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 Center for Drug Evaluation & Research is up to 267 reviewers as the agency continues to edge upward in its attempt to build a larger drug review staff. The current review staff level represents a net gain of six positions over a year ago and 28 positions more than at the beginning of 1988. The fastest growing review areas are the two groups established in 1989 and 1988: the Pilot Drug Evaluation Staff (under John Harter) and the Division of Anti-Viral Drugs (under Ellen Cooper). Harter's group, which includes anti-inflammatories and analgesics in its purview, has grown to a total of 35 staffers in the past year. The Anti-Viral Drugs Division has added seven reviewers during the last year and now has 30. * The changes in staff size indicate that FDA is redeploying some of its reviewing resources to hot areas of drug development and applications review. The agency appears to be keeping its head above water in terms of matching resources to new projects but it is not making much progress at enlarging overall resources. Some of the other traditional areas of drug development activity are treading water in terms of FDA review resources. The Metabolism & Endocrine Drugs Division, for example, increased by a total of three reviewers; the division added four medical officers, but lost a pharmacologist. The Cardio-Renal and Gastrointestinal & Coagulation units each gained a total of one reviewer. In its efforts to increase the number of drug reviewers, FDA has been hampered by the lack of available office space at its Rockville headquarters (the Parklawn Building). During 1988, when the Anti-Viral Divisions was established and 22 new reviewers joined the agency, the Center for Drug Evaluation & Research basically reached full capacity due to the office space problem. Harter's Pilot Drug Evaluation Staff was set up in April 1989, drawing from three existing review areas. The new division took over the drug abuse unit and review of analgesics from the Division of Neuropharmacological Drugs. The pilot drug division also assumed review of anti-inflammatory drugs from the Division of Oncology & Radiopharmaceutical Drugs and evaluation of anesthetic agents from the Division of Surgical-Dental Drugs. The purpose of the new division is to provide an experimental ground for creating innovations in new drug review. It is Harter's division that has been experimenting with the concept of the NDA Day to bring together FDA reviewers, advisory committee members and representatives of the sponsor in a concentrated effort to resolve the final questions about a pending application. When the Pilot Drug Evaluation Staff was first established, FDA estimated that the unit would have a staff of 26 employees, including 12 medical officers and five consumer safety officers ("The Pink Sheet" May 1, p. 3). According to staffers, the division currently has a total of 35 employees: 19 reviewers, seven consumer safety officers, and nine other staff members. The reviewers consist of: 10 medical officers, four pharmacologists, and four chemists (see chart, p. 7, for breakdown of current reviewer levels by division). In conjunction with the establishment of the Pilot Drug Evaluation staff, the radiopharmaceutical drug review group joined with the Division of Surgical-Dental Drug Products. The pulmonary drug review section also moved from the Surgical-Dental Division to the Oncology Division. According to recent figures, the Anti-Viral Division has 30 reviewing personnel: 13 medical officers, seven pharmacologists, six microbiologists, and four chemists. The division has an entire staff of 48 employees, including six consumer safety officers. Over the course of a year, the Anti-Viral Division would like to recruit nine more reviewers, a division official said. The structure of the Anti-Viral Division is changing. This summer, the division's deputy director Robert Osterberg, PhD, transferred to the Division of Anti-Infective Drugs as a supervisory pharmacologist. In lieu of directly replacing Osterberg, the group is creating three assistant deputy positions: an assistant director-medical affairs, assistant director-preclinical affairs, and a general deputy director. Wendy Strongin, MD, is serving in an acting capacity as the general deputy director.

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