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New boss same as the old. FDA’s Office of Generic Drugs makes Kathleen Uhl permanent chief

By Kurt R. Karst –        The news came down on Thursday that FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., named Kathleen “Cook” Uhl, M.D., as the permanent director of the Office of Generic Drugs (“OGD”).  Although Dr. Uhl has manned the helm at OGD since March 2013 (see here), she has only done […]

By Kurt R. Karst –       

The news came down on Thursday that FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., named Kathleen “Cook” Uhl, M.D., as the permanent director of the Office of Generic Drugs (“OGD”).  Although Dr. Uhl has manned the helm at OGD since March 2013 (see here), she has only done so in an acting capacity.  She was tapped as Acting Director after the departure of Gregory P. Geba, M.D., who was OGD Director for only about nine months (see here).  OGD has done without a longstanding permament Director since Gary J. Buehler, RPh., left FDA in March 2010 for an industry position.  Keith Webber, Ph.D., who has also  since left FDA for a position in industry, filled in as Acting Director after Mr. Buehler’s departure.  A copy of Dr. Woodcock’s announcment of Dr. Uhl’s permanent position follows:

Dear Office of Generic Drugs Staff:

I am pleased to share with you the following news.  An announcement will be issued to all CDER staff today.

Kathleen “Cook” Uhl, M.D., has been named the permanent director of the Office of Generic Drugs (OGD). She brings to the position more than 30 years of regulatory and medical policy, scientific, and government leadership experience. 

I am confident in Cook’s continued exceptional leadership of OGD and its support of our Center’s mission.  She brings extensive knowledge and skills in developing and implementing standards for the safety and effectiviness of generic drugs. 

I would like to extend my sincere thanks to Cook for her outstanding work and service as acting director.  I would also like to thank all of you in OGD for your continued hard work and dedication to CDER’s mission during not only this leadership transition, but also the transition of OGD into a super-office.

Please join me in welcoming Cook to her permanent role.  Keep up the great work in OGD! 

Janet Woodcock

During her tenure as Acting Director, Dr. Uhl has overseen dramatic change within OGD, primarily as a result of FDA’s implementation of the Generic Drug User Fee Amendments of 2012.  This includes significant changes in OGD operations and personnel (see here and here) – including recent changes to the Office of Pharmaceutical Quality (see here) – as well as policy changes (not all of which have been welcomed by the generic drug industry) (see here). 

Dr. Uhl’s accession to permanent OGD Director signals Dr. Woodcock’s confidence in Dr. Uhl’s ability to man the OGD ship through the sometimes turbulent waters of GDUFA and generic drug approvals. 

Hyman, Phelps & McNamara's attorneys counsel and assist HPM clients in gaining government approvals for new products and in developing strategies to support successful marketing in accordance with the requirements of the law and the enforcement policies of FDA and other regulatory agencies.

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