The FDA’s New Civil Penalties:How Simple Violations Could Cost You Millions

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When Congress passed the FDA Amendments Act (FDAAA) giving the FDA the power to regulate clinical trials, risk evaluation and mitigation strategies (REMS) and direct-to-consumer (DTC) advertising, it also provided for exorbitant civil consequences for violations, including:
  • $10,000 a day for clinical trials information that is false, misleading or not submitted to the national registry
  • One million dollars for violating a REMS requirement and up to $10 million additional in fines for continued violations after notice from the HHS secretary
  • $250,000 for the first instance of disseminating false or misleading DTC ads and $500,000 for each additional violation within a three-year period after notice from the HHS secretary

And now, nearly a year later, Congress and public interest groups are putting the pressure on the agency to crack down on noncompliance and invoke its new power.

Understand these new rules, have best practices and strategies in place to comply with them and avoid potentially devastating penalties — including huge fines, bad publicity and the possibility of congressional scrutiny.

Gain the knowledge you need to allay your fears and concerns …

In a 90-minute Encore presentation, Arnold & Porter’s Vernessa Thomas Pollard and Dan Kracov will detail what you need to do to comply with the new laws to avoid being penalized, trends in the FDA’s use of civil penalties and what to expect in the near future.

Sign up your entire team to listen in and discover:

  • All the facets of the new penalties and the violations that trigger them
  • How the agency determines the amounts of the fines
  • What aspects of the violations the FDA considers when imposing penalties
  • The highest areas of risk that could cost you the highest penalties
  • 10 dos and don’ts for avoiding civil penalties
  • An overview of the FDA’s use of civil penalties

Register now and find out what you need to know about the FDA’s new civil penalties and how to avoid them. Plus, you’ll get an opportunity to ask your toughest questions during the Q&A session.

This presentation is a must for positions in the drug, device and biologic industry, including:

  • Compliance officers
  • Sales and marketing professionals
  • Medical affairs
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Senior management
  • R&D officials

Vernessa Thomas Pollard is counsel in Arnold & Porter's FDA and healthcare practice group, where she focuses her practice on a variety of regulatory, policy and litigation matters. Prior to joining Arnold & Porter, Vernessa spent six years as Associate Chief Counsel for Enforcement in the Office of Chief Counsel at the FDA, where she represented the agency in a variety of enforcement actions and defensive litigation matters. During her tenure at the FDA, she advised agency clients and DOJ lawyers on a wide range of compliance and regulatory matters involving drugs, dietary supplements, cosmetics, medical devices, pharmacy compounding, product labeling, GMP requirements, disclosure of records under the Freedom of Information Act (FOIA), and responding to Congressional inquiries.

Dan Kracov heads the pharmaceutical and medical device practice at the law firm Arnold & Porter. He assists clients — including start-up companies, trade associations and large manufacturing companies — in negotiating the challenges relating to the development, approval and marketing of drugs, biologics and medical devices. His experience in the FDA’s strategic advice and crisis management won him a spot on the Fall 2005 Legal Times list of "Leading Lawyers in Food & Drug Law." Dan regularly handles product- and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has widely recognized experience in biomedical-product-related public policy matters, including Congressional investigations and FDA-related legislative strategies.

Register now!

Date: Dec. 8–26, 2008
Location: Your office or conference room (no need to travel!)
Time: Anytime

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