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OTC OFFICE DRUG REVIEW STAFF PROJECTED TO GAIN FIVE EMPLOYEES

This article was originally published in The Tan Sheet

Executive Summary

OTC OFFICE DRUG REVIEW STAFF PROJECTED TO GAIN FIVE EMPLOYEES in fiscal year 1994 from funds derived from user fees under a staff allocation plan devised by Center for Drug Evaluation and Research management. The allocation of five additional employees would go to the Office of OTC Drug Evaluation's Medical Review Staff, which was formed earlier this year with the appointment of Debra Bowen, MD, as director in order to provide the OTC office with NDA review capabilities. CDER administrators are projecting an expanded OTC review staff in anticipation of the office assuming a greater role in new drug reviews, particularly for Rx-to-OTC switch applications. Under the FDA user fee act passed by Congress in 1992, the agency is directed to use the revenues from drug and biologics user fees for improving review functions and expanding the review staff within the centers. Based on internal planning allocations, the Center for Drug Evaluation and Research is set to gain a total of 121 full-time equivalents during the current fiscal year from user fees. The allocation sets a hiring ceiling for CDER of 161 employees in FY 1994. Speaking at the Nonprescription Drug Manufacturers Association's annual research and scientific conference on Nov. 19, FDA Monograph Review Staff Director William Gilbertson, PharmD, pointed out that "there has been no growth of the [OTC] office in the last year in terms of new additions other than the appointment of [Bowen]." Gilbertson reported that the OTC office currently has a total of 30 professional staff and nine clerical workers and that 21 of the professional staff are devoted to the OTC monograph review. The medical staff will soon double in size with the addition of another medical officer joining Bowen sometime in December, Gilbertson indicated. The appointment is not yet official.
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