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Wednesday, June 29 • 2:00pm - 3:15pm
#345: Are State Consumer Fraud Lawsuits Encroaching on FDA’s Regulatory Authority?

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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.

Chair

Lisa M Dwyer, JD

Speaker

Panelist
JB Van Hollen, JD

Panelist
Sheldon Bradshaw, JD


Chair
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 →

Speakers
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
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol-HealthCare Compl-Law, Forum