The FDA may detain and ultimately refuse the admission of food, drugs, devices and cosmetics offered for import if the products “appear” to violate regulatory requirements. FDA also may subject products, manufacturers, and countries to “detention without physical examination.” These FDA authorities are significant, as 40% of the drugs Americans take are manufactured outside the U.S., and 80% of active pharmaceutical ingredients come from non-U.S. sources. In 2011, more than 24 million shipments of FDA regulated products will be offered for import.

In recent years, lawmakers have pressed FDA to monitor imports more closely, driven by incidents of fatal drug contamination – like the 2008 incident involving the blood thinner Heparin. In response, FDA has launched new enforcement initiatives and increased the number of import holds, detentions and refusals. So how can importers adjust to this new reality? And what should they do if they run afoul of FDA? This audio conference presentation explains FDA’s powers in this area, recommends steps to avoid import problems, and describes how to fight holds, detentions and refusals.

This audio conference covers:

• A review of FDA's authority over the importation of food, drugs, devices and cosmetics
• How FDA flags imports for review and inspection
• How to reduce the likelihood that your import will be flagged for review and inspection
• How to communicate with FDA about held/detained products
• How to challenge FDA holds, detentions and refusals
• How to obtain authorization to recondition detained products
• How to obtain removal from detention without physical examination

About the speaker:

Kyle Sampson is a partner in the Washington office of Hunton & Williams LLP and a member of the firm's food and drug practice. His practice focuses on FDA regulatory, compliance and enforcement issues. Kyle represents food, drug, biologics, medical device, cosmetic, and dietary supplement companies on the full range of regulatory and enforcement issues confronting FDA-regulated firms. During his professional career, Kyle has engaged in extensive public service in every branch of the federal government, serving in the White House from 2001 to 2003 as Associate Counsel to the President, and at the Justice Department from 2003 to 2007 as a Special Assistant U.S. Attorney and senior advisor to two Attorneys General. Kyle also served as Counsel to the U.S. Senate Judiciary Committee from 1999 to 2001. After law school, Kyle clerked for the Hon. Karen J. Williams of the U.S. Court of Appeals for the Fourth Circuit.

Who should attend?

• General Counsel
• Assistant General Counsel
• Associate General Counsel
• Chief Compliance Officers
• Compliance Officers
• Vice Presidents, Quality
• Vice Presidents, Regulatory
• Vice Presidents, Global Trade