Caroline D. Kessler, Associate, Health

Caroline D. Kessler

Associate

Areas of Focus

Caroline D. Kessler, Associate, Health

Caroline D. Kessler

Associate

ckessler@akingump.com

Areas of Focus

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Biography
  • Practice focuses on regulatory issues in the health care sector.
  • Assists clients with complex FDA drug, biologic and device regulatory matters.
  • Advises on matters related to Medicare and Medicaid reimbursement.

Caroline Kessler advises a variety of companies in the U.S. health care industry. Her clients include hospitals and health systems, academic medical centers, and pharmaceutical and device companies. She focuses on regulatory and transactional matters related to food and drug law, as well as Medicare and Medicaid reimbursement.

Caroline assists clients in the pharmaceutical, biotechnology, medical device and food industries with complex matters relating to government regulation implemented by the U.S. Food and Drug Administration (FDA). Her work primarily includes advising clients with respect to laws and regulations related to the development and commercialization of pharmaceutical products, medical devices and other health technologies, including FDA labeling and promotional matters.

Additionally, Caroline represents health care providers and other clients in connection with health care policy implemented by the Centers for Medicare and Medicaid Services (CMS).

Prior to attending law school, Caroline was a staff member in the office of Sen. Angus S. King, Jr. (I-ME), as well as at the Harvard T.H. Chan School of Public Health.

While in law school, Caroline served as an executive editor of the Virginia Law Review and as the president of the Health Law Association. She also interned with the Vaccine Litigation Unit in the U.S. Department of Justice.

Caroline was a member of Akin’s 2018 summer associate class.

Representative Work
  • Advising clients in the pharmaceutical, device and food industries regarding compliance with FDA regulations.
  • Assisting a variety of clients with the FDA submission process as well as general FDA regulatory strategy and engagement.
  • Counseling a pharmaceutical company regarding the implications of Medicare and Medicaid payment policies and state laws impacting patient access to pharmaceuticals, including biosimilars and unbranded biologics.
  • Advising clients on the implications of state and federal laws related to controlled substances.
  • Engaging CMS on issues related to Surprise Billing.
  • Helping clients respond to data breaches, including evaluating whether breach notification requirements under state and federal law have been triggered.

Education
  • J.D., University of Virginia School of Law, 2019

  • B.A., Vassar College, 2012

Bar Admissions
  • District of Columbia

  • Massachusetts

Affiliations and Public Service
  • Staff member, office of Sen. Angus S. King, Jr. (I-ME)
  • Legal intern, U.S. Department of Justice, Civil Division.
  • Member, American Health Lawyers Association.

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