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

NDA SUPPLEMENT BACKLOG MAY BE INCREASED BY ANDA CATCH-UP plan, which calls for using new drug chemists to help eliminate the ANDA backlog in FDA's generics division, FDA Center for Drug Evaluation and Research Director Carl Peck, MD told CDER staff in a Sept. 25 memo outlining the agency plan. Peck noted that the agency expects the plan to be implemented "without any significant disruption in the review of NDAs" over the short term. However, Peck added, "it is anticipated that there may be some increase in the backlog of unreviewed chemistry and manufacturing control supplements" in the new drug reviewing divisions. Peck assured staff that agency management "will make every effort to minimize this impact, and...will monitor all pending work closely." The supervisory review chemists, Peck said, will have the responsibility for managing and assigning ANDAs "in such a manner as to minimize the impact on new drug evaluation and avoid delaying any pending NDA otherwise approvable." The ANDA backlog plan emerged from a challenge by Peck to CDER chemists, issued at a recent chemistry staff retreat, to devise a program to reduce the number of overdue ANDAs ("The Pink Sheet" Sept. 24, p. 2). Incoming Office of Generic Drugs Director Roger Williams also participated in the meeting. The Division of Generic Drugs began farming out applications on Oct. 5, one day before the division was scheduled to move out of the Parklawn building. FDA plans to distribute ANDA applications to supervisory chemists in the new drug divisions based on the number of primary review chemists and microbiologists in each division. However, some microbiologists in the Anti-Infective, Medical Imaging, and Antiviral divisions will not be expected to review ANDAs. An FDA chart designates the number of chemists in each division and the number of ANDAs expected to be assigned to each division: the Pilot Drug Evaluation Staff with three chemists will review 14 ANDAs; Cardio-Rental's eight chemists will review 31 ANDAs; Neuropharmacological Drug Products's seven chemists will review 26 ANDAs; Oncology and Pulmonary's 12 chemists will get 38 ANDAs; Medical Imaging, Surgical and Dental, with eight chemists, will get 16 ANDAs; Gastrointestinal's three chemists will look at eight ANDAs; Metabolism and Endocrine's seven chemists will get 15 ANDAs; Anti-Infective, with seven chemists and four microbiologists, will review 53 ANDAs; and Antiviral's five chemists will be responsible for eight ANDAs. Applications will be distributed "to the extent possible" according to the generic division's "first in-first reviewed" policy, the memo notes, with the primary focus on unreviewed original ANDAs. In addition, Peck continued, "every attempt also will be made to assign applications to the division with primary responsibility for the innovator drug product; however, it is recognized that this may not always be possible." Noting that ANDA reviews will be assigned "high priority," Peck said that typewritten reviews of the applications must be completed within three weeks. For the chemists to accomplish this task, Peck said "the center will authorize overtime for any chemist wishing to participate in primary review activities on an overtime basis." FDA has said previously that it would be requesting that chemists contribute up to 20 hours overtime per pay period to the effort. The plan may face a large and unexpected obstacle if the budget impasse in Congress results in wide-scale furloughs at the agency from Gramm-Rudman sequestration. While the program will run for an "indefinite period," CDER said it plans to re-evaluate the program at the end of two months. "It will be scaled back and eventually eliminated as we are able to recruit additional staff for generic drugs and reduce the backlog to something manageable by the generic staff," Peck remarked. He noted that the Division of Generic Drugs "has an exception to the hiring freeze and will be vigorously recruiting chemists." Although the new drug evaluation will be given copies of completed reviews, the memo states that "the supervisor is not responsible for supervisory input into the actual work product." The supervisory and consistency reviews will be conducted by the Division of Generic Drugs. New drug chemists will receive "standard chemistry review format and sample reviews, to illustrate the length and extent of comment that is ordinarily expected in generic drug reviews," the memo notes, adding that the "extent of comments under several review items may be less in the generic drug reviews than is customary in new drug evaluation reviews."

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