Anna Abram, Senior Advisor, Health Care Policy & Legislation

Anna K. Abram

Senior Advisor

Areas of Focus

Anna Abram, Senior Advisor, Health Care Policy & Legislation

Anna K. Abram

Senior Advisor

aabram@akingump.com

Areas of Focus

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Biography
  • Recognized health care policy thought leader with over two decades of experience shaping U.S. health policy.
  • Extensive experience in FDA policy having served in the senior leadership role of Deputy Commissioner for Policy, Legislation, and International Affairs at the Food and Drug Administration (FDA) and as an Associate Director at The White House Domestic Policy Council.
  • Brings more than a decade of Capitol Hill experience having served as the Health Policy Director and Senior Advisor to Sen. Richard Burr (R-NC) and working at the Senate Health, Education, Labor and Pensions (HELP) Committee on health policy issues spanning the HELP Committee, and the Senate Finance Committee, to provide strategic advice to and advocacy on behalf of clients.
  • Recognized as a ‘Top Lobbyist’ by the National Institute for Lobbying & Ethics in 2022 and 2023 for her exceptional advocacy and impact.

With more than two decades of distinguished experience at the highest levels of government and federal advocacy, Anna is a trusted advisor known for her leadership in crafting policy and navigating the policy making process to achieve results on a range of complex health care, life science and public health challenges. Throughout her career, she has advanced patient-focused and public health policy outcomes.

In her current role at Akin, Anna applies her extensive experience in health policy, legislative dynamics and regulatory frameworks to advise and advocate on behalf of clients in the health care and life sciences sectors. Whether advising on FDA regulatory strategies, guiding legislative campaigns or facilitating engagement with key policymakers in Washington, Anna’s strategic foresight, insights, and practical advice ensure that her clients are well supported in an ever evolving and increasingly complex policy environment.

Anna’s ability to align business objectives with public policy goals has made her an invaluable resource for clients navigating high-stakes issues. Anna's hands-on approach, seasoned knowhow and ability to anticipate political trends position her clients to achieve tangible results.

Anna’s tenure as Deputy Commissioner for Policy, Legislation, and International Affairs at the FDA underscores her reputation as a leader in public health policy. As Deputy Commissioner, Anna played a critical role in overseeing the development and implementation of key policy initiatives and provided strategic policy direction to advance FDA’s public health mission. In addition to her senior FDA role, Anna's service at The White House Domestic Policy Council provided her with key experience navigating the policymaking process at the highest levels of the federal government, where she coordinated the development and implementation of a range of health care policy issues, including food, drug and public health policy, and The White House-led, interagency policy process to reauthorize the President’s Emergency Plan for AIDS Relief (PEPFAR) in 2008.

A hallmark of Anna’s career is her ability to build bipartisan coalitions, advancing reforms that cross political divides and branches of government. She was instrumental in the bipartisan negotiation and enactment of the most significant security enhancements to the United States’s pharmaceutical supply chain in the past 25 years through the Drug Quality and Security Act (DQSA). She also played a key role in the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), which bolstered the nation’s medical countermeasures and emergency preparedness systems.

Anna brings extensive legislative experience from her time as Health Policy Director and Senior Advisor to Senator Richard Burr and working at the Senate HELP Committee. Anna’s contributions to advancing bipartisan FDA and medical and public health preparedness and response legislation were notable and numerous during her tenure in the Senate, including securing multiple patient-centered drug and device provisions in the Food and Drug Administration Safety and Innovation Act and 21st Century Cures Act.

Representative Work
  • Led high-profile and significant policy, regulatory initiatives and engagements related to a range of policy matters, including drug competition, drug compounding, agricultural biotechnology, food policy, medical countermeasures and tobacco policy, with notable interagency collaborations with the U.S. Department of Defense and the U.S. Department of Agriculture.
  • Led FDA’s legislative strategy for significant public health legislation, including the FDA Reauthorization Act of 2017, the SUPPORT for Patients and Communities Act, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 and Over-the-Counter Drug Monograph reform.
  • Spearheaded the bipartisan negotiation and enactment of the most significant security enhancements to the U.S. pharmaceutical supply chain in 25 years through the Drug Quality and Security Act.
  • Successfully negotiated the introduction and enactment of the bipartisan Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).
  • Secured multiple provisions in the 2012 FDA user fee reauthorization and 21st Century Cures Act to advance medical product innovation on behalf of patients and strengthen public health.

List may include matters worked on prior to joining Akin.

Education
  • B.A., University of Pennsylvania, Magna Cum Laude, 2003

Recognitions
  • National Institute for Lobbying & Ethics, Top Lobbyists, 2022-2023.
Affiliations and Public Service
  • Deputy Commissioner for Policy, Legislation and International Affairs, U.S. Food and Drug Administration (2017-2021).
  • Health Policy Director and Senior Advisor (along with other roles) to Sen. Richard Burr, Senate HELP Committee, U.S. Senate (2009-2017).
  • Associate Director, Domestic Policy Council, The White House (2007-2009).
  • Legislative Aide (along with other roles), Office of Sen. Rick Santorum, U.S. Senate (2003-2006).
Speeches and Publications
  • Panelist, BIO's IP Counsels Committee Conference 2024 “Biosimilars: Patents, Regulations, Litigation” Washington, D.C., November 2024.
  • Panelist, America's Physician Groups Fall Conference 2024 “After the Supreme Court’s Chevron Decision: What’s Next for Federal Health Care Legislation and Regulation?” Washington, D.C., November 2024.
  • Panelist, NC Life Sciences Organization “Diagnostic Testing: Will FDA’s Final Rule be the Final Word”, Durham, NC, May 2024.
  • Moderator, ACI 14th Summit on Biosimilars & Biologics “The Inflation Reduction Act: Understanding the Impact on Biologic Innovation and the Biosimilar Marketplace” panel, Boston, MA, June 2023.
  • “User fee hiring: CBER on track while CDER lags,” quoted in Regulatory Focus, April 2023.
  • Speaker, NC Biosciences Organization, “CEO Roundtable: Preparing for Price Setting under the Inflation Reduction Act”, Durham, NC, February 2023.
  • Key Senate health committee could be led by Paul, Sanders in 2023, quoted in National Journal, August 2022.
  • Speaker, American Society of Gene & Cell Therapy Annual Meeting “Overview of the Accelerated Approval Pathway: Definitions, Legislative History, and Purpose”, Washington, D.C., May 2022.
  • Speaker, Alliance for Health Policy “Health Policy Roundup: Background on FDA User Fee Programs”, Washington, D.C., February 2022.
  • “F.D.A. Still Lacks a Permanent Commissioner,” quoted in The New York Times, June 2021.

Insights and Achievements

    Publications | Alerts

    November 15, 2024

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      Publications | Alerts

      November 15, 2024

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          Publications | Alerts

          November 15, 2024

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            Publications | Alerts

            November 15, 2024

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