FDA Clinical Investigator Warning Letter (Phase 4 study)

FDA posted a warning letter to a Clinical Investigator this week for activities on a Phase 4 study of Chantix (varenicline) by Pfizer. Three FDA inspectors conducted the inspection, which lasted over one month. 

Dr. Curtis was warned for:

  • Failing to follow the investigational plan
    • Enrolling two subjects who did not smoke enough cigarettes per day
    • Enrolling one subject who did not meet enrollment criteria for amount of carbon monoxide exhaled at screening
    • Enrolling a subject who was taking prohibited concomitant medications
  • Failing to maintain adequate and accurate case histories
    • Failing to complete three summary score sheets to determine psychiatric symptoms, but entering a summary score into the electronic Case Report Form (CRF)
  • Failing to maintain adequate records of drug accountability
    • FDA compared drug amount dispensed versus amount returned versus the calculations of what should have been returned and compared it to the CRF entries

FDA notes that the Investigator's initial response to the 483 relied heavily on changes to institutional SOPs and did not account for any specific actions by the investigator to prevent issues in the future. FDA stated that this prevented them from determining the adequacy of the response.