Pink Sheet is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

FDA OFFICE OF GENERIC DRUGS: ACTING DIRECTOR IS BRUCE BURLINGTON, MD

Executive Summary

FDA OFFICE OF GENERIC DRUGS: ACTING DIRECTOR IS BRUCE BURLINGTON, MD, who takes on the new responsibilities with previous experience in the Office of Drug Evaluation II and the Center for Biologics. Center for Drug Evaluation and Research Director Carl Peck, MD, announced Burlington's appointment to the newly established Office of Generic Drugs in an Oct. 3 memo to FDA staff. Burlington has been serving as deputy director (under James Bilstad) for the Office of Drug Evaluation II for about one year. Nicholas Fleischer, acting chief of the scientific support branch in the Division of Biopharmaceutics, was appointed to the position of acting deputy director for the Office of Generic Drugs. Both Burlington and Fleischer will keep their current agency titles while switching to the generic drug duties. Peck said that "in consideration of the important current responsibilities of these individuals, their initial assignment to this activity will be as a collateral duty on a part-time basis." The new generics office was established by the agency in early August as a structural response to the investigations of generic application fraud. It is composed of two divisions, the Division of Generic Drugs and the Division of Bioequivalence, which were previously under the purview of the Office of Drug Standards. FDA noted that it is not making substantial changes to the personnel in the two divisions. Prior to his position in ODE II, Burlington served as director of the Division of Biological INDs for three years. During his last year in INDs, Burlington also acted in an administrative capacity in the Office of Biological Product Review. Fleischer is a pharmacist working toward a PhD in clinical pharmacology at the Uniformed Services University. * Recently-released figures from the Division of Generic Drugs show that for the fiscal year ended Sept. 30, the division approved a total of 289 ANDAs. This number represents a dramatic decrease, by more than half, from the number of ANDAs (641) approved in fiscal year 1988. There was similar decline in the number of abbreviated antibiotic applications approved, 68 versus 133 in the previous year. The slowdown in the number of generic drug approvals is accompanied by a smaller drop in the number of applications. In FY 1989, there was a drop in the number of original ANDAs received by the division. A total of 796 applications were received this year, while 829 were submitted in fiscal 1988. The number of ANDAs submitted to FDA this year began slacking off significantly starting in May. In April, 70 applications were filed and, in May, 45 ANDAs were submitted. The number of ANDA applications that have gone past the statutory requirement of reviewing applications in 180 days, increased as the year progressed. There is a total of 545 such applications now pending.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS016350

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

Cancel