Surviving an FDA Disgorgement Action: Frontline Strategies to Defend Against the FDA's Billion-Dollar Enforcement Tool
Product Details
Held April 24, 2007Disgorgement actions have already cost drug manufacturers and devicemakers almost a billion dollars for everything from GMP violations to problems with off-label promotions. Schering-Plough paid $500 million in penalties for just one action, but there’s no limit to how much the FDA can seek.
Although disgorgement is an intimidating enforcement weapon, you won’t find it in any regulatory statute. There’s no guidance — and zero restrictions — on when the FDA will invoke it. So how can you protect yourself?
What can you do to avoid one of the most powerful weapons in the FDA’s arsenal?
In this 90-minute audio CD/transcript, noted attorney and former FDA associate chief counsel William Vodra arms you with today’s absolute best strategies for managing the risk of disgorgement. Drawing on his own firsthand experience in FDA disgorgement proceedings, he shows you how to respond effectively to any FDA proposal for disgorgement. William also walks you through what to do if all else fails — including how to meet the FDA head-on in court with strong legal arguments never considered in the landmark United States v. RxDepot case.
You will learn how to:
- Implement strategies to help prevent disgorgement proposals from arising
- Avoid three common mistakes that can flag your company for disgorgement action
- Target three types of violations most likely to trigger disgorgement
- Use five key strategies to respond to FDA disgorgement demands
- Anticipate the FDA’s novel methods for calculating disgorgement amounts
- Reduce excessive demands — even deflect disgorgement altogether
- Fight disgorgement in court — the four arguments that have failed so far and the three new ones that give you the best chance of winning
Don’t wait — shore up your anti-disgorgement defenses before you must gut earnings to repay millions of dollars! Order now. You'll have an opportunity to hear specific issues raised during the Q&A session.