Kellie B. Combs

Publications

• Co-author, “Pharmaceutical Advertising Laws and Regulations: A Global Comparative Analysis on Advertising and Promotional Rules 2023,” International Comparative Legal Guide (July 13, 2023)
• Co-author, “A Global Comparative Analysis on Advertising and Promotional Rules,” International Comparative Legal Guides: Pharmaceutical Advertising Laws and Regulations 2023 (July 14, 2023)
• Contributor, “The Global Landscape of Digital Health,” International Comparative Legal Guides: Digital Health Laws and Regulations 2023 (March 17, 2023)
• Co-author, “Artificial Intelligence in Life Sciences,” Intellectual Property & Technology Law Journal (October 28, 2022)
• Co-author, “A Cross-Border Regulatory and Public Policy Analysis of Machine Learning and Artificial Intelligence: The Future of AI in Life Sciences,” Intellectual Property & Technology Law Journal (November-December 2022)
• Co-author, “Global Trends in Regulatory Compliance Challenges in Advertising and Promotion” International Comparative Legal Guides Pharmaceutical Advertising Laws and Regulations 2022  
• Co-author, “Global Landscape of Digital Health: Impact on Healthcare Delivery and Corresponding Regulatory and Legal Considerations,” International Comparative Legal Guide chapter (February 24, 2022)
• Quoted, “'Voracious Consumers of Capital': How the Life Sciences Boom Is Fueling Law Firm Business,” The American Lawyer, Law.com, The Recorder (September 7, 2021)
• Profiled, “Law360's 2021 Life Sciences Editorial Board,” Law360 (April 12, 2021)  
• Co-author, “Digital Health 2021: Trends in Big Data, AI, Telehealth, and Beyond,” Bloomberg Law (January 4, 2021)
• Co-author, “2 Major Digital Health Trends Driven By COVID-19,” Law360 (December 22, 2020)
• Quoted, “Digital therapeutic makers see opportunity as pandemic prompts FDA to ease rules,” MedTech Dive (April 24, 2020)
• Quoted, “Transition Day In The US: 96 Drugs Make The Move To Biologics Regulation” Pink Sheet (March 23, 2020)  
• Co-author, “FDA-FTC Biosimilar Push Clarifies Antitrust Stance,” Law360 (February 19, 2020) 
• Quoted, “Pre-approval Promotion: Corporate Communications May Draw US FDA Scrutiny,” The Pink Sheet (March 25, 2019)
• Co-author, “Proposed FDA Drug Software Rules Strict On Pharma Companies,” Law360 (December 10, 2018)
• Co-author, “A Closer Look At CMS' Drug Price Disclosure Proposal,” Law360 (October 24, 2018)
• Co-author, “FDA Clarifies Communication Rules for Medical Product Cos.,” Law360 (June 21, 2018)
• Quoted, “FDA guidelines for payer, off-label communications: OK as long as 'truthful',” Medical Marketing & Media (June 14, 2018)
• Quoted, “FDA Widens Scope Of Guidance On Communication To Payers,” Inside Health Policy (June 13, 2018)
• Quoted, “4As O'Brien: How healthcare marketing has changed under Trump,” Medical Marketing & Media (May 23, 2018)
• Quoted, “FDA Ad and Promo Enforcement Targets Presentation of Risk Info, Pre-Approval Promotions,” Drug Industry Daily (May 1, 2018)
• Cited, “FDA's Off-Label Delay Not Enough For Big Drugmakers,” Law360 (February 7, 2018) 
• Quoted, “'Low-Hanging Fruit' Of Industry Comms Policy Addressed By Recent FDA Documents,” Medtech Insight (March 22, 2017)
• Quoted, “Biopharma Wins Reprieve on U.S. FDA ‘Intended Use’ Rule,” The Pink Sheet (March 18, 2017)
• Quoted, “Drug, Device Industries Get One-Year Delay on Off-Label Rule,” Bloomberg BNA’s Health Care Daily Report (March 17, 2017)
• Quoted, “FDA Revisits Rules on Drug and Device Communication,” Pharmacy & Therapeutics (March 1, 2017)
• Cited, “Big Pharma Challenges FDA’s New Off-Label Rule,” Law360 (February 9, 2017)
• Quoted, “FDA Guidance Seeks to Clarify Pharma Comms with Payers,” Medical Marketing & Media (January 24, 2017)
• Quoted, “Industry Communications with Payors: US FDA Okays Info on Investigational Drugs,” Pink Sheet (January 19, 2017)
• Quoted, “Off-Label,” Medical Marketing & Media (December 2016)
• Quoted, “Drugmakers to FDA: Let Us Share Off-Label Study Data with Payers,” FiercePharma (November 16, 2016)
• Quoted, “5 Takeaways From FDA’s Off-Label Promo Forum,” Law360 (November 9, 2016)
• Quoted, “Will drugmakers get what they're looking for at this week's FDA off-label hearing?” Medical & Marketing Media (November 7, 2016)
• Co-author, “In Pursuit of Evidence-Based Coverage: Navigating the FDA Regulatory Scheme in Communications with Payers,” Food and Drug Law Institute Update (September/October 2016) (Reprinted with permission from FDLI)
• Quoted, “Drugmaker Sues F.D.A. Over Right to Discuss Off-Label Uses,” New York Times (May 7, 2015)
• Co-author, “EMA Draft Policy on Publication and Access to Clinical Trials Data Provides Broad Researcher Access to Participant-Level Data,”Bloomberg BNA Life Sciences Law & Industry Report (July 17, 2013)
• Co-author, “Social Media and Prescription Drug Promotion: A Survey of Seven Companies’ Practices,” Bloomberg BNA’s Social Media Law & Policy Report (April 30, 2013)
• Co-author, “Drug Promotion in the Post-Caronia World,” Food and Drug Law Institute’s (FDLI) Update magazine (March/April 2013)
• “FDA Social Media Warning Letter: a Fragmented Approach to a Comprehensive Problem,” Legal Opinion Letter, Washington Legal Foundation (October 29, 2010)

FDA Regulatory Alerts

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Presentations

• Speaker, "The False Claims Act: Clinical Decision Tools," Ropes & Gray Webinar (September 12, 2023)
• Presenter, “Moving the Needle on Clinical Trial Diversity and Navigating New FDA Requirements for Diversity Action Plans,” American Conference Institute’s Women Leaders in Life Sciences Law (July 26, 2023)
• Speaker, “Compliance Considerations & Best Practices For Social Media-based Medical Communications,” Life Science Medical Communications Conference (January 30, 2023)
• Presenter, “Pharmaceutical Expedited Pathways,” FDANews Webinar (January 26, 2023)
• Moderator, “Regulatory and Enforcement Trends and Challenges in Digital Health,” FDLI Current Developments in Digital Health Technology and Regulation Conference (December 1, 2022)
• Speaker, “Marketing Ambiguities Surrounding Pre-Approval Promotion,” FDLI Advertising and Promotion Conference (October 13, 2022)
• Moderator, “Looking Back and Moving Forward: Analyzing Legal, Administrative, and Policy Developments Impacting the Life Sciences Industry and Influencing Your Career,” ACI Women in Life Sciences Law Conference (July 27, 2022)
• 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)