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Executive Summary

FDA lawyer Edward Basile will become the senior liaison attorney for the Natl. Center for Drugs & Biologics following the departure of Michael Peskoe, who is leaving the agency Nov. 9 to join the New York law firm of Bass & Ullman. Basile has been with the agency nine years. He has served as Associate Chief Counsel for Biologics since 1980, Associate Chief Counsel for Enforcement since 1975, and was also Associate Chief Counsel for Radiological Health (1977-80). He will now be the senior attorney handling cases for both drugs and biologics. Peskoe is the fifth FDA lawyer to leave the General Counsel's Office since January, and together the group represented almost 50 years of experience at the agency.Since three of the five were senior drug lawyers, the agency's legal staff could be a little shorthanded in the drug area as FDA begins to implement the Waxman/Hatch bill. Peskoe has been with the agency for 10 years. Outside of his regular legal workload, he also served during his tenure on the Congressional Commission on the New Drug Approval Process (McMahon Commission), the Commissioner's Task Force on the New Drug Approval Process, and the agency's Cmte. on Patient Education. Peskoe is joining a firm with extensive experience in representing generic drug interests. Senior partner Milton Bass is the lawyer for the Natl. Assn. of Pharmaceutical Mfrs., which took the position during the patent restoration/ANDA debate that new legislation was not required to allow FDA to approve post-1962 ANDAs. The addition of Peskoe indicates that while the firm may continue to disagree philosophically with the Waxman/Hatch bill, it is preparing to handle realities of the recently enacted legislation. Two New Attorneys At FDA, Sandra Barnes And Alexis Prease, Will Initially Handle Litigation Until his departure from the agency on Oct. 9, Forrest Paterson was the FDA lawyer with the most tenure, 15 years. Patterson, now with Carter-Wallace, was Associate Chief Counsel for Drugs from 1979 to 1984, Deputy Chief Counsel for Administration (1976-1979), and a staff lawyer from his start with the agency in 1969 until 1976. Prior to joining FDA, Patterson spent two years with the American Pharmaceutical Assn. Jacqueline Eagle, who served as Associate Chief Counsel for Drugs (1982-present) and Assistant Chief Counsel for Drugs (1978-82), joined the Justice Dept. in February. Assistant Chief Counsel for Enforcement Irene Solet is also leaving FDA for the Justice Dept. Assistant Chief Counsel for Enforcement Jeffrey Gibbs joined the D.C. firm Hogan & Hartson in the beginning of the year. In addition, Jess Stribling, who moved from Deputy Chief Counsel for Administration to become executive assistant to the commissioner in August 1983, is joining the law firm Burditt, Bowles & Radzius ("The Pink Sheet" Sept. 24, "In Brief"). The agency is left with two attorneys to principally handle drug cases. In addition to Basile, Associate Chief Counsel for Drugs Kathleen Blackburn, who has been with the agency since 1976, will deal with drug issues. Specific assignments are not yet fixed. Other attorneys will probably be assigned to assist in future drug cases. Two new attorneys joined the agency in September. They are Sandra Barnes, who graduated from the University of Maryland Law School in 1984, and Alexis Prease, a 1984 graduate of the University of North Carolina. They will initially handle litigation.

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