Kellie B. Combs

Partner

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  • JD, Vanderbilt University Law School, 2005; Order of the Coif; Editor-in-Chief, Vanderbilt Law Review
  • BA (Public Administration), summa cum laude, Missouri State University, 2001; Honors College

Qualifications

  • District of Columbia, 2007
  • Arkansas, 2005

Court Admissions

  • U.S. Court of Appeals for the Sixth Circuit, 2005
  • Honorable Ronald L. Gilman, U.S. Court of Appeals for the Sixth Circuit
  • Editorial Advisory Board Member, Food and Drug Law Journal
  • Member, Food and Drug Law Institute’s Finance Committee
  • Chambers USA: America’s Leading Lawyers for Business (2017)
  • Washington, D.C. Super Lawyers (2014-2016)

Kellie B. Combs

Partner

Kellie Combs provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food, and cosmetic manufacturers on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. Recognized as a “Rising Star” in Food and Drug Law by Super Lawyers, Kellie has extensive experience handling matters implicating FDA promotional rules and the First Amendment and also routinely advises clients on lifecycle management, regulation of clinical research, and post-approval compliance. In addition, Kellie conducts regulatory due diligence in connection with transactions involving drug, device, dietary supplement, cosmetic, and other consumer product manufacturers, and she has advised on a number of government investigations of FDA-regulated 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)
  • Routinely advise major pharmaceutical and biotechnology companies regarding communication of health care economic information and comparative effectiveness information to payers 
  • Developed a pharmaceutical company’s “Core Claims Manual,” which described FDA promotional rules in detail and outlined which concepts, data sources, graphics, and claims were appropriate for use in product promotion
  • Conducted an assessment of a pharmaceutical company’s promotional review committee, which involved interviewing a dozen high-level employees, reviewing SOPs and other internal guidance documents, evaluating a sampling of promotional materials used by the company, and providing recommendations for enhanced risk management
  • Drafted a letter to FDA’s Office of Chief Counsel that resulted in the agency’s agreement that a pharmaceutical company could promote and disseminate clinical practice guidelines containing off-label information
  • Serve as co-counsel to the Medical Information Working Group, an informal coalition of 13 medical product manufacturers seeking changes to the FDA rules governing the communication of truthful, non-misleading information that does not appear in product labeling
  • Led an in-depth compliance assessment of a major pharmaceutical company’s field medical organization, which involved interviews of Medical Affairs personnel, review of medical information materials, analysis of field medical personnel’s email communications, and recommendations to mitigate identified risks 

Social Media

  • Routinely counsel pharmaceutical and medical device companies on the use of Twitter and Facebook in branded and unbranded communications
  • Advised a pharmaceutical company on the use of video-chat and other emerging social media technologies in product promotion and field medical communications 
  • Developed guidelines for a pharmaceutical company to follow as it added “chat boxes” to its website
  • Advised two medical device companies on the development and use of restricted-access electronic message boards for health care professionals
  • Assisted a major pharmaceutical company in the development of a medical information website to provide non-promotional product and disease-state information to prescribers 

General Regulatory

  • Advised a pharmaceutical manufacturer in connection with REMS modifications and safety labeling updates
  • Conducted a comprehensive audit of a major pharmaceutical company’s manufacturing policies and procedures to assess compliance with applicable laws, regulations, guidance documents, and industry standards
  • Counseled an academic medical center on the research and clinical use of medical device software invented and developed in-house
  • Drafted comments for a major pharmaceutical company regarding an FDA proposed rule that would permit generic drug manufacturers to unilaterally update the safety information in their product labeling 

Lifecycle Management

  • Counsel several clients on legal and policy issues associated with the development and approval of biosimilars
  • Drafted a citizen petition for a leading pharmaceutical company concerning bioequivalence and sameness issues associated with a complex oral product, which contained recommendations ultimately adopted by FDA
  • Counseled a pharmaceutical client on regulatory issues associated with switching a product from prescription to over-the-counter status
  • Provided legal and strategic advice to a pharmaceutical manufacturer developing a new product formulation
  • Advised several clients on issues related to orphan, pediatric, and biosimilars exclusivity

Regulation of Clinical Research

  • Assisted a major pharmaceutical company in responding to an FDA Warning Letter alleging violations of Good Clinical Practice regulations
  • Developed internal policies for a leading pharmaceutical company to govern the registration of clinical trials and reporting of results
  • Counseled a pharmaceutical client on the reporting of adverse events in clinical trials
  • Developed policies to govern and drafted agreements for use in a pharmaceutical company’s Investigator-Initiated Research program
  • Advised a multinational pharmaceutical company in its initiative to increase transparency of clinical trial results

Transactional Work

  • Advised on a wide variety of transactions involving FDA and FTC regulatory issues, including mergers and acquisitions, license and collaboration agreements, and public and private securities offerings.
  • Represented a number of private equity funds and financial institutions involved in transactions with drug, device, dietary supplement, and cosmetic manufacturers.
  • Routinely conduct due diligence on FDA-regulated companies.

Publications

FDA Regulatory Alerts

  • Click here to read our recent FDA Regulatory Alerts.

Presentations

  • 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)