Howard R. Sklamberg served from January 2014 to April 2017, as the Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), the directorate comprising the Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP).In this role, Howard provided executive oversight, strategic leadership and policy direction to many of the FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance and enforcement activities.
Howard played a key role in the implementation of the FDA Food Safety Modernization Act (FSMA) and collaboration with foreign and state regulators. He led the FDA delegation in bilateral and multilateral meetings with foreign countries, including Australia, Brazil, Canada, China, France, India, Ireland, Italy, Japan, Mexico and the United Kingdom, as well as the European Union.As Director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research (CDER), Howard led the office in its efforts to protect the American public from unsafe and ineffective drug products. He played key leadership roles in global drug supply chain security, pharmacy compounding oversight and pharmaceutical quality and he expanded cooperation with international regulatory partners.
Experience:
- Concentrates his practice on regulatory compliance and strategy related to food and drug law.
Representative Work:
- Deputy Associate Commissioner for Regulatory Affairs, FDA, 2011 to 2012.
- Director, Office of Enforcement, FDA, 2010 to 2011
- Deputy Chief, Fraud & Public Corruption Section, Office of the U.S. Attorney for the District of Columbia, 2007 to 2010.
- Assistant U.S. Attorney, Office of the U.S. Attorney for the District of Columbia, 1998 to 2002, 2005 to 2010.
- Trial Attorney, Public Integrity Section, Criminal Division, U.S. Department of Justice, 2002 to 2005.
- Minority Counsel, Special Investigation of the 1996 Election Campaign, Committee on Governmental Affairs, U.S. Senate, 1997 to 1998.
- Deputy Commissioner for Global Regulatory Operations and Policy, FDA, 2014 to 2017.
- Director, Office of Compliance, Center for Drug Evaluation and Research, FDA, 2013 to 2014.
Affiliations:
- Director of the Office of Compliance, FDA Center for Drug Evaluation and Research, 2013 to 2014.
- Deputy Associate Commissioner for Regulatory Affairs, 2011 to 2013.
- Barrister, Edward Bennett Williams Inns of Court.
- Deputy Commissioner for Global Regulatory Operations, FDA, 2014 to 2017.
Education:
- J.D., Harvard Law School, 1995
- M.A.L.D., Tufts University, 1994
- B.A., Yale University, 1991
Bar Admissions:
- District of Columbia
- New York
Cost
Rate : $$$
