Woodcock Announces New Leader for CDER Compliance Office

Posted 29 November 2012 | By Alexander Gaffney, RAC 

One of FDA's top pharmaceutical regulatory officials is getting a promotion.

In an email sent to staff on Wednesday, 28 November, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), announced the promotion of Howard Sklamberg, JD, to the position of director of CDER's Office of Compliance (OC).

Sklamberg will assume the OC position on 14 January 2013, Woodcock wrote. He currently serves as deputy associate commissioner for regulatory affairs within FDA's Office of Regulatory Affairs (ORA), where he has served since July 2011.

"Howard's efforts within ORA led to improvements in federal-state relationships for the Foods program, streamlining of the Agency's approval process for seizures and injunctions, improvements to the Agency's recall process … and critical assessment of the Mission Accomplishment and Regulatory Compliance Services system," Woodcock explained.

Sklamberg has also been deeply involved with FDA's "Case for Quality" initiative, a medical device-focused undertaking aimed at shifting to a new compliance approach emphasizing broader quality issues rather than stand-alone compliance issues. In presentations to the Regulatory Affairs Professionals Society (RAPS), the agency has said the initiative could eventually come to include pharmaceutical products. With Sklamberg now heading up the top regulatory compliance job in CDER, that shift could occur more easily.

For now, however, Sklamberg will likely find much of his energies focused on the pharmaceutical compounding crisis now threatening both patients and FDA's reputation. "Howard played a key role in FDA's response to the meningitis outbreak," Woodcock explained. "In CDER, he will continue his role in developing new regulatory approaches to issues related to pharmacy compounding."

Those new approaches were outlined by FDA Commissioner Margaret Hamburg in testimony on 14 November to the US House of Representatives, and include a new, two-category framework under which compounders would operate and categories of drugs that compounders would be banned from manufacturing.

The current acting director of CDER's OC, Ilisa Bernstein, will resume her role as deputy director of the office and will "continue to play a key role in the Agency's efforts on the recent meningitis outbreak" as well, Woodcock wrote.

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