Caroline D. Kessler
Associate
Areas of Focus
- Health Care & Life Sciences
- Food & Drug Law
- Cannabis Compliance & Policy
- Health Care Regulatory Compliance Counseling
- Health Care Reimbursement
- Health Policy & Legislation
- Health Care Innovations
- Regulatory
- Health Information Privacy & Security
- Technology
- Artificial Intelligence & Machine Learning
- 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.
- 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.
EducationJ.D., University of Virginia School of Law, 2019
B.A., Vassar College, 2012
J.D., University of Virginia School of Law, 2019
B.A., Vassar College, 2012
Bar AdmissionsDistrict of Columbia
Massachusetts
District of Columbia
Massachusetts
- 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.