Sample medical product safety concerns by category of perceived problems.
CATEGORY OF PERCEIVED
PROBLEM
SAMPLE ISSUESRECENT
EXAMPLES
ADDRESSED
BY § 801?
Design, conduct, or analysis
  • Appropriateness of comparator

  • Lack of data integrity/fraud

  • Insufficient informed consent

Arcoxia (35)
Ketek (34)
Trovan (33)
No
Lack of public information   
Observational study
  • Suppression of trial existence and results

Paxil (40)
Vioxx (30)
Zetia (31)
Yes
Clinical trial
  • Suppression of study existence and results withheld

Baycol (39)
Trasylol (36)
No
Postmarket adverse event reports
  • Failure to disseminate data

ICD* (41)No
  • *Ventak Prizm 2 DR implantable cardioverter-defibrillator.

  • † For example, postmarket surveillance is addressed in FDAAA

  • § 905.