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FDA Pediatric Drug Division Director Will Be GSK’s Shirley Murphy

Executive Summary

Former GlaxoSmithKline NeuroHealth Specialty Division VP Shirley Murphy, MD, will become the first director of FDA's Division of Pediatric Drug Development effective Sept. 9

Former GlaxoSmithKline NeuroHealth Specialty Division VP Shirley Murphy, MD, will become the first director of FDA's Division of Pediatric Drug Development effective Sept. 9.

Murphy left GSK in January to return to clinical practice. She joined the company in 1998. Dianne Tult, previously VP-business development, has replaced her.

Prior to joining GSK, Murphy spent 20 years at the University of New Mexico, where she headed the Division of Pulmonary Medicine and chaired the Department of Pediatrics. At the end of that period, former FDA Commissioner Jane Henney, MD, served as VP-health systems for the university.

While at New Mexico, Murphy served as chair of FDA's Pulmonary-Allergy Drugs Advisory Committee.

The pediatric division is part of the Office of Counterterrorism & Pediatric Drug Development, directed by Dianne Murphy, MD (1 (Also see "FDA Pediatric/Counterterrorism Office Will Announce Division Directors In Fall" - Pink Sheet, 1 Jul, 2002.), p. 18). The pediatric responsibilities are currently being handled by Team Leader Debbie Birenbaum, MD.

Shirley Murphy received her medical degree from the University of Kansas School of Medicine and performed her residency training at UCLA-Harbor General Hospital. She is board certified in pediatrics, pediatric pulmonology and allergy/immunology.

Murphy chaired the National Heart, Lung & Blood Institute's Asthma Expert Panel in 1997 that produced guidelines for the diagnosis and management of asthma (2 (Also see "GLAXO WELLCOME SEREVENT WITH CORTICOSTEROIDS MAY SUBSTITUTE FOR A DOUBLE DOSE OF CORTICOSTEROIDS -- NHLBI GUIDELINES; CONTROL OF NOCTURNAL SYMPTOMS CITED" - Pink Sheet, 3 Mar, 1997.), p. 11).

Murphy's experience in asthma and pediatrics could be useful as the agency implements the chlorofluorocarbon phase-out rule, which mandates the phase-out of CFC-containing products beginning next year. The rule allows an exemption if a product is found to be "essential" for a particular population ("3 (Also see "CFC-Containing Albuterol Phase-Out Review To Begin January 2003" - Pink Sheet, 29 Jul, 2002.), p. 27).

Murphy chaired an advisory committee meeting in 1997 which concluded that CFC-free dry powder inhalers would not be an acceptable alternative product for children. The committee recommended development of hand-held nebulizers (4 (Also see "DPIs CONSIDERED MEDICALLY ACCEPTABLE ALTERNATIVE TO CFC PRODUCTS, FDA ADVISORY CMTE. SAYS; POTENCIES OF CFC-FREE AND CFC PRODUCTS SHOULD BE COMPARED" - Pink Sheet, 21 Apr, 1997.), p. 8).

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