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

ANDA APPROVAL SIGN-OFF AUTHORITY PASSED FROM CDER DIRECTOR PECK to the new acting director of FDA's Office of Generic Drugs, Bruce Burlington, MD, and Acting Deputy Director Nicholas Fleischer in a Nov. 3 memo from Peck. The internal FDA announcement comes exactly one month after the acting appointments of Burlington and Fleischer to head the newly-created Office of Generic Drugs. Last May, Center for Drug Evaluation and Research Director Carl Peck and CDER Deputy Director Gerald Meyer took on the added responsibility for signing off on ANDA approvals. The decision was made as part of a general realignment of generic drug division responsibilities in response to revelations that several ANDA reviewers had accepted illegal gratuities from generic drug company executives. "Now that we have established an Office of Generic Drugs and Dr. Burlington and Mr. Fleischer have been collaterally assigned as the acting director and acting deputy director for bioequivalence, respectively, I want to delegate authorities to them so they may carry out their responsibilities," Peck stated in the Nov. 3 memo. Peck noted that a formal announcement will be published in the Federal Register. The authorities passed on to Burlington and Fleischer include sign-off responsibilities for citizens petitions, ANDAs, ANDA supplements, and 5-C NDAs as well as authority to determine ANDA submission dates and dates of effective approval. Peck said that Burlington and Fleischer would "have the same authority as permanent officials would have." Peck indicated that he would still like to keep his hand in the decisionmaking process in the Office of Generic Drugs. The memo notes: "I have asked Dr. Burlington and Mr. Fleischer to continue to discuss with me those actions that, in their judgement, involve a particular scientific or sensitive policy issue that they believe should have my personal attention." The internal announcement is an indication of the activity at FDA in preparation for Commissioner Young's upcoming appearance before Rep. Dingell's (D-Mich.) Energy & Commerce/Oversight Subcommittee on Nov. 17. Young is expected to provide an update on FDA's efforts to revamp its generic drug approval procedures. The creation of the Office of Generic Drugs and the management reorganization have been priority items in the agency's damage control for the generic scandal. The industry will be watching now to see if the rate of ANDA approvals picks up from the trickle of new generics that have come out of the agency in the past six months. In the month of October, FDA approved only two ANDAs.

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

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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