FacultyFaculty/Author Profile
Afia K. Asamoah

Afia K. Asamoah

Covington & Burling LLP

New York, NY, USA


Afia Asamoah is an associate in the firm's Healthcare and Food & Drug practice groups.  Ms. Asamoah advises clients on matters relating to the regulation of pharmaceuticals, biological products, and medical devices, and she provides advice to companies regarding interactions with FDA.

Ms. Asamoah's recent matters include adverse event reporting, advertising and promotion of prescription and OTC drugs, FDA's accelerated approval pathway, responding to unsolicited requests, dissemination of healthcare economic information, biosimilars, imports and exports, conduct of clinical trials, FOIA, pharmacy compounding, Rx/OTC switches, regulatory due diligence for corporate acquisitions involving medical devices, drugs, and biological products, and legislative activities.

From May 2009 - January 2011, Ms. Asamoah served as the Special Assistant to the Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA).  Ms. Asamoah provided guidance, strategic advice, and operational management to the Commissioner, Principal Deputy Commissioner and senior management on significant regulatory and policy matters across all FDA-regulated product areas, including medical product and food safety, enforcement and compliance activities.  As leader of the agency-wide FDA Transparency Initiative, Ms. Asamoah's work resulted in an agency disclosure policy that outlines a path for FDA to spur product innovation and advance public health via improved transparency.  Ms. Asamoah received numerous awards during her tenure at the agency, including the FDA Commissioner's Special Citation Award/Harvey Wiley Award "for strong leadership and innovative management of the FDA Transparency Initiative and Task Force."


PREVIOUS EXPERIENCE

  • U.S. Food and Drug Administration, Special Assistant, Office of the Commissioner (2009-2011)
  • House Oversight and Government Reform Committee, Public Health Fellow (Summer 2004)
  • Project HEALTH, Regional Coordinator (2000-2001)
  • Medicare Rights Center, Health Advocacy Fellow (1999-2000)


HONORS AND RANKINGS

  • FDA Group Recognition Award for exceptional success completing FDA's action against caffeine in alcoholic beverages (2011)
  • FDA Commissioner's Special Citation for strong leadership and innovative management of the FDA Transparency Initiative and Task Force (2010)
  • FDA Group Recognition Award for excellent work on the FDA Basics web resource as part of the Transparency Initiative (2011, 2010)
  • FDA Group Recognition Award for outstanding teamwork and dedication leading to the development, drafting, and implementation of new legislation to regulate tobacco products (2010)


PRO BONO

  • Represent client in Supplemental Security Income overpayment administrative hearing.


MEMBERSHIPS AND AFFILIATIONS

  • Vice Chair, Public Health and Policy Interest Group, ABA Health Law Committee
  • New York City Bar, Health Law Committee
  • Co-Chair, Medical Devices Committee, ABA Science & Technology Law  
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