Off-Label Communication: Top Tips for Compliance

Keynote Speaker

Ethan DavisEthan Davis

Ethan P. Davis is the Deputy Assistant Attorney General for the Consumer Protection Branch at the Department of Justice. In that role, he oversees the Branch’s efforts to enforce the Food, Drug, and Cosmetic Act throughout the United States. Before joining the Justice Department, Ethan was a partner at King & Spalding LLP, where his practice spanned a wide range of civil and criminal life sciences and health care matters. Ethan has argued in many federal and state courts around the country, including the U.S. Supreme Court. Earlier in his career, Ethan was a trial attorney in the Justice Department’s Civil Division and, before that, a law clerk to Judge Diarmuid F. O’Scannlain of the Ninth Circuit. He is a graduate of Yale Law School and Amherst College.


Nikki ReevesNikki Reeves Esq.

Nikki Reeves Esq., partner, King & Spalding, claims 18+ years counseling pharma and device companies on pre- and post-market FDA regulatory compliance and enforcement. Clinical trials, GMP, labeling, advertising and promotion all fall under her bailiwick, as well as federal “sunshine” state and international transparency/disclosure laws. A frequent speaker and author on FDA advertising/promotion and transparency law, she serves currently on the FDAnews Advisory Committee and formerly on the Editorial Advisory Board of the FDLI Food & Drug Law Journal.



Katlin BackfieldKatlin Backfield, Attorney and Consultant, Backfield, PLLC; former Associate Chief Counsel for Drugs, FDA

With over 15 years of experience in the area of pharmaceutical regulatory law, including more than 10 years at the Food and Drug Administration, Katlin uses her extensive expertise to help companies navigate the pre- and post-approval stages of drug development. Katlin served as Associate Chief Counsel for Drugs with the Office of Chief Counsel at FDA for nine years. She was a regulatory counsel in the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research at FDA from 2006 to 2008. Prior to joining FDA, Katlin was an associate at Hogan Lovells, LLP, and a law clerk for the Honorable Douglas P. Woodlock of the U.S. District Court for the District of Massachusetts. She graduated cum laude from Georgetown University Law Center in 2001 and received her undergraduate degree from Davidson College. Katlin serves on the planning committee for the Food and Drug Law Institute's Advertising and Promotion Conference to be held in September 2017 and is a member of FDLI's Academic Programs Committee. She is based in Washington, D.C.


Heather BañuelosHeather Bañuelos, Counsel, King & Spalding LLP

Heather Bañuelos is a member of the FDA and Life Sciences practice in Washington, D.C. Her practice focuses on the regulation of prescription and nonprescription drugs, food, cosmetics, and dietary supplements. She advises clients on a wide range of regulatory, compliance and enforcement issues regulated by the Food and Drug Administration, as well as other related federal and state agencies, such as the Department of Agriculture and Federal Trade Commission. She has significant experience advising on regulatory strategies and initiatives for the development, labeling, promotion and advertising of FDA-regulated products.


David BlochDavid Bloch, Principal Legal Counsel, Medtronic

David Bloch is Principal Legal Counsel at Medtronic, PLC. At Medtronic and in private practice before that, he has spent more than 20 years counseling clients in the healthcare industry on compliance with government regulation, including requirements of the Food and Drug Administration, anti-kickback standards and HIPAA privacy. He has been active in industry groups on data privacy, including serving as chair of the Medical Device Privacy Consortium in 2014, leading their efforts to address privacy and cybersecurity issues for the device industry, including drafting position papers, recommending standards and coordinating advocacy efforts. He is a graduate of Columbia College and University of Pennsylvania Law School.


Jeffrey S. BucholtzJeffrey S. Bucholtz, Partner, King & Spalding LLP

Jeff Bucholtz focuses on appeals and legal issues before federal and state courts across the country. As a partner in our Appellate, Constitutional and Administrative Law and Contracts and Business Torts practices, Jeff represents clients in a wide range of civil, regulatory and criminal matters.



Don BunninDon Bunnin, Executive Director, Senior Counsel - Litigation & Commercial Eye Care, Allergan

Don is head legal counsel to Allergan’s eye care, psychiatry, women’s health, and internal medicine franchises. He provides counsel to executive management, product marketing, research & development, sales operations, managed markets, and corporate and public communications. He advises on FDA regulations, federal and state anti-kickback statutes, fraud and consumer protection, intellectual property, and contractual issues. He assists in training of business units and sales representatives and is a member of advertising and promotional review steering committees. Don is also responsible for all facets of Allergan’s commercial litigation. He litigates antitrust, securities, intellectual property, product liability, and employment matters. He is responsible for federal and state government investigations and enforcement actions and qui tam litigation under federal and state False Claims Acts.


Carolyn BrugueraCarolyn Bruguera, Vice President and General Counsel, MDMA

Carolyn Bruguera is Vice President & General Counsel for the MDMA. She brings extensive experience in the management of legal affairs and compliance for medical device manufacturers. Prior to joining MDMA, Carolyn served as Vice President of Consulting Services for R-Squared Services & Solutions, Inc. (acquired by IMS Health) where she advised dozens of clients in domestic and foreign antikickback and anticorruption compliance, data privacy, Open Payments and international transparency requirements. She also served as Vice President and General Counsel to Hansen Medical, Inc., a California-based manufacturer of robotics for intravascular procedures, and to Micrus Endovascular Corporation, from its initial public offering through its acquisition by Johnson & Johnson. Before joining the medical device industry, Carolyn was a corporate and securities attorney in private practice. She received her JD from the University of California, Berkeley’s Boalt Hall School of Law, and her AB, magna cum laude, from Harvard University. She speaks French fluently and is a member of the California bar.


Lisa M. DwyerLisa M. Dwyer, Partner, King & Spalding LLP

Lisa Dwyer specializes in legal and policy matters relating to drugs and devices. A partner in our FDA and Life Sciences practice, Lisa strategizes with leading companies on regulatory, litigation and policy matters to achieve business objectives.



Joshua EizenJoshua Eizen, U.S. Chief Compliance Officer, Actellion






Sean FlynnSean Flynn, Associate General Counsel and Chief Compliance Officer, ABIOMED, Inc.

Sean Flynn currently serves as Associate General Counsel and Chief Compliance Officer for Abiomed, Inc. In that capacity, Sean is responsible for business and legal matters touching every corner of the publicly-traded Massachusetts medical device company, which specializes in providing products designed to assist the human heart and circulatory system. As Chief Compliance Officer, Sean is responsible to the compliance readiness of the company on a global scale. Prior to joining Abiomed, Sean served for seven years as a federal prosecutor with both the United States Attorney’s Offices for the Eastern District of California and the Eastern District of New York. As an Assistant United States Attorney, Sean was lead investigator and prosecutor on a wide assortment of fraud and corruption-related matters, and held a variety of supervisory positions, to include Health Care Fraud Coordinator. Sean began his legal career as a litigator with Bingham McCutchen LLP, after clerking for the Honorable Ruggero J. Aldisert, Senior Circuit Judge, United States Court of Appeals for the Third Circuit.

Prior to beginning his legal career, Sean served as an air defense artillery officer for the United States Army, having graduated from the United States Military Academy at West Point in 1995.


Kelly GoldbergKelly Goldberg, Vice President, Law & Senior Counsel for Biopharmaceutical Regulation, PhRMA

Kelly Goldberg is Vice President, Law/Senior Counsel for Biopharmaceutical Regulation at PhRMA. Ms. Goldberg joined PhRMA in April 2017. In her role, Ms. Goldberg has responsibility for all FDA and related regulatory law issues.

Prior to joining PhRMA, Ms. Goldberg spent over a decade at Pfizer, where most recently she was Senior Corporate Counsel in Pfizer’s Regulatory Law group. In that role, Ms. Goldberg previously chaired PhRMA’s FDA Regulatory Focus Group. Ms. Goldberg was also responsible for counseling internal clients on a wide-range of regulatory issues, including data exclusivity, biosimilars, orphan drug provisions, drug safety and risk evaluation and mitigation strategies, drug labeling, drug approval standards and pathways, and advertising and promotion.

Ms. Goldberg was an associate in the Food and Drug practice group at Covington & Burling before joining Pfizer. She earned her J.D., cum laude, from the University of Pennsylvania Law School and clerked for the Honorable Joseph E. Irenas on the United States District Court for the District of New Jersey. Ms. Goldberg received her Bachelor of Arts in History from the University of Virginia.


Pete LeiningerPete Leininger, Counsel, King & Spalding LLP; former Associate Chief Counsel for Enforcement at FDA

Pete Leininger is an attorney in King & Spalding’s FDA and Life Sciences Practice. From 2012 until May of this year, Pete served as an Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel. During his time at FDA, Pete specialized in criminal enforcement and worked on several international investigations involving supply chain security and drug manufacturing problems in India and China.


John MurphyJohn Murphy, Deputy General Counsel, BIO

John Murphy serves as the Deputy General Counsel at the Biotechnology Innovation Organization (BIO). BIO is the largest trade association in the world representing biotechnology companies. BIO members are involved in the research and development of innovative healthcare, agricultural, and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.

Mr. Murphy’s role encompasses all legal issues impacting healthcare biotechnology across the Country. His responsibilities include issues in Congressional legislation, FDA, CMS and various other federal agency regulatory issues, litigation, and support on state-developed biotechnology laws and regulations. Mr. Murphy is a frequent speaker on issues associated with patient access to prescription medicines, prescription drug abuse, drug pricing, and more general issues impacting medicine approvals and innovation in the United States.

Mr. Murphy is a graduate of Villanova University and the Catholic University Columbus School of Law. He worked on healthcare regulatory and enforcement issues at Hogan Lovells, LLP, and served as Assistant General Counsel for the Pharmaceutical Research and Manufacturers of America before joining BIO.


Gillian M. RussellGillian M. Russell, Counsel, King & Spalding LLP

Gillian Russell is counsel in the firm’s FDA and Life Sciences practice. Gillian advises pharmaceutical, biotechnology and medical device companies on a variety of U.S. Food and Drug Administration (FDA) and healthcare regulatory compliance matters, including product advertising and promotion, federal healthcare compliance programs, clinical trial regulation, and FDA enforcement actions. In addition, Gillian regularly counsels clients in the cosmetics industry and has advised clients in the food industry. Gillian’s practice also focuses on regulatory requirements imposed by the U.S. Drug Enforcement Administration (DEA), the Federal Trade Commission (FTC) and state boards of pharmacy.


John RichterJohn Richter, Partner, King & Spalding LLP

John Richter is a litigation partner in the Special Matters and Investigations Practice Group, and works with companies, Boards of Directors, Board committees, and individuals facing a variety of white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. The group has been twice recognized by Law360 as “White-Collar Group of the Year” and described as “the premier firm in this practice area” by the U.S. News & World Report/Best Lawyers’ “Best Law Firms” survey.

Law360 named John "White-Collar MVP of the Year" in 2016. In 2017, he was recognized as one of the top 100 trial lawyers in America by Benchmark Litigation and as a Life Sciences Star for litigation by LMG Life Sciences.


Paul SavidgePaul Savidge, General Counsel, Spark Therapeutic

Paul Savidge is senior regulatory counsel at Spark Therapeutics, a leading gene therapy company, where he provides counsel on a broad range of issues, including those related to drug development and commercialization. Prior to joining Spark, Paul was senior vice president and deputy general counsel at Bristol-Myers Squibb and led the legal groups assigned to the company’s global commercial and research organizations. Prior to BMS, Paul held positions in the U.S. and European legal departments at Merck. Paul received his JD from Washington & Lee University, an MBA from the Kellogg School of Management at Northwestern University and a BSFS from Georgetown University’s School of Foreign Service.