One of the most critical and potentially frustrating components of dealing with the FDA is not following the statutes and regulations, but the process of negotiation with FDA officials.  To resolve disputes with the agency, companies must come to an agreement with the FDA to which they can actually adhere in the future. Often, a dispute calls for high-stakes negotiations in the face of possible individual liability under the Park Doctrine or potentially huge fines resulting from multiple instances of off-label promotion, among other risks. Is your company prepared to handle such a situation?  

Join us for this Free interactive panel with some of the industry’s top experts to help guide you through the complicated process of negotiating with the FDA to resolve enforcement and compliance disputes.    

Learning Points:

• Discuss negotiating enforcement and compliance with government officials dealing with: Injunction actions and consent decrees, GMPs, plea agreements, off-label promotion and  warning letters
• Understand the extent of your ability to negotiate with the FDA and other government agencies

  Meet Your Panel:
Moderator: Arthur N. Levine is a retired partner of the Washington, D.C., law firm of Arnold & Porter L.L.P., where he counseled pharmaceutical and medical device companies on a wide variety of compliance and regulatory issues.

Mr. Michael Hinckle is a partner with K&L Gates.  His practice focuses on counseling corporations and individuals on all aspects of FDA regulatory and corporate matters

Mr. Mailhot is a special counsel in the Washington D.C. office, and is a member of the firm's Food and Drug Law Group, as well as the firm's Life Sciences group. Mr. Mailhot's 14 years working in the U.S. Food and Drug Administration (FDA) provides a unique perspective in his counseling of clients on a broad range of matters involving the FDA.