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Office of the Chief Medical Officer Also referred to as: OCMO

Mission

Support medical product development and availability, promote patient and consumer health and advance innovative clinical research.

What We Do

The Office of the Chief Medical Officer (OCMO) provides executive leadership, coordination, and oversight of FDA cross-cutting clinical and public health emergency-related regulatory policy matters, and public health preparedness and response activities on behalf of the Commissioner. OCMO promotes the development of safe, effective, and innovative medical products for patients by facilitating agency-wide collaboration on combination products, improving evidence generation practices, overseeing ethical conduct of clinical research, advancing the development of new treatments for rare diseases, assuring children have access to safe and effective medical products, and facilitating development and availability of medical countermeasures. OCMO fosters clinical community of practice and related career development across the agency and serves as primary liaison to clinical organizations. 

Who We Are

Key Priorities

  • Advance clinical policy related to medical product development and regulation including improving design and transparency of clinical research, and policy related to research participants (e.g., participant-centric informed consent). 

  • Advance the development of safe, effective, and innovative medical products to address unmet needs for patients such as children (including newborns) and patients with rare diseases (e.g., ALS and Huntington’s disease). 

  • Enhance the clarity, predictability, efficiency, and consistency of premarket and postmarket regulatory expectations for combination products. 

  • Enhance outreach to and collaboration with sponsors of medical products and international regulators to advance international harmonization of regulatory standards related to the office’s portfolios.  

  • Lead the FDA’s medical countermeasure portfolio through coordinated policy implementation of U.S. government national and global health security strategies and priorities. Also serves as the agency’s lead for public health readiness and response to outbreaks, epidemics, and pandemics (e.g., avian flu, mpox). 

  • Coordinate FDA policy and response to product shortages, including interagency collaboration to support improved supply chain resiliency. 

Connect with OCMO

For clinicians: Join FDA Chief Medical Officer Hilary Marston, M.D., M.P.H., for Clinicians Connect, a series of clinically focused conversations on a variety of public health topics. For more information, subscribe to the Clinicians Connect mailing list.   

Contact Us

Office of the Chief Medical Officer
U.S. Food and Drug Administration
10903 New Hampshire Ave, WO-32
Silver Spring, MD 20993

ChiefMedicalOfficer@fda.hhs.gov 



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