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Trk 10: Pub Pol-HealthCare Compl-Law [clear filter]
Sunday, June 26

8:30am EDT

#20: The Sunshine Act: Understanding the Essentials of Compliance
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

As part of the Affordable Care Act of 2010, the Sunshine Act was enacted. This law is designed to inject greater transparency for the public to understand the relationship between pharmaceutical and medical device companies and the physicians and teaching hospitals that are most likely prescribing their products. The Sunshine Act imposes a duty on “applicable manufacturers” of “covered” drugs and devices to both track and disclose not only payments made to physicians and teaching hospitals in the form of consulting fees, honoraria, etc., but also any other provision of an item or service that has a value to such recipients, including meals, trips, research equipment, etc. And, annually all such payments need to be submitted to a website maintained by the Center for Medicare and Medicaid Services (CMS) for public review.

This tutorial will explore in detail the Sunshine Act’s requirements, including any potential exemptions, and also the unique way that the Sunshine Act deals with research-related payments, which overlaps in part with the separate provisions in 21 CFR Part 54 that FDA imposes for the disclosure of financial interests held by clinical investigators. The basics of the system and process for submitting the required disclosures to the CMS “Open Payments” database and suggestions on how to implement processes at their companies to ensure compliance with the Act’s requirements will be discussed.

Who should attend?

This tutorial is designed for all personnel responsible for ensuring compliance with the Sunshine Act.

Learning Objectives

• Discuss how the Sunshine Act is structured;
• Identify key definitions that impact duties under the Sunshine Act, including when a product is “covered” so as to potentially render the manufacturer responsible for disclosing payments;
• Identify the many different types of payments or provision of other things of value that must be tracked and disclosed under the Sunshine Act.

avatar for Michael Swit

Michael Swit

Senior Director, Legal, Regulatory, Illumina, Inc.
Michael A. Swit, Esq., has solved vital FDA legal issues since 1984, with a focus on drug and device challenges. Before joining Illumina as its senior regulatory counsel in December 2014, he was a Special Counsel in the FDA Law Practice at Duane Morris, a global law firm. He also... Read More →

Sunday June 26, 2016 8:30am - 12:00pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 10: Pub Pol-HealthCare Compl-Law, Tutorial
Tuesday, June 28

4:00pm EDT

#268: Emerging Biopharma Therapeutic Modalities: Scientific and Policy Implications
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will examine three emerging scientific platforms with potential to drive the next wave of therapeutic innovation. Participants will be presented with how to evaluate new platforms, recognize the hurdles and consider what regulatory pathways and policies are needed to bring these new therapies to patients.

Learning Objectives

Discuss three emerging therapeutic modalities and what aspects make them particularly useful as new therapies; Define the characteristics of each modality that present the most significant near-term challenges and inflection points for greater therapeutic utilization; Recognize what policies are needed to ensure development and delivery of these innovations as new therapeutics.


Adam Hacker, PhD


Microbiome: What Is It and Why Do We Need to Prepare for It?
Adam Hacker, PhD

Regenerative Medicine: How Adaptive Biomedical Innovation Can Support Development of Cell and GeneTherapy Products
Anne-Virginie L. Eggimann, MS

Responding to Global Health Emergencies: A Regulatory Perspective
Luciana Borio, MD

avatar for Adam Hacker

Adam Hacker

Vice President, Head of Vaccines & Microbiome, Global Regulatory Affairs, Janssen Pharmaceuticals (johnson & Johnson)
Adam Hacker was appointed VP Head of Vaccines & microbiome for Global Regulatory Affairs at Janssen Pharmaceuticals (Johnson & Johnson company) in June 2015. As Head of Vaccines he is responsible for driving regulatory strategy with a focus on the accelerated development of Janssen’s... Read More →

avatar for Luciana Borio

Luciana Borio

Acting Chief Scientist, Office of the Chief Scientist, OC, FDA
Dr. Luciana Borio is FDA’s acting chief scientist. In this capacity, she is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership... Read More →
avatar for Anne-Virginie Eggimann

Anne-Virginie Eggimann

Senior Vice President, Regulatory Science, bluebird bio, Inc.
Anne-Virginie joined bluebird bio in 2011 to lead global regulatory strategy and create innovative pathways to accelerate the development of bluebird bio’s gene therapy products. Previously, AV was an Executive Director at Voisin Consulting, leading rare diseases, oncology, and... Read More →

Tuesday June 28, 2016 4:00pm - 5:15pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol-HealthCare Compl-Law, Session
Wednesday, June 29

2:00pm EDT

#345: Are State Consumer Fraud Lawsuits Encroaching on FDA’s Regulatory Authority?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-564-L03-P; CME 1.25; IACET 1.25; RN 1.25

FDA, under the Food, Drug and Cosmetics Act (FDCA), has clear authority over, among other things: (1) the content and format of prescription drug labeling and promotional materials, (2) compliance with current prescription drug, device, and product manufacturing practices, and (3) product withdrawals from the market. Yet, each of these matters has been the subject of recent litigation filed by State Attorneys General under a theory that alleged violations of these federal laws can be brought in state court using broad, generalized state law causes of action, such as state unfair and deceptive practices acts. This forum will discuss how state court juries have been presented with questions that historically have been decided by FDA, such as whether FDA-approved labeling is false, or whether a FDCA violation warrants a warning letter or even more significant actions or penalties. In addition, the consent decrees resulting from these lawsuits can give states FDA-like regulatory authority over health care companies, prospectively.

Learning Objectives

Identify the implications of state involvement in issues historically reserved for FDA on the public health, industry, and the Agency itself.


Lisa M Dwyer, JD


JB Van Hollen, JD

Sheldon Bradshaw, JD

avatar for Lisa Dwyer

Lisa Dwyer

Partner, Member of the FDA and Life Sciences Group, King & Spalding
Lisa has more than 15 years experience working with legal and policy matters involving all FDA-regulated products. From 2010-2015, she served in the Commissioner’s Office at FDA as a Senior Policy Advisor, in the Office of Policy, and as the Deputy Chief of Staff to the Commissioner... Read More →

avatar for Sheldon Bradshaw

Sheldon Bradshaw

Partner, FDA and Life Sciences Practice; Former Chief Counsel, FDA, King & Spalding
Bradshaw’s practice focuses on providing legal and regulatory assistance to both large multinational corporations and small growth companies regarding products regulated by the FDA. Prior to joining Hunton & Williams in 2007, Bradshaw served as FDA’s Chief Counsel from 2005 to... Read More →
avatar for JB Van Hollen

JB Van Hollen

Former State Attorney General for Wisconsin, Van Hollen Consulting, LLC
Prior to becoming Attorney General for the State of Wisconsin, JB was appointed United States Attorney for Wisconsin’s Western District in 2002 where he served until 2005. He also served as a District Attorney in both Ashland and Bayfield Counties subsequent to serving as both an... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA