SOPs NEEDED IN ADVANCE AS PROTECTION AGAINST FDA CRIMINAL INVESTIGATIONS

Executive Summary

SOPs NEEDED IN ADVANCE AS PROTECTION AGAINST FDA CRIMINAL INVESTIGATIONS to prevent company personnel from waiving their Fourth Amendment rights against illegal search and seizure, D.C. lawyer John Fleder advised at a Food & Drug Law Institute conference June 23. "Have a lawyer develop and help implement standard operating procedures and other written guidance advising the employees" what actions to take when approached by FDA investigators, either at the firm or at their homes, Fleder recommended. Without such SOPs, Fleder said, "the employee may waive invaluable constitutional rights."