Bonnie Odom’s experience includes:
- Conducting health regulatory due diligence for transactions involving life sciences companies
- Providing advice to pharmaceutical and device manufacturers on U.S. Food and Drug Administration (“FDA”) compliance matters, including FDA premarket clearance and approval strategies and advertising and promotion issues
- Advising mobile app companies and other new entrants to the FDA-regulated environment in understanding and navigating applicable regulatory requirements
- Serving as legal counsel to the Combination Products Coalition (“CPC”), a group of leading pharmaceutical, device, and biologics manufacturers focused on regulatory issues impacting combination products
- Counseling hospitals and other health care providers in the areas of federal and state health care fraud and abuse issues, including anti-kickback and self-referral claims
- Assisting pharmaceutical companies in drafting and negotiating clinical trial agreements and maintaining clinical research compliance
- Advising clients on regulatory compliance related to the use of telehealth
In 2016, Bonnie served as a contributing author of Epstein Becker Green’s 50-State Survey of Telemental/Telebehavioral Health, detailing the rapid growth of telemental health—mental health care delivered via interactive audio or video, computer programs, or mobile applications—and the increasingly complex legal issues associated with this trend. She is also a contributor to the Health Law Advisor Blog.
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; a health care reimbursement consultancy serving hospitals in Connecticut, New Jersey, New York, and Pennsylvania; and the Arthritis Foundation in Washington, DC. Bonnie is a recipient of George Washington University’s Outstanding Academic Achievement Award.