HP&M Attorneys to Present Audioconference on Unannounced FDA Raids

September 9, 2009

On September 10, 2009, Hyman, Phelps & McNamara’s John R. Fleder and William T. Koustas will speak at a Thompson Interactive audioconference on FDA’s use of criminal search warrants.  The audioconference, titled “Unannounced FDA Raids: Be Ready Before They Appear at Your Door,” will cover the following issues:

  • When will the FDA use a search warrant rather than a Form 482?  Can an investigator enter your facility if she doesn’t have a 482 or a search warrant?
  • The administrative inspection warrant vs. a criminal search warrant – does one have more power than the other?  How should you prepare for each?
  • Can you prevent an investigator from entering, or block them from access to areas not covered by a warrant?  Can you ask for outside counsel to be present without obstructing justice?
  • What can you ask investigators?  How should you respond to their questions?  Can you follow them throughout the search?
  • How should you manage agent access to other employees?
  • Where should documents be filed and stored before a raid to prevent agents from viewing privileged information they don’t have a legal right to see?
  • Expect the unexpected – preparing for and managing other raid issues like media attention and employee fears.

Additional information on the audioconference, including registration information, is available here.

Categories: Miscellaneous