The appointment of FDA Deputy Associate Commissioner for Regulatory Affairs Howard Sklamberg as the Center for Drug Evaluation and Research’s new compliance head gives the Office of Compliance permanent leadership in the midst of ongoing fallout from the pharmacy compounding-related meningitis outbreak.

Sklamberg, who is expected to assume the position as Office of Compliance director on Jan. 14, brings experience dealing with compounding-related issues, including those involving the New England Compounding Center, FDA said.

CDER Director Woodcock highlighted Sklamberg’s work in response to the meningitis outbreak resulting from contaminated, compounded drugs.

Painkiller injections manufactured by NECC have been linked to more than 500 cases of fungal meningitis and 36 deaths in the U.S. The outbreak has focused new scrutiny on the roles of FDA and states in regulating the practice of pharmacy compounding.

Sklamberg take over the compliance office’s leadership role from Ilisa Bernstein, who has served as acting director since 2011. She will resume her role as a deputy director.

Bernstein was tapped to fill the void created when then-director Deborah Autor was named to the position of deputy commissioner for global regulatory operations and policy, a move that was part of larger structural reorganization undertaken by Commissioner Margaret Hamburg Also see "FDA Reorganization Adds "Directorate" Layer, But Sharpens Agency's Focus" - Pink Sheet, 18 July, 2011..

Compounding Experience Is A Focus

In a Nov. 28 email announcing Sklamberg’s appointment, CDER Director Janet Woodcock highlighted his experience on compounding issues and indicated this is an area on which he will continue to focus.

As deputy associate commissioner for regulatory affairs, “Howard played a key role in FDA’s response to the meningitis outbreak,” Woodcock said. This work has included participating in an Oct. 26 media call to discuss FDA’s issuance of a Form 483 following an inspection of NECC’s facility. He also attended recent congressional hearings at which Commissioner Margaret Hamburg asked lawmakers to give the agency more authority to regulate drug compounders ([A#00121119013]).

At CDER, Sklamberg “will continue his role in developing new regulatory approaches to issues related to pharmacy compounding,” Woodcock said.

These approaches include better delineating the roles of FDA and the states in regulating compounding pharmacies. FDA is convening a Dec. 19 intergovernmental meeting with state representatives on this issue ([A#14121127007]).

Bernstein also will stay active in the agency’s response to the NECC crisis, Woodcock said. “She will continue to play a key role in the Agency’s efforts on the recent meningitis outbreak and the associated recalls of compounded drugs.”

Woodcock thanked Bernstein for her “leadership, expertise and purposeful efforts to maximize our public health impact through strategic planning.” She also noted that Bernstein led the compliance office’s transition into a “super office” within CDER Also see "CDER’s Drug Integrity Program Gains Formal Role In Compliance Office Reorg" - Pink Sheet, 13 June, 2011..

Bernstein is a 24-year agency veteran, rising through the ranks from a pharmacology reviewer in CDER to the Office of the Commissioner, where she held a variety of positions, including director of pharmacy affairs. “She has successfully collaborated with others in FDA, as well as with our external partners and stakeholders, to ensure that FDA’s goals of minimizing consumer exposure to unsafe, ineffective, and poor-quality drugs are efficiently and effectively met,” Woodcock said. “I have greatly appreciated Ilisa’s positive and capable leadership during a very busy and demanding year.”

Leveraging Prosecutorial Experience

Sklamberg is a former federal prosecutor whose FDA tenure has been brief but varied in terms of the issues on which he was worked.

He joined FDA in May 2010 as director of ORA’s Office of Enforcement and assumed the role of deputy associate commissioner in July 2011. “In this role, he provided executive leadership, management and direction to a variety of functions such as criminal investigations, information technology, policy and risk management, partnerships, communications, quality management and the executive secretariat,” Woodcock’s email states.

The CDER director’s announcement lists a host of specific initiatives in which Sklamberg has been involved during his two-and-a-half years in ORA. These include streamlining processes for seizures and injunctions, improvements in the product recall process, a critical assessment of the Mission Accomplishment and Regulatory Compliance Services system, development and use of the Food Safety Modernization Act’s new enforcement tools, and improvements in federal-state relationships for the foods program.

Woodcock also highlighted Sklamberg’s experience in dealing with public health issues.

“Howard has contributed significantly to the management of many major public health and policy issues raised within ORA during his tenure, including the Case for Quality Initiative for medical devices, issues related to McNeil inspections and heparin, counterfeit drugs and dietary supplements, an Office of the Inspector General study on state contract food facility inspections, drug shortages, and enforcement related to raw milk and carbendazim in imported orange juice.”

Sklamberg holds a bachelor’s degree from Yale University, a law degree from Harvard, and a master’s degree from Tufts University. Before joining FDA he was an assistant U.S. Attorney for the District of Columbia, a trial attorney in the Justice Department’s Public Integrity Section and deputy chief of the Fraud and Public Corruption Section of the U.S. Attorney’s Office.

More Transitions For ORA

Sklamberg’s move to CDER comes on the heels of an ORA reorganization aimed at better addressing the agency’s new legislative authorities and the increasingly globalized nature of foods and medical products Also see "FDA Office of Regulatory Affairs Make-Over Blends Domestic, International Work" - Pink Sheet, 8 October, 2012..

FDA said Sklamberg’s replacement at ORA has not yet been named. However, his imminent departure means ORA’s top two positions could be filled by staff serving in an acting capacity pending permanent appointments.

Sklamberg’s boss currently is Melinda Plaisier, who took over as acting associate commissioner for regulatory affairs following the departure of Dara Corrigan to head FDA’s Europe office Also see "FDA Associate Commissioners Transition As PDUFA IV Rolls Over To V" - Pink Sheet, 13 September, 2012..

CDER’s New Compliance Director Sklamberg Brings Experience On Compounding Issues

More from United States

More from North America