Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Wednesday, November 28, 2012
FDA Appoints New Director of Office of Compliance
Effective on or about Monday, Jan. 14, Howard Sklamberg, J.D., will become director of CDER's Office of Compliance.
Howard has served as the deputy associate commissioner for regulatory affairs in the Office of Regulatory Affairs (ORA) since 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. Howard played a key role in FDA’s response to the meningitis outbreak. In CDER, he will continue his role in developing new regulatory approaches to issues related to pharmacy compounding.
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, development and use of the Food Safety Modernization Act’s new enforcement tools, and critical assessment of the Mission Accomplishment and Regulatory Compliance Services system.
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.
He has a bachelor’s degree from Yale University, a juris doctor degree from Harvard Law School, and a master’s degree from the Fletcher School of Law and Diplomacy at Tufts University. From May 2010 to July 2011, he was director of ORA's Office of Enforcement. Before coming to FDA, he was a federal prosecutor, serving as an assistant U.S. attorney for the District of Columbia and as a trial attorney in the Justice Department's Public Integrity Section. He also served as deputy chief of the Fraud and Public Corruption Section of the U.S. Attorney's Office. Since 1999, Howard has been an adjunct professor at American University's Washington College of Law, where he teaches courses on Congressional investigations and white collar crime.
As FDA welcomes Howard to this position, Janet Woodcock would also like to thank Ilisa Bernstein for her leadership, expertise, and purposeful efforts to maximize our public health impact through strategic planning. She has served as acting director of CDER's Office of Compliance since August 2011, and she will resume her role as deputy director. Ilisa led the Office's transition into a super office, and 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.
As many of you know, Ilisa has a long and distinguished history at FDA. She joined FDA in 1988 as a clinical pharmacology reviewer in CDER. In 1991, she joined the Office of the Commissioner where she held several 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. I have greatly appreciated Ilisa’s positive and capable leadership during a very busy and demanding year.