Afia Asamoah helps biopharmaceutical and medical device clients successfully navigate the FDA regulatory process governing development and approval of medical products and advises clients on mergers and acquisitions and licensing deals in the life sciences industry. Ms. Asamoah has particular experience working with companies and trade associations on legislative and policy matters relating to FDA’s regulation of medical products. Ms. Asamoah is a regular contributor to the firm's "InsideMedical Devices Blog."
From May 2009-January 2011, Ms. Asamoah worked with senior leaders and staff in the Office of the Commissioner at the U.S. Food and Drug Administration. She participated in developing the strategy for FDA enforcement activities and helped create the new FDA center to regulate tobacco products. As leader of the agency-wide Transparency Initiative, Ms. Asamoah worked to improve the transparency and predictability of the FDA regulatory process and spur product innovation. Ms. Asamoah received four FDA awards during her tenure at the agency, including the FDA Commissioner’s Special Citation “for strong leadership and innovative management of the FDA Transparency Initiative and Task Force."
Successfully compelled FDA to take action against competitor that was improperly promoting its diagnostic device product.
Developed strategies and drafted position papers on ways to improve the FDA drug approval process and created arguments used by lobbyists in advocating for the proposals on the Hill.
Helped client execute strategy to avoid negative regulatory implications from market withdrawal of a multimillion dollar prescription drug.
Helped major pharmaceutical company organize and execute regulatory effort to protect multimillion dollar innovative drug from premature generic competition.
Successfully represented major pharmaceutical company facing government investigation by the U.S. Attorney’s Office in the Southern District of New York that resulted in the government declining to prosecute the case.
Advised US-based medical device company that successfully acquired a wireless communication system.
Developed strategies and drafted position papers on significant issues on FDA docket (scientific exchange, responding to unsolicited requests, prescription/OTC switches, dissemination of treatment guidelines, dissemination of pharmacoeconomic data, disease awareness communications).
More Representative Matters
U.S. Food and Drug Administration, Office of the Commissioner, Special Assistant
House Oversight and Government Reform Committee, Public Health Fellow
Health Leads (formerly Project HEALTH), Regional Coordinator
Medicare Rights Center, Health Advocacy Fellow
HONORS AND RANKINGS
Received FDA Commissioner’s Special Citation for strong leadership and innovative management of FDA Transparency Initiative.
Received 3 FDA recognition awards for work on FDA enforcement team, improving transparency of FDA’s regulatory process, and development of new FDA Center to regulate tobacco products.
Successfully represented client in administrative hearing regarding overpayments.
MEMBERSHIPS AND AFFILIATIONS
ABA Health Law Section, Public Health and Policy Interest Group, Vice Chair
ABA Science & Technology Law Section, Medical Devices Committee, Co-Chair
New York City Bar, Health Law Committee, Member
Health Leads, Board Member
PUBLICATIONS AND SPEECHES
"Tips and Tactics to Assure Compliance with FDA Financial Disclosure Requirements for Clinical Investigators," FDANews Webinar (3/27/2013)
"Clinical Trial Developments in 2012," Covington E-Alert (2/1/2013), Co-Author
"Raising the Evidence Bar for Biotech: What Will FDA Changes and Increased Payer Scrutiny Mean," Biotech Showcase 2013 (1/9/2013)