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's Anti-Viral Drug Products Division plans to take on an additional 11 medical reviewers by October 1989 in anticipation of an increase in NDA and IND applications. The majority of new reviewers will be medical officers, he added. The planned expansion of the Anti-Viral division review staff represents a near 50% gain over current staff levels. As of Jan. 23, the Anti-Viral division was comprised of 23 reviewers and 13 general staff employees. In a form of organizational mitosis, the nucleus of the Anti-Viral division -- six of the 23 reviewers, including Anti-Viral Division Director Ellen Cooper, MD, -- were transferred from the Division of Anti-Infective Drugs when the Anti-Viral division was first established. Deputy director of the Anti-Viral division is Robert Osterberg, PhD. The Anti-Viral Division currently consists of nine medical officers, five microbiologists, five pharmacologists and four chemists (see chart on following page for breakdown of current reviewer levels by division). The division was set up last March to handle the large number of NDAs and INDs for AIDS drugs that were being submitted to the Division of Anti-Infective Drugs. Further expansion of the Anti-Viral Division is dependent on how active the pharmaceutical industry and researchers are in submitting new drug applications. Although the limited office space in FDA's Parklawn Building has been a long existent road block to staff expansion for most drug review divisions, it has not deterred plans for staff growth, at least in the near future, for the Anti-Viral Division. According to Osterberg, the Anti-Viral Division is slated to expand into office space that will become available once the Center for Biologics Evaluation and Research's (CBER) Division of Biological INDs moves into the Park Building directly across Fishers Lane from the Parklawn Building in Rockville, Md. CBER and the Center for Drug Evaluation and Research (CDER) have been reviewing unused space in the Park Building to determine if it would meet office space requirements ("The Pink Sheet" Jan. 30, T&G-15). Increased utilization of the Park Building is part of an overall initiative by the agency to deal with its growing need for more facilities. FDA's long-term goal is to have a campus similar to that of the National Institutes of Health that would allow for consolidation of agency activities and the construction of new lab facilities that could aid FDA in recruiting scientific staff. The campus idea has been a dream of agency commissioners going back to the 1970's. In December, top FDA officials met with representatives of Maryland's Montgomery County government to discuss the agency's facility needs and its immediate, mid-range, and long-term goals. Additional office space is crucial to FDA's staffing plans. Although there was growth in some of CDER's reviewing divisions during 1988, the Center essentially reached full capacity during the summer due to the lack of available space for new hires, CDER's Office of Management said. In total, there were 261 reviewers for all of CDER's reviewing divisions at the beginning of 1989, compared to 239 at the beginning of 1988 ("The Pink Sheet" March 14, 1988, p. 9). The overall gain of 22 new reviewers during 1988 can mostly be attributed to the addition of the Anti-Viral Division. Outside of the newly formed Anti-Viral Division, review staff in the other seven divisions declined by a total of one reviewer. However, FDA has made significant strides in reorganizing and expanding the CDER review staff in the past two years. Since January 1987, the CDER review staff has added 56 new reviewers -- an increase of 26%. In addition, the agency has created two new reviewing divisions in that time. Besides the creation of the Anti-Viral Division to deal with an anticipated influx in AIDS applications, the agency formed the Gastrointestinal and Coagulation Drug Products Division in 1987 partly to improve management focus over the wide range of products covered by the Cardio-Renal Drug Products Division. FDA also has since added a new office to improve the agency's recruitment of new medical review staffers, called the Office of Professional Development and headed by William Abrams, MD, who is on leave from Merck. CDER also brought over a professional personnel staffer from the National Institutes of Health, Richard Southers, to focus on physician recruitment. A new plan to improve FDA's recruitment process for medical reviewers, written by Southers, was completed last summer and is now being implemented. The agency has also worked with the American Medical Association and the Institute of Medicine on plans to bring on part-time medical officers to help with the review load. As of January 1989, CDER's overall review staff included 13 part-time reviewers, including 12 medical officers. The two divisions to show any real expansion in review staffs during the past year were the Division of Gastrointestinal & Coagulation Drugs and the Division of Oncology & Radiopharmaceutical Drug Products. Each added four new reviewers. The Oncology & Radiopharmaceutical division gained three medical officer positions and a pharmacologist during 1988. The Gastrointestinal division added two new medical officer positions and two pharmacologists. Chart omitted.

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

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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