Kellie B. Combs

Partner

Kellie B. Combs

Partner

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Kellie Combs 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 is a partner in the life sciences regulatory and compliance group and is also a co-chair of the firm’s cross-practice digital health group. Kellie has extensive experience handling matters implicating FDA promotional rules and the First Amendment and also advises clients on FDA regulatory submissions, 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. 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.

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

Publications

  • The Best Lawyers in America (2022)
  • Lifestars “European Deal of the Year Under £500 Million” (2019)
  • Chambers USA: America’s Leading Lawyers for Business (2017-2021)
  • Washington, D.C. Super Lawyers Rising Star (2014-2019)

Presentations

Publications

FDA Regulatory Alerts

  • Click here to read our recent FDA Regulatory Alerts.

Presentations

  • Presenter, “Communicating Directly with Consumers on Social Media: What You Must Know About FDA and FTC Ad and Promo Rules” FDAnews Webinar (April 28, 2022)
  • Moderator, “Digital Health Dealmaking by Biopharma and Tech: An Innovation Match Made in Heaven?” HLTH Digital (March 1, 2022)
  • Speaker, “Outlook 2022: Washington, DC Updates and Insights on Life Sciences,” Ropes & Gray Webinar (February 10, 2022)
  • Speaker, “FDA Under a Biden Administration: What Has Happened So Far, and What Can We Expect?” American Health Law Association (November 30, 2021)
  • Moderator, “Best Practices for Globalizing Promotional Review,” Advertising and Promotion for Medical Products Conference, Food and Drug Law Institute (October 29, 2021)
  • Speaker, “Assessing the Recent Explosion of Digital Health and Health Tech: An Industry Discussion of the Latest Deals, Increasing Regulations and the Top Legal Issues to Have on Your Radar,” ACI Women Leaders in Life Sciences Law (July 28, 2021)  
  • Speaker, “Outlook 2021: Washington, D.C. Updates and Insights on Life Sciences and Health Care,” Ropes & Gray Teleconference (February 25, 2021)
  • Speaker, “Hot Topics in Pre-Approval Communications,” Advertising and Promotion for Medical Products Conference, Food and Drug Law Institute (October 29, 2020)
  • Speaker, “Life Sciences Regulatory Update: US, Europe and China,” Ropes & Gray Third Annual International IP Summit (October 20, 2020)
  • Speaker, “Regulation of Digital Health During and After COVID-19,” Digital Health Technology and Regulation During COVID-19 and Beyond conference, Food and Drug Law Institute (September 10, 2020)
  • Speaker, “Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA,” Food and Drug Law Institute (September 9, 2020)
  • Speaker, “Navigating Digital Health Investments and the Dealmaking Landscape,” Ropes & Gray Webinar (September 2, 2020)
  • Speaker, “Scientific Exchange: Grey Areas and Best Practices,” Advertising and Promotion for Medical Products Conference, Food and Drug Law Institute (October 18, 2019)
  • Speaker, “SEC Enforcement and Class Actions Regarding FDA Communications,” Ropes & Gray’s Q3 Life Sciences Quarterly Seminar (September 12, 2019)
  • Speaker, “Expedited FDA Programs for Drugs, Biologics, Devices, and Combination Products,” FDANews Webinar (July 30, 2019)
  • Speaker, “A State of the Union on Key Legal Developments Impacting the Life Sciences Industry in the Last Year,” Women Leaders in Life Sciences Law Conference (July 25, 2019)
  • Speaker, “Advertising and Promotion Regulatory Affairs Conference,” DIA Global (March 1, 2019)
  • Speaker, “The Fine Line of Promotion with Medical Professionals: Avoiding White Coat Marketing,” Pharmaceutical and Medical Device Compliance Congress (November 8, 2018)
  • Moderator, “Real-World Evidence and Real-World Data: Practices for Promotional Use and Avoiding False and Misleading Communications,” Advertising & Promotion for Medical Products Conference, Food and Drug Law Institute (October 16, 2018)
  • Speaker, “Digital Health: Staying Ahead of the Future of Life Sciences” at the American Conference Institute’s Women Leaders in Life Sciences Law in Boston (July 27, 2018)
  • Speaker, “The FDA in the Gottlieb Era,” Coalition for Healthcare Communication’s Rising Leaders Conference (May 23, 2018) 
  • Speaker, “Introduction to FDA Review and Approval of Biological Products,” Food and Drug Law Institute (March 20, 2018)
  • Speaker, “Outlook 2018 Teleconference: The Trump Administration’s Impact on Life Sciences and Health Care—the First Year,” Ropes & Gray Teleconference (January 23, 2018)
  • Speaker, “1st Amendment Considerations and Off Label Communications,” Advanced Medical Technology Association’s 8th Annual Advertising and Promotion of Medical Devices Conference (November 15, 2017)
  • Moderator, “Scientific Exchange and the First Amendment,” FDLI Advertising and Promotion Conference (September 2017)
  • Panelist, “Off-Label Communications to Health Care Professionals and Consumers,” Drug Industry Association Annual Meeting (June 2017)
  • Panelist, “Effective Life Cycle Management: From Lab to Launch: Optimizing Intellectual Property Rights in Life Cycle Management Strategy,” Drug Industry Association Annual Meeting (June 2017)
  • Speaker, “Revisiting the Trump Administration’s Impact on Life Sciences and Health Care — the First 100 Days,” Ropes & Gray Teleconference (May 2017)
  • Speaker, “Recent FDA Guidance Documents on Manufacturer Communications about Medical Products,” Food and Drug Law Institute Webinar (March 2017) 
  • Speaker, “Outlook 2017: The New Administration and Its Impact on Life Sciences and Health Care,” Ropes & Gray Teleconference (January 2017)
  • Panelist, “Truthful and Non-Misleading Communications and Recent First Amendment Cases,” Pharmaceutical and Medical Device Compliance Congress (October 2016)
  • Moderator, “FDA Guidances: An Industry Perspective,” Food and Drug Law Institute Advertising and Promotion Conference (September 2016)
  • Panelist, “Marketing After Amarin and Pacira,” Drug Industry Association Annual Meeting (June 2016)
  • Panelist, “First Amendment and Off-Label Promotion: The Post-Amarin Landscape,” FDA/CMS Summit (December 2015)
  • Moderator, “Joint Ventures and Co-Promotion Arrangements,” Pharmaceutical Compliance Congress and Best Practices Forum (October 2015)
  • Presenter, “Understanding & Complying With Clinical Trial Registration and Results Requirements,” Clinical Research Transparency & Data Disclosure Strategies Conference (July 2015)
  • Presenter, “FDA Guidance on Social Media and the Impact on Medical Communications,” Medical Communications & Dissemination of Healthcare Information Conference (February 2015)
  • Panelist, “The Regulatory Process: A Conversation About Getting To, and Through, the FDA Approval Process, and How Patient Voices Can Help,” MassBio Conference on Building a Patient-Centered Biotech (November 10, 2014)
  • Co-Presenter with Joy Liu, “Recent Draft Guidance on Social Media: Implications for Drug and Device Marketing in the Digital Age,” Webinar (July 22, 2014)
  • Presenter, “Considerations When Leveraging Digital and Mobile Networks to Increase Consumer Interaction,” Pharmaceutical & Medical Device Legal & Compliance Forum (March 26, 2014)
  • Panelist, “Communicating During the Pre-Approval Stages,” Drug Industry Association’s Marketing Pharmaceutical Conference (February 28, 2014)
  • Co-Presenter with Joy Liu, “FDA Update: Social Media Use By Life Science Companies,” All Hands Meeting (December 5, 2013)
  • Presenter, “A View from the Drug Side," AdvaMed’s Advertising and Promotion Workshop, (November 14, 2013)
  • Presenter, “Overview of Medical Device Companies’ Social Media Practices,” Medical Device Summit: Digital Advertising & Social Media in the Medical Device and Diagnostics Industries (October 23, 2013)
  • Co-Presenter with Mark Barnes, “Public Access to Clinical Trials Data: Draft European Medicines Agency (EMA) Policy,” issued June 24, 2013, and “FDA Request for Comments,” issued June 4, 2013, Teleconference (July 11, 2013)
  • Co-Presenter with Mark Barnes, “Proposed European Medicines Agency Policy on Mandatory Sharing of Participant-Level Clinical Trials Data: What it Means for the Future Planning and Conduct of Clinical Research,” Teleconference (April 10, 2013)
  • Panelist, “Working Together Within the Guidelines: Interactive Case Studies,” 22nd Annual Conference of the National Task Force on CME Provider/Industry Collaboration (October 12, 2012)
  • Co-Presenter with Joy Liu, “Using Social Media Outlets for Drug Promotion,” Webinar (January 25, 2011)
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