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Life Sciences 2021: Navigating Legal Challenges in Drug and Device Industries

Speaker(s): Adem Koyuncu, Charlene Keller Fullmer, Geoffrey R. Kaiser, Hillary Kalay, Howard Sklamberg, Jacob T Elberg, Kelly Cleary, Laura F. Laemmle-Weidenfeld, Nathan A. Brown, Robin Blaney, Scott D. Danzis, T. Reed Stephens, Uta Rawson, William Chang
Recorded on: Oct. 5, 2021
PLI Program #: 305925

Kelly M. Cleary represents clients on a diverse range of health care regulatory and policy matters, helping clients understand and navigate an increasingly complex and often changing regulatory code. As an advisor to health industry participants, she supports in-house legal and business teams in structuring complex transactions and other strategic initiatives in a manner that minimizes regulatory risk. She has particular experience in matters involving state and federal fraud and abuse laws, including the federal Stark Law and Anti-Kickback Statute and their state analogs, and the Patient Protection and Affordable Care Act (ACA) marketplace regulations. She also has successfully represented clients before administrative and judicial tribunals on matters relating to Medicare and Medicaid enrollment and reimbursement, as well as in lawsuits arising under the False Claims Act (FCA). In addition, Kelly advises clients on privacy, security and breach notification issues arising under state and federal laws.

Kelly rejoined Akin Gump after serving for three years at the Department of Health and Human Services (HHS) as Deputy General Counsel and Chief Legal Officer for the Centers for Medicare & Medicaid Services (CMS). While at HHS, she served as the principal legal counselor and advisor to the CMS Administrator and HHS leadership on all matters relating to the administration of federal health care programs covering more than 130 million Americans. At CMS, Kelly formulated legal strategy to advance policy priorities and optimize success in high-stakes litigation. She also served as a liaison with the Department of Justice (DOJ) on pending and anticipated litigation, with the Office of the Inspector General (OIG) on program integrity matters and with the White House on high-priority initiatives.

As CMS’s head lawyer, Kelly played a lead role in the Department’s efforts to revamp health care fraud and abuse laws, with a goal of creating more space for collaboration and innovation among health care providers.

Kelly was also the lead legal advisor to the Office of the National Coordinator for Health Information Technology (ONC) during development and implementation of policies to promote interoperability of electronic health records and curb “information blocking” practices that keep individuals from readily being able to obtain their electronic health records.

Kelly began her legal career as a law clerk for the Honorable Claude M. Hilton in the U.S. District Court for the Eastern District of Virginia. She served as editor-in-chief of the Catholic University Law Review.

Nathan A. Brown is a partner in the health care and life sciences practice who focuses on food and drug law, particularly as it relates to medical devices, drugs and biologics.

Practice & Background

Nathan A. Brown advises health industry participants with regard to medical devices, drugs and biologics, as well as cosmetics and food products regulated by the U.S. Food and Drug Administration (FDA). His practice covers regulatory, compliance and policy advice.

Prior to joining the firm, Mr. Brow n served in several prominent roles with the FDA. Most recently, he was detailed by the FDA to serve as health policy advisor to the Senate Health, Education, Labor and Pensions (HELP) Committee to cover FDA issues. On behalf of HELP Committee Chairman Tom Harkin (D-IA), Mr. Brow n played a lead role negotiating and drafting the Drug Quality and Security Act of 2013 (drug compounding and track and trace legislation), and coordinating passage of the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) reauthorizations. He advised committee leadership on a broad range of FDA-related legislative and oversight matters, including device, drug and biologics issues, and met with stakeholders across the FDA-regulated industries.

Before going to the Senate, Mr. Brown served in two roles at FDA. As special assistant to the chief counsel, he counseled FDA leadership on high priority and cross-cutting matters, including emerging public health issues, high-profile enforcement cases and congressional investigations. During his time in the Office of the Chief Counsel, he advised FDA’s Center for Devices and Radiological Health on a wide range of matters, including device review program reform, guidance development, software and health IT regulation, third-party review , laboratory developed tests and administrative appeals. He served as counsel on the medical device user fee reauthorization (MDUFA III) negotiation team, and represented FDA in providing assistance to Congress on device reform and MDUFA III provisions of the FDA Safety and Innovation Act of 2012 (FDASIA).

While at FDA, Mr. Brown also served as senior counselor to the associate commissioner for regulatory affairs (ACRA) in the Office of Regulatory Affairs (ORA), w here he advised the ACRA on compliance, enforcement and policy matters. He represented the ACRA in meetings with industry and in discussions with foreign governments regarding comparability and trade agreements. He also supervised priority matters for ORA, including implementation of FDASIA supply chain and enforcement provisions; coordination with the Office of the Chief Counsel on enforcement matters and litigation; organization of ORA efforts around import policy and implementation of the Food Safety and Modernization Act; and advising the ACRA on enforcement cases and appeals decisions.

Prior to his work at FDA, Mr. Brown was a lawyer in private practice, w here he focused on providing regulatory, legislative and litigation counsel to national associations, public and non-profit hospitals and other health care providers in a wide range of issues relating to Medicaid, Medicare and other health programs. He represented clients before the Centers for Medicare & Medicaid Services, the Department of Health and Human Services Departmental Appeals Board, various state agencies and in litigation in federal and state courts. He also advised clients on election law and lobbying law requirements. 

Public Service

Member, Montgomery County Board of Social Services (2008-2013)

Co-Chair, Maryland Health Benefit Exchange Advisory Committee on Financial Sustainability (2011-2012)

Steering Committee Member, Maryland Women’s Coalition for Health Reform(2006-2011)

Staff Member, Gov. O’Malley’s Transition Work Group/Maryland Department of Health and Mental Hygiene (2006-2007)

Community Involvement

In 2001, Mr. Brown served for six months at Bread for the City Legal Clinic, w here he handled a variety of Social Security disability appeal cases, family law matters and landlord and tenant cases.

Speaking Engagements

“What Hospitals Need to Know about the New Compounding Law ,” July 29, 2014.

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm's "Food, Drug & Device" practice group and also a member of our Compliance practice. Adem is recognized as a "leading lawyer for pharma and medical devices Law" (JUVE 2019).

He has a broad European life sciences practice and knows the healthcare sector also from his earlier work in the pharmaceutical industry and as a medical doctor. Clients praise his “understanding of complex regulatory issues, business acumen and industry experience” (Legal 500 2015). He helps clients on a wide range of EU and German law issues and also provides strategic advice. His broader practice also includes compliance, privacy and liability matters. He represents clients before courts and authorities and assists them in contract negotiations, internal investigations and transactions. For many years, Adem is listed in various rankings. He is described as "versatile and competent" (JUVE 2019), "incredibly fast" (JUVE 2018) and "very good and pleasant lawyer"(JUVE 2017) who provides advice at "an outstanding level" (Legal 500 2015).

Adem is the author of numerous publications and frequent speaker at different events.

Assistant United States Attorney Charlene Keller Fullmer is the Deputy Chief for Affirmative Litigation in the Civil Division of the United States Attorney’s Office in the Eastern District of Pennsylvania, where she supervises and prosecutes health care and affirmative fraud matters. She led the Philadelphia civil prosecution team that investigated and resolved allegations of off-label promotion of the atypical antipsychotic drug Risperdal by Johnson and Johnson and its subsidiary Janssen Pharmaceuticals, which resulted in a $2.2 billion global settlement with the Department of Justice, the largest paid for a single drug. In 2009, she served on the team that investigated and resolved allegations of off-label promotion and kickbacks by Pfizer, Inc. The $2.3 billion civil and criminal resolution was at the time the largest health care fraud settlement in the history of the Department of Justice. For her efforts in these matters, she was the recipient of the 2014 Attorney General’s Award for Fraud Prevention, an Award of Commendation from the Assistant Attorney General for the Civil Division, Tony West, and the 2014 National Health Care Anti-Fraud Association’s Investigation of the Year. In October 2010, Attorney General Eric Holder presented her with the Attorney General Award for Exceptional Service, the Department of Justice’s highest commendation.

Ms. Fullmer returned to the Justice Department in 2007 after six years in private practice at Duane Morris LLP in Philadelphia, where she litigated defensive matters, including False Claims Act, health care, white collar, antitrust, and insurance coverage litigation. Prior to that time, she served as an Attorney Advisor in Washington, DC and Quantico, VA with the Federal Bureau of Investigation, Office of Professional Responsibility, the Bureau’s Internal Affairs.

She is a 1993 graduate of Lehigh University, cum laude, and a 1996 graduate of Temple University School of Law, cum laude, where she served on the Law Review.

Geoffrey (Jeff) R. Kaiser, who has extensive experience in the healthcare industry, concentrates his legal practice on healthcare fraud and regulatory compliance issues, white collar criminal defense, False Claims Act litigation, integrity monitoring, and internal investigations. Jeff is the head of the Compliance, Investigations and White Collar Practice Group, and is a partner in the Health Services Practice Group. The Health Services Practice Group has been listed in the prestigious Legal 500. The practice is also recognized as “notable” by Chambers USA.

Before joining Rivkin Radler, Jeff served for nearly 10 years in the Criminal Divisions of the U.S. Attorney’s Office for the Eastern District of New York and the U.S. Attorney’s Office for the Southern District of New York. While at the Justice Department, he directed many white collar investigations and prosecutions, including with respect to healthcare fraud, securities fraud, mortgage fraud, mail and wire fraud, and bank fraud.

As Chief of Health Care Fraud Prosecutions and Deputy Chief of Public Integrity in the Eastern District U.S. Attorney’s Office, Jeff directed investigations of fraud allegations against individuals and corporations. He also exercised oversight responsibilities within the Public Integrity Section and overall healthcare fraud cases within the Eastern District of New York. He received many recognitions and honors for his efforts as a federal prosecutor.

After leaving the Justice Department, Jeff served as a managing director with Navigant Consulting, Inc., a global expert services firm, in two of its practice groups: Disputes and Investigations and Healthcare Disputes, Compliance and Investigations. While at Navigant, Jeff led teams performing internal investigations and integrity monitorships of individuals and organizations in the healthcare, construction, and transportation industries, and supervised a major forensic review of mortgage servicing practices by a national mortgage servicer.  He also oversaw the implementation of anti-counterfeiting/brand protection strategies on behalf of global brand owners.

Jeff worked as a civil litigator for more than a decade, handling commercial litigation matters involving an assortment of business disputes.  He developed particular experience in the investigation and prosecution of complex civil frauds under multiple common law and statutory grounds, including the federal Racketeer Influenced and Corrupt Organizations Act (RICO).  In addition, Jeff has acted as advisor to a global conglomerate in the area of anti-counterfeiting and brand protection.

Jeff received his B.A. with Honors from the University of Virginia, where he also graduated Phi Beta Kappa.  He earned a J.D. from New York University School of Law, where he served on the Moot Court Board and received the Advocacy Award.  After graduating from law school, Jeff served for two years as law clerk to the Hon. Fritz W. Alexander II, an associate judge on New York State’s highest court, the New York Court of Appeals.

A frequent writer and speaker on a range of legal topics, particularly in the areas of healthcare fraud and compliance, Jeff was named a Super Lawyer in the Metro New York area, 2012-2017.  Jeff is an adjunct professor of law at St. John’s University School of Law, where he teaches Health Care Fraud.

The Health Services practice has been included in the Chambers USA directory in the Healthcare category.

Howard Sklamberg counsels clients on a wide range of compliance and enforcement issues related to US Food and Drug Administration (FDA) regulation and policy. His experience is rooted in a deep understanding of US and foreign food, drug and medical devices law and policy, and is able to guide domestic and international clients through the regulatory challenges they face. Areas of expertise include inspections and warning letters, investigations, civil and criminal enforcement, medical product applications and clinical research, food and hemp regulation, imports, the development of FDA policy and FDA-related legislation, and business transactions involving FDA-regulated companies.

Prior to entering private practice, Mr. Sklamberg held a variety of roles at the FDA from 2010 to 2017, including Deputy Commissioner for Global Regulatory Operations and Policy; Director of the Office of Compliance, Center for Drug Evaluation and Research; Deputy Associate Commissioner for Regulatory Affairs; and Director in the Office of Enforcement. While at the agency, he directed an office of over 5,000 employees in more than 200 offices, laboratories and import facilities across the United States, Asia, Europe, and Latin America. As Deputy Commissioner, Mr. Sklamberg was FDA's top enforcement official. He oversaw the agency's inspections, enforcement, recalls, and import operations programs.

Mr. Sklamberg also led FDA's international program, including its agreements and cooperation with foreign regulators, harmonization initiatives, and oversight over the global supply chain. He also interacted with and testified before Congress on behalf of the agency, co-led FDA's implementation of the FDA Food Safety Modernization Act and was the lead official at FDA on a variety of issues including cannabis and hemp, counterfeit drugs, and FDA's Mutual Recognition Agreement with the European Union.

Earlier in his career, Mr. Sklamberg served as a prosecutor in the US Attorney's Office in Washington, DC, and in the Public Integrity Section of the Criminal Division at the Department of Justice.

Laura Weidenfeld is a partner in the Health Care and Life Sciences practice at Jones Day in Washington D.C.  Drawing on her extensive experience defending clients against health care fraud enforcement actions, Laura also provides practical compliance advice on Medicare and Medicaid fraud and abuse issues. She has defended against numerous investigations and litigation brought by the Department of Justice (DOJ), various U.S. Attorneys offices, the Department of Health and Human Services Office of Inspector General (HHS-OIG), state attorneys general, and other state and federal agencies. Laura also helps her clients navigate challenging compliance issues, including analyzing arrangements under the Stark Laws and Antikickback Statute, conducting internal investigations, and preparing self-disclosures.  Earlier in her career, Laura served as a trial attorney in the Frauds Section of the DOJ's Civil Division, where she conducted health care fraud investigations and litigation matters brought under the False Claims Act (FCA) and its whistleblower (or qui tam) provisions. 

Laura regularly speaks and writes on health care fraud and abuse issues and has been an active member of the American Health Law Association (Chair, Fraud and Abuse Practice Group, 2014-2017) for over 15 years. She is the author of Legal Issues in Health Care Fraud and Abuse, Fifth Edition, published by AHLA in 2020.  Laura received her JD from Georgetown University Law Center and her BA and BM from Northwestern University.

Professor Elberg teaches in the areas of Health Law, Health Care Fraud and Abuse, Evidence, and Data Analytics. His areas of interest include corporate crime and compliance, the role of various actors in the enforcement of health care fraud laws and regulations, and criminal justice policy. Professor Elberg also serves as a faculty advisor for Seton Hall’s Healthcare Compliance Certificate Programs around the world.

Prior to joining Seton Hall Law School, Professor Elberg served for 11 years as an Assistant U.S. Attorney at the U.S. Attorney’s Office for the District of New Jersey. As Chief of the Office’s Health Care & Government Fraud Unit for five years, Professor Elberg led one of the largest and most impactful health care units in the country, supervising a team of 15 AUSAs and directing all of the Office’s criminal and civil investigations and prosecutions of health care fraud offenses, including investigations and prosecutions of fraud against the government and private health insurance plans, illegal kickback schemes, violations of the Federal Food, Drug & Cosmetic Act, and the improper diversion of prescription drugs including opioids, as well as all health care-related actions brought by the Office under the False Claims Act. In addition, Professor Elberg supervised and directed investigations regarding Foreign Corrupt Practices Act violations, as well as fraud against certain other government agencies and programs. Professor Elberg launched the District of New Jersey’s Data Mining Working Group and spearheaded the Office’s efforts to utilize data analytics to identify, investigate, and prosecute health care fraud offenses.

In 2013, Professor Elberg was awarded the Department of Justice’s Executive Office of U.S. Attorneys Director’s Award for Superior Performance as an AUSA for his investigation and prosecution of Maxim Healthcare Services, et al., which resulted in a recovery of $150 Million (the largest ever in a home healthcare case), as well as the felony convictions of nine individuals in six states, including three senior executives of one of the nation’s largest home healthcare companies. In 2016, Professor Elberg led the prosecution of Olympus Corp., resulting in a $646 million global criminal and civil resolution for violations of the Anti-Kickback Statute and the Foreign Corrupt Practices Act – the largest total amount paid in U.S. history for violations involving the Anti-Kickback Statute and the largest resolution of any kind involving a medical device company. In 2018, Professor Elberg was awarded the Health & Human Services Office of Inspector General Award for Fighting Fraud, Waste, and Abuse for leading the investigation and prosecution of Biodiagnostic Laboratory Services, which resulted in 53 convictions, including 38 physicians – the largest number of medical professionals ever prosecuted in a bribery case.

Professor Elberg has been a leading speaker throughout the country on issues relating to health care fraud and abuse. He has been called upon to teach Department of Justice criminal and civil health care prosecutors from across the country on several occasions, including at the conference launching Deputy Attorney General Sally Yates’s Individual Accountability Initiative. Professor Elberg received his B.A., cum laude and with honors, from Dartmouth College and his J.D., magna cum laude, from Harvard Law School. After graduating law school, Professor Elberg clerked for the Honorable Nancy Gertner, United States District Court for the District of Massachusetts, and then practiced law as an associate at the firm of Dwyer & Collora LLP (now Hogan Lovells) in Boston, where his areas of practice included white collar criminal defense, internal corporate investigations, and general commercial litigation. He is a member of the Massachusetts, New Jersey, and New York Bars.

Scott Danzis is a partner at Covington & Burling, LLP, where he leads the firm’s Medical Device Industry Group. He is a leading expert on the regulation of medical devices, including therapeutic devices, digital health, and diagnostics. Mr. Danzis regularly helps clients navigate their most complex regulatory challenges, including strategies for premarket clearance/approval, postmarket compliance, and enforcement actions. Mr. Danzis previously served in FDA’s Office of the Chief Counsel where he was involved in a wide range of legal and regulatory matters. He speaks regularly at conferences regarding FDA regulation of devices and diagnostics, and teaches a course on FDA law at the Georgetown University Law Center. Mr. Danzis is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review. He also holds a Master’s Degree from George Washington University and a Bachelor of Science from Cornell University.

T. Reed Stephens has a wide array of experience in the life sciences industry, and represents pharmaceutical and biotech manufacturers, wholesalers and individuals, health care systems, and non-health care related companies in other global industries, including the financial services and banking sectors. He is a nationally recognized authority in the pharmaceutical fraud and abuse and corporate compliance spaces, and has extensive experience in Anti-Kickback Statute and Stark Physician Self-Referral Law False Claims Act litigation.

Reed has experience in matters involving state and federal government law enforcement and investigations. He represents hospital systems and managed care companies, and counsels pharmaceutical companies on government drug pricing and voluntary disclosures in the areas of Medicaid Drug Rebate, Federal Supply Schedule/Department of Veteran Affairs, and the 340B program.

Furthermore, Reed advises his clients on risk management concerns involving mergers and acquisitions, public policy, intellectual property protection, and an array of regulatory compliance matters concerning product marketing, foreign bribery prohibitions, and import/export controls.

Previously, Reed was a trial attorney with the U.S. Department of Justice Civil Division, where he led more than 60 investigations, the majority involving allegations of health care fraud perpetrated against various government agencies. Reed was lead counsel for the U.S. in the first successful cases against the pharmaceutical industry, involving Average Wholesale Price (AWP) reporting (US ex rel. Ven-A-Care v. et al.); Medicaid Drug Rebate price reporting (US ex rel. Foster v. Parke-Davis, US ex rel. Alcorn v. Schering-Plough); and Prescription Drug Marketing Act fraud (US ex rel. Gerstein v. TAP Pharmaceuticals).

Robin Blaney is a partner in the firm’s Life Sciences practice.  He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector.  His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements, and tenders.  He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions.  Mr. Blaney writes and speaks regularly on subjects such as medical device regulation, pharmacovigilance and clinical trials.

Hillary Noll Kalay joined UC Legal in January 2016 and provides guidance on clinical research, data initiatives, U.S. and international privacy laws, healthcare compliance, and supports UC Health procurement. Prior to joining UC Legal at UCOP, Ms. Kalay served as Research Policy Manager for the University’s Research Policy Analysis and Coordination unit, developing University policy on clinical research and negotiating and advising campuses on clinical research agreements. Prior to joining the University, she practiced intellectual property litigation at the law firms of Sonnenschein, Nath & Rosenthal (now Dentons) and DLA Piper.

New York University School of Law, JD
University of California, Berkeley, Goldman School of Public Policy, MPP
University of California, Berkeley, BA