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Howard Sklamberg

FDA Compliance

Building Expertise and Crossing Boundaries to Improve Oversight

Keeping pace with the scientific innovation and global expansion of markets is an FDA priority

Published: Monday, June 2, 2014 - 12:49


To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world.

As the Food and Drug Administration’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee the FDA’s efforts to further advance its thinking and strategies from primarily domestic to a globally focused regulator.

GO coordinates the efforts of the FDA’s Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP), and works with all of the FDA’s product centers on scientific, manufacturing, or other regulatory challenges. The highly skilled and dedicated workforce in ORA and OIP is responsible for conducting domestic and foreign inspections; deepening collaborations with local, state, and foreign regulatory partners; helping these regulatory partners to strengthen their regulatory systems; and fostering the use of science-based standards and regulatory coherence worldwide to promote public health.

We have to be able to share information with our regulatory partners. We need their help to implement new regulations that have global impact on the oversight of food under the Food Safety Modernization Act and medical products under the Food and Drug Administration Safety and Innovation Act. Working together with these partners, we can ensure an effective public health safety net for our citizens and communities.

An important priority for the FDA is to make fundamental changes to the way we operate and align our efforts agencywide to keep pace with scientific innovation and the global expansion of markets. So much of the FDA’s work cuts across multiple product areas; how do we make that work as a large and complex agency?

Enhanced specialization

Commissioner Hamburg and senior leaders throughout the agency are committed to strengthening our ability to do just that and are collaborating to achieve greater operational and program alignment across the centers and the ORA. A key part of this process is to enhance specialization across the FDA. For ORA, enhanced specialization means that investigators, compliance officers, import reviewers, laboratory personnel, managers and others will have increased technical expertise in a specific commodity area and will work closely with subject matter experts in the FDA’s centers. Over time, ORA’s geographic-based model will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco. They will work as part of a team with staff from other centers, collaborating, for example, with the Center for Drug Evaluation and Research on pharmaceutical oversight or with the Center for Food Safety and Applied Nutrition on food safety issues.

It’s especially important that experts in the centers and ORA be engaged in helping to develop compliance policies and priorities. Working with the centers on these broader concerns puts ORA investigators and compliance officers in a better position to implement the preventive approaches contained in new statutes and work more seamlessly with the centers.

These and other changes that are part of the agency’s focus on program alignment will deepen our knowledge and make us more effective and efficient, with more clarity and coherence in our communications and actions.

This process is still in its early stages. There is a lot of planning still to be done, and we will work to ensure a transparent and inclusive process. Nevertheless, change is coming and I am excited and proud to be part of a transformation that can only strengthen our efforts to safeguard the foods and medical products that are so important to people all over the world.

First published May 9, 2014, on FDAVoice.


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About The Author

Howard Sklamberg’s picture

Howard Sklamberg

Howard Sklamberg is FDA’s deputy commissioner for global regulatory operations and policy, and he is the directorate comprising the Office of Regulatory Affairs and the Office of International Programs. Sklamberg provides executive oversight, strategic leadership, and policy direction to 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. Sklamberg played leadership roles in global drug supply chain security, pharmacy compounding oversight, pharmaceutical quality, and expanded cooperation with international regulatory partners. Sklamberg has degrees from Harvard Law School, Yale University, and Fletcher School of Law and Diplomacy.