EW# 13,638 EMPLOYMENT EXPERIENCE:
2003 - Independent consultant, trainer and expert witness in all aspects of drug regulation and in establishing and maintaining effective working relations with the FDA. ● CConsults for pharmaceutical firms on building and maintaining good regulatory relations with the FDA and in developing strategies for achieving regulatory goals. ● Serves as expert witness in litigation involving drug regulatory issues and FDA policies and practices. Prepares reports and testifies in wide variety of cases, on FDA’s processes and procedures, compliance with FDA’s regulations and guidelines on labeling, advertising, new drug, generic drug and other issues. 1995 – 2003 Ombudsman and Senior Advisor Center for Drug Evaluation and Research Food and Drug Administration SES/Level 2 · Advised Center Director on issues and potential solutions concerning relations with the industry, public and health care professionals; emerging problems within the Center, including the need for new or changes to existing procedures and on intercenter jurisdiction. · Handled complaints, appeals, and counseled regulated industry and other external parties on full array of CDER processes and policies, and counseled CDER employees on job related problems. · Proactively promoted improved communication between the industry, health professions, public and CDER through informal meetings with industry, training of reviewers, publications and speeches. · Developed CDER position and spoke for Center Director on issues involving intercenter jurisdiction and combination products. · Represented CDER on the FDA Leadership Development Committee and other high level agency groups. 1994 ‑1995 Deputy Director for Program Management Office of Drug Evaluation I Center for Drug Evaluation and Research SES/Level 2 · Managed program activities and operations of the largest office in the Center for Drug Evaluation and Research responsible for reviewing new drug applications prior to marketing. · Helped successfully implement Prescription Drug User Fee Act goals. · Advised Office Director on emerging management problems and recommended solutions. · Served as executive secretary for the Medical Policy Coordinating Committee. 1990 ‑1994 Acting Director Office of Drug Standards Center for Drug Evaluation and Research SES/Level 2 · Directed the activities of divisions responsible for regulation of prescription drug advertising and promotion practices, and the safety and effectiveness of nonprescription drugs. · Performed all management functions, including strategic planning, resource allocation, budget control, and all personnel actions. · Planned and implemented a reorganization of the division that regulates drug advertising, greatly expanding its capabilities and resources. 1983 ‑1990 Deputy Director Office of Drug Standards Center for Drug Evaluation and Research SES/Level 2 · Directed the activities of five divisions responsible for regulation of prescription drug advertising and promotion practices, determining the safety and effectiveness of nonprescription and generic prescription drugs, determining pharmacokinetic characteristics and bioequivalence of drugs. · Performed management functions, including strategic planning, resource allocation, budget control, and all personnel actions. · Worked with Department of Health and Human Services and Congressional staffs on the enactment and implementation of major legislation, testified at Congressional hearings, and prepared testimony. · Served as spokesman for programs, made speeches, wrote and edited agency press releases, published journal articles and edited articles for publication, and served as ombudsman, receiving and handling complaints from regulated industry. · Instrumental in the introduction of computers to all divisions in the office and in their use to improve effectiveness of operations. Served on the IT Policy Committee for the Center for Drug Evaluation and Research. · Member of or chaired Center and Agency groups, including the FDA Management Development Committee, the Therapeutic Inequivalence Action Coordinating Committee, the Bioequivalence Hearing and Task Force, and the Drug Efficacy Study Implementation Committee. · Agency expert on drug industry pricing and marketing practices, serving on staff to HHS Pharmaceutical Reimbursement Board, providing expert input on the quality of drugs and their regulatory status for the Maximum Allowable Cost Program. Participated in recommendations for establishing reimbursement rates for prescription drugs. 1982 ‑1983 Director, Regulatory Affairs Bureau of Drugs Food and Drug Administration GM‑15 · Directed the staff responsible for writing all drug rules and regulations. Also actively participated in or led Bureau actions in the area of regulatory affairs. Such activities included developing requirements for medical foods and responding to the Tylenol tampering poisonings by publishing standards for tamper resistant packaging. 1976 ‑1982 Special Assistant to the Director Bureau of Drugs GM‑14 · Staff assistant to the Bureau Director and Deputy Director, specializing in regulatory issues. · Coordinated Agency and Bureau regulatory activities, included chairing task forces on the market withdrawal of products and participating in the Commissioner's task forces on the new drug approval process and on vitamins and minerals. · Served detail as Acting Director, Division of Generic Drugs in 1980 (five months) to replace director who was transferred pending investigation of conflicts of interest. Continued for an additional three months as Acting Deputy Director of the division to complete plans for new computerized ANDA tracking system. 1974 ‑1976 Chief, OTC Compliance Branch Division of Drug Labeling Compliance Bureau of Drugs GS‑14 |
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