FDA Office of Vaccines Research & Review Director Karen Midthun, MD, has experience in early development studies of vaccine candidates for HIV, hepatitis A and rotavirus.

Midthun returned to the Center for Biologics Evaluation & Research vaccines office Sept. 10 from the Anti-Inflammatory, Analgesic & Ophthalmic Drug Products Division within the Center for Drug Evaluation & Research.

Midthun began her career at FDA in 1993 as a medical officer in the Vaccines & Related Products Applications Division.

She was named branch chief of CBER's Vaccines Clinical Trials division in 1997, before joining CDER as acting director of the Office of Drug Evaluation V. She was named director of the analgesics division in December (¹ Also see "FDA Makes Midthun Analgesic/Anti-Inflammatory Division Permanent Director" - Pink Sheet, 20 December, 1999.).

Before joining FDA, Midthun was on the faculty of Johns Hopkins University, specializing in infectious diseases. She worked on Phase I and II clinical trials of investigational vaccines during that period.

Former Office of Vaccines Research & Review Director Carolyn Hardegree retired from the agency in 1999. OVRR Deputy Director William Egan, PhD, served as acting office director after her departure. He will remain as deputy director under Midthun. Acting Deputy Director Norman Baylor, MD, will return to his position as associate director for policy at OVRR.

The vaccines office is facing several sensitive public health and political challenges.

Rep. Burton (R-Ind.) has been trying to establish a link between vaccines and side effects like autism. His investigation has turned to questioning the conflicts of interest of federal vaccine advisory committee members (² [A#00620350014]).

The agency has also been working with vaccine suppliers to ensure that there is no shortage of influenza vaccine for the upcoming flu season.

A more significant long-term problem for FDA may be ensuring that good manufacturing practices standards can be maintained without driving manufacturers out of the business (³ Also see "CDC Stresses Early Pneumococcal Vaccinations In New Flu Recommendations" - Pink Sheet, 9 October, 2000.).

Jonca Bull, MD, has replaced Midthun as acting director of the Division of Anti-Inflammatory, Analgesic and Ophthalmic Drug Products and remains deputy director of ODE V.

Formerly Acting Director of FDA's Office of Women's Health, Bull left at the end of July for the newly created position within ODE V. Bull previously worked in the Office of the Commissioner as a special assistant and medical advisor to the deputy commissioner for operations.

Following Bull's departure from the Office of Women's Health, the position of acting director was split between Science Projects Manager Margaret Miller, PhD, and Health Projects Manager Marcia Henderson.

At that time a search committee was formed to appoint a successor to Bull; the agency indicates that it has ended the last phases of recruitment and is close to appointing a new permanent director.

Another change within CBER is the appointment of Amy Rosenberg, MD, as the permanent director of the Division of Therapeutic Proteins in the Office of Therapeutics Research & Review.

Rosenberg was the division's deputy director when it was formed in October 1999 and has served as acting director since Giovanna Tosato departed in November to join the National Cancer Institute, where she is now head of the Molecular & Cell Biology Section.

Rosenberg joined FDA in 1988 in the Division of Cytokine Biology. She served as chief of the Laboratory of Immunology and then as deputy director in the Division of Hematologic Products before joining the new therapeutic proteins division.

In CDER, Marianne Mann, MD, has joined the Division of Pulmonary & Allergy Drug Products as deputy director. She previously served as deputy director of the Division of Reproductive & Urologic Drug Products. The agency has started a search for a new deputy director for the division.

The previous pulmonary division deputy, Martin Himmel, MD, was named deputy director of the Office of Postmarketing Drug Risk Assessment at the end of July.

FDA Vaccines Office Head Midthun Joins From Analgesic Division

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