Executive Summary

GENERIC DRUG REVIEWERS MUST COMPLY WITH NDA PROCEDURES for completing and documenting review of drug marketing applications, FDA said in a Nov. 8 policy guide. The guide instructs FDA generic drug staff to follow Center for Drug Evaluation Guide 4800.2, which "describes the respective role of reviewers, supervisors and deciding officials in the drug review process and explains how institutional decisions are reached on drug application matters." Under the policy guide, the "responsibility for the content of a review rests with the reviewer," and the signature of the review branch supervisor is required as a "personal endorsement" of the conclusions in the review. The document specifies that "reviews should contain enough detail so that a trained person reading them will understand the basis for any recommendations and processes by which they were made." If a supervisor does not concur with the reviewer's conclusions, a memo documenting the disagreement is to be included in the administrative file for the ANDA or AADA application. Surveillance of applications under review is also augmented by the policy guide. Once a review is final, "it may not be altered or removed from the administrative file by anyone, including the reviewer," the guide states, adding that "document room staff should be alert for items proposed for inclusion in the file that are unconventional and do not have official endorsement." A Nov. 7 memorandum to staff from Center for Drug Evaluation Review Director Carl Peck, MD, also addresses one of the questions raised at a July Capitol Hill hearing -- access to FDA field inspection reports by division reviewers. The Peck memo formalizes the procedure by which a reviewer may submit an Establishment Evaluation Request to the Office of Compliance to obtain a status assessment of a facility. To receive a more detailed field report, reviewers must make written requests through their supervisors, explaining the reason for their request. "I personally endorse free flow of information between the FDA field, the CDER Office of Compliance and drug application reviewers," Peck commented. FDA released two additional policy guides this month. The guides supplement the agency's "Division of Generic Drugs Policy and Procedure Guide," which has been coming out in installments since July. One of the guides eliminates FDA's previous requirement for separate ANDAs for multiple manufacturing sites. "Upon reflection, Division management believes that imposing a single site limitation in an ANDA or AADA does not serve a necessary purpose, is unduly restrictive and can be relaxed," the guide states. However, each additional site must be described in a separate section in the application. FDA agreed to the need for such a policy change in a July meeting with representatives of the Generic Pharmaceutical Industry Association. The second policy guide relaxes the requirement for testing at a U.S. laboratory of finished dosage forms manufactured outside the U.S. It had been the division's policy to require U.S. testing of finished dosage forms of approved generic drugs manufactured in any foreign facility. The guide states that this requirement has been dropped for generic drugs manufactured in facilities located in a country that has a bilateral CGMP inspection agreement with the U.S., or "in a country that is not covered by an FDA inspection agreement" but has acceptable CGMP status based on the last FDA inspection of the facility.