Bonnie Odom

Life sciences, health care, and technology companies, as well as investors, turn to attorney Bonnie Odom to identify regulatory, contracting, fraud and abuse, and licensure risks and to get practical advice on navigating them while achieving their business goals.

From development through commercialization, pharmaceutical and medical device companies rely on Bonnie for advice on FDA regulatory and quality compliance. She frequently helps software as a medical device (“SaMD”) companies, including those developing AI-enabled products, and other new entrants to the FDA-regulated environment understand the regulatory status of their products and comply with applicable requirements. Clients also engage her to review advertising and promotional materials, respond to FDA Form 483 observations and FTC inquiries, and develop and implement remediation strategies.

Bonnie has extensive experience drafting and negotiating agreements for complex commercial arrangements involving life sciences companies. Across supply, quality, distribution, and other commercial agreements, she focuses on clearly allocating regulatory and quality responsibilities and securing privacy, IP, liability, and other key protections for clients. A practical, business-minded approach runs through this work: Bonnie pushes for the protections that matter most to clients, weighs commercial realities, and works closely with client teams to move contracts and key decisions forward.

Alongside this contracting work, Bonnie counsels clients on federal and state health care fraud and abuse issues, including anti-kickback and self-referral law compliance. Drawing on this experience, she conducts compliance program effectiveness reviews and gap analyses against OIG guidance and industry best practices, and helps clients develop and strengthen compliance policies, procedures, and other program elements. She also assists clients in assessing whether reporting requirements under the federal Physician Payments Sunshine Act (implemented through the Open Payments program) and state transparency laws apply to their business. She helps implement solutions to achieve and maintain compliance.

Clients also rely on Bonnie for her deep experience advising on state board of pharmacy licensure matters, including addressing board enforcement issues. In life sciences transactions, she assesses the adequacy of target license portfolios, coordinates the filings needed to avoid operational disruptions after closing, and supports ongoing state licensure compliance. She also has broad health regulatory due diligence experience extending well beyond licensure. She routinely helps private equity clients considering investments in health care and life sciences companies assess the full scope of relevant health regulatory risks.

In addition, Bonnie serves as lead counsel to the Combination Products Coalition (“CPC”), a group of leading pharmaceutical, device, and biologics manufacturers focused on FDA-facing advocacy to improve the regulatory environment for combination products, and has supported the CPC’s work for more than a decade.

Bonnie co-authors periodic updates to the “In Vitro Diagnostic (IVD) Devices” chapter of the Medical Devices Law and Regulation Answer Book, published by the Practising Law Institute (PLI).

While at law school, Bonnie was a Notes & Comments Editor of the Emory Law Journal and served as an administrative intern at The Emory Clinic in Atlanta, Georgia. She also worked as an intern at the Office of General Counsel, U.S. Department of Health and Human Services, in Atlanta, and at a health care reimbursement consultancy serving hospitals in Connecticut, New Jersey, New York, and Pennsylvania. Bonnie is a recipient of George Washington University’s Outstanding Academic Achievement Award.

• The Best Lawyers in America^©: “Ones to Watch” in Health Care Law (2024 to 2025)

Education

• Emory University School of Law (J.D., with honors, 2012)
• Emory University (M.P.H., 2012)
• The George Washington University (B.S., summa cum laude, 2009)

Professional & Community Involvement

• American Health Lawyers Association
• Strategic Committee Member, AFDO/RAPS Combination Products Summit