Regulatory Focus™ > News Articles > Howard Sklamberg Promoted to Head of FDA Global Regulatory Operations; Third Leader in Past Year

Howard Sklamberg Promoted to Head of FDA Global Regulatory Operations Third Leader in Past Year

Posted 08 January 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced that Howard Sklamberg, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), has been promoted to the position of deputy commissioner for Global Regulatory Operations and Policy (GO).

The promotion is the second for Sklamberg in as many years, having last been promoted in November 2012 to director of the Office of Compliance. Prior to that promotion he served as deputy associate commissioner for regulatory affairs within the Office of Regulatory Affairs (ORA).

Within CDER, Sklamberg has played a central role in shaping how drugs are regulated, including the formation of a new Office of Pharmaceutical Quality (OPQ) within the center. The goal, Sklamberg told attendees at the 2013 RAPS Conference in Boston, MA, is to take a product lifecycle approach toward regulating products. Sklamberg has also been heavily involved in product surveillance, pharmaceutical compounding, globalization and contract manufacturing issues.

With FDA Deputy Commissioner John Taylor recently announcing his departure from the agency, the depth and breadth of Sklamberg's portfolio of responsibilities evidently made him the perfect match for a position that has already burned through two of FDA's top officials in the last year. In addition to Taylor, FDA also lost Deborah Autor, who left the agency in April 2013 to pursue opportunities at Mylan, a generic pharmaceutical manufacturer.

In an email to staff, FDA Commissioner Margaret Hamburg said that she was confident Sklamberg would provide "strong leadership," and said his experience was "well suited" to the position.

In addition to Sklamberg's experience as director of the Office of Compliance, he has also served at the US Attorney's Office, where he played a key role in prosecuting former FDA Commissioner Lester Crawford for misreporting conflicts of interest.

Sklamberg will assume the position of deputy commissioner immediately, Hamburg said.

Update: In an email to staff on 8 January, CDER Director Janet Woodcock said that Carol Bennett, now deputy director of the Office of Regulatory Policy (ORP), will serve as acting director of the Office of Compliance.

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