Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

FDA CBER DIRECTOR PARKMAN RETIRING FROM AGENCY JULY 14 after 18 years of service with the agency and 30 years with the federal government. Parkman, who will turn 58 later this month, has headed FDA's Center for Biologics Evaluation and Research since November 1987 when it was split off from the old Center for Drugs and Biologics. Parkman has also spearheaded the agency's efforts against AIDS, serving as the director and coordinator of FDA's AIDS program since its creation two-and-a-half years ago. FDA described Parkman's May 4 announcement as a "surprise" to the agency. In an FDA "Talk Paper" on his retirement, the agency said Acting Commissioner Benson accepted Parkman's resignation "with regret" and "paid homage to [his] role 'as one of the principal liaisons with the scientific community,' and his 'significant personal leadership in the fight against AIDS." Prior to his position as CBER director, Parkman served as deputy director of FDA's Bureau of Biologics from 1973 to 1982, as scientific director of FDA's National Center for Drugs and Biologics from 1982-1984, and as deputy director of the Center for Drugs and Biologics from 1984 to 1986. He also served as acting director of the combined drugs/biologics center for a year (from late 1986-1987) and was among the lead candidates to head the center before FDA decided to split it into drugs and biologics. Parkman began his Public Health Service career at Walter Reed Army Medical Center, serving as a virologist from 1960 to 1963, and then moved on to the National Institutes of Health where he worked first as a medical officer in the Division of Biologic Standards (1963-1966) and then as a section chief in the Laboratory of Viral Immunology (1966-1972). He is well known for his work in isolating the rubella virus and developing the first successful rubella vaccine. He holds two patents for the vaccine that are assigned to the government. Parkman's retirement will create another vacancy in FDA upper management. In addition to the continuing search for FDA Commissioner, Office of Epidemiology and Biostatistics Director Gerald Faich recently announced that he will be leaving the agency (see T&G below). The agency said its plans for finding a replacement for Parkman are not yet decided. Current top management in CBER includes Deputy Director Gerald Quinnan, MD, and Associate Director for Research and Regulatory Coordination Elaine Esber, MD. Esber headed the old Office of Biologics before the Center split in 1987.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts