Kellie Combs is the chair of the firm’s global life sciences regulatory and compliance practice group and a co-chair of the firm’s cross-practice digital health initiative. Kellie provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers, as well as health care providers and academic institutions, on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She has extensive experience handling matters implicating FDA promotional rules and the First Amendment and also advises clients on FDA regulatory strategy, regulation of digital health tools, drug and biologic exclusivity, expedited development and approval programs, and post-approval compliance. In addition, she routinely conducts regulatory due diligence and negotiates key regulatory deal terms in connection with a wide variety of transactions involving drug, device, dietary supplement, cosmetic, and other consumer product manufacturers. She also regularly advises on administrative litigation and government enforcement matters involving FDA-regulated companies.
Kellie is ranked as a leading lawyer in the pharmaceutical and medical products space by Chambers USA, where she maintains a Band 1 ranking. Clients describe her as “incredibly responsive, measured and thoughtful” and note that she is “personable, responsible, reliable, and honest.” Kellie takes a practical, solutions-oriented approach to counseling clients and has wide-ranging experience advising legal and business leaders at the world’s leading life sciences companies, in addition to early-stage companies. She also maintains an active pro bono practice, is a member of the firm’s Pro Bono Committee, and is a hiring partner at the firm.
Experience
Advertising and Promotion
- Represented Pacira Pharmaceuticals, Inc. in its litigation against and subsequent settlement with FDA, which resulted in the withdrawal of an FDA Warning Letter alleging that the company had promoted its drug off-label (No. 15-7055, S.D.N.Y. Sept. 8, 2015)
- Serve as co-counsel to the Medical Information Working Group, an informal coalition of 10 medical product manufacturers seeking changes to the FDA rules governing the communication of truthful, non-misleading information that does not appear in product labeling
- Develop policies, procedures, and training materials governing the review, approval, and use of promotional and non-promotional materials
- Counsel biopharmaceutical and medical device companies on a wide variety of product communications issues, including off-label communications, social media promotion, and virtual scientific exchange
- Represent life sciences manufacturers in competitive disputes involving false or misleading product communications
- Led multiple compliance assessments of sales and medical organizations at biopharmaceutical and medical device companies, which involved conducting interviews with target personnel, reviewing policies and procedures, evaluating promotional and non-promotional materials and practices, and providing recommendations for enhanced risk management
Digital Health
- Advise clients on development, FDA regulatory classification, and commercialization of digital health tools, including clinical decision support software, mobile medical apps, general wellness devices, and products that incorporate artificial intelligence, machine learning, and other cutting-edge technology
- Counsel clients on the generation and use of real-world evidence in FDA regulatory submissions
- Collaborate with cross-practice colleagues to develop terms and conditions and privacy policies for digital health products
- Drafted comments for pharmaceutical and medical device companies regarding FDA’s proposed framework for regulation of prescription-drug-use-related software
- Counsel providers and academic medical centers on the research and clinical use of medical device software invented and developed in-house
Other Regulatory
- Advise biopharmaceutical manufacturers during the product development process and in labeling negotiations with FDA
- Counsel companies on drug and biologic exclusivity
- Advise biopharmaceutical manufacturers in connection with REMS modifications and safety labeling updates
- Assist clients seeking expedited development and approval incentives
- Counsel companies on clinical trial transparency initiatives, including compliance with laws and the communication of results to clinical trial subjects
Transactional Work
- Represent life sciences companies, private equity funds, and financial institutions in transactions with drug, biologic, device, cosmetic, and consumer products manufacturers, including license and collaboration agreements, public and private securities offerings, and mergers and acquisitions
- Lead regulatory due diligence teams in US and global transactions
- Conduct post-closing assessments of regulatory compliance