of promising new agents and ultimately to establish a new drug firm in the U.S." Crout's resignation from NIH becomes effective April 16. Boehringer has occasionally had products approved by FDA in the past. For example, in 1982, the firm received one ANDA for chloramphenicol sodium succinate. Boehringer also has a cardiovascular product, isosorbide-5-mononitrate, undergoing FDA review through a licensing agreement with Robins.

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