Special Report: "Recent Evolution of the Drug Regulatory Process," FDA/FDLI Live Satellite Video Conference

Special Report: "Recent Evolution of the Drug Regulatory Process," FDA/FDLI Live Satellite Video Conference

by Julie H. Byerly, RAC, AccuReg Associate

On Thursday, November 9, 1995, the Food and Drug Law Institute and the Food and Drug Administration presented a live satellite video conference entitled "Recent Evolution of the Drug Regulatory Process." The conference was the first involving representatives from FDA's Center for Drug Evaluation and Research (CDER). The moderator for the conference was Mark Barnett, Assistant Director for Education and Communications at the Center for Devices and Radiological Health (CDRH) and panelists included Janet Woodcock, M.D., CDER Center Director, Murray Lumpkin, M.D., CDER Deputy Center Director for Review Management, and Roger Williams, M.D., CDER Deputy Center Director for Pharmaceutical Sciences.

A primary topic of discussion was the month-old reorganization of CDER. CDER is now divided into the following major offices: Office of Management, Office of Training and Communication, Office of Compliance, Office of Pharmaceutical Sciences and Office of Review Management. The primary product review and evaluation groups are the Office for Review Management, headed by Murray Lumpkin, MD, and the Office of Pharmaceutical Science, headed by Roger Williams, MD. The new structure is intended to improve the efficiency and consistency of product application review. The Office of Pharmaceutical Sciences will be responsible for all chemistry-related (CMC) issues, and the Office of Review Management will handle all of the remaining evaluations involved in application review. CDER representatives believe that consolidation of the chemistry review process will improve consistency in all product reviews. In the past, requirements could differ depending upon the experience of the various division representatives to which a particular product application was assigned. Now, with chemistry review consolidated into one office, scientific evaluations can be objectively made for product classes as a whole. The remainder of the application review will then be handled by the drug evaluation division within the Office of Review Management that can most appropriately address the clinical and other technical aspects of the product.

Another development of this CDER reorganization was the dissolution of the Office of OTC Products. OTC products are not user fee funded; therefore, that division was downsized. All OTC activities are now handled by the Division of OTC Evaluation within the Office of Review Management. CDER representatives pointed out, however, that despite the downsizing of the Office of OTC Products, much of the OTC-related activity is not monograph-oriented, but rather involves prescription to OTC switches, which are user fee funded. Initiatives are underway to better define the policies for conversions from prescription to OTC classification.

Another modification resulting from the reorganization of CDER is the establishment of a CDER-level ombudsman - Jim Morrison. Despite the existence of an agency-level Ombudsman's Office, headed by Amanda Pedersen, CDER officials believed there was a need for oversight in settling disputes within the CDER. Dr. Woodcock pointed out that "people have a right to disagree with us, " and "we are open to discussion." She encouraged applicants to deal with their reviewing supervisors first, but in the event that those discussions are not fruitful, to seek assistance from the CDER Ombudsman.

The panelists dealt with the Prescription Drug User Fee Act to some extent. They pointed out that part of the motivation for the CDER reorganization was to more effectively meet user fee goals. The user fee program specifies that priority NDAs should be acted on within 6 months, and standard NDAs should be acted on within 12 months. Similar time requirements are imposed on reviewing supplements and resubmissions. The user fee goals required that those timeframes are met 55% of the time in fiscal year (FY) 1994, 70% of the time in FY 1995, 80% of the time in FY 1996, and 90% of the time in FY 1997. FDA succeeded in meeting those goals in FY 1994 and, although the data are not in, they believe that FY 1995 will be as successful.

The panelists also spoke about FDA's strong involvement in the Global Harmonization Movement. FDA will participate in the ICH 3 Meeting at the end of November in Yokohama, Japan to discuss harmonization initiatives. They pointed out their desire to move toward not only harmonization of regulatory requirements but also to a collaboration of review. This may or may not be accomplished through ICH, but they believe it is the direction in which they should be going.

Overall, Janet Woodcock and her CDER staff seem very eager to "partner with industry." Only by working together can novel, safe and effective products be brought to market for the public benefit.

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