Last week, the FDA sent a warning letter to Johnson & Johnson over trials of its antibiotic drug, ceftobiprole. J&J hopes that Ceftobiprole will be approved for treatment of skin infections, including MRSA (which is frequently a hospital-acquired infection).
The FDA reports that J&J has been violating its own study protocols, including:
- Failure to ensure that patients properly store the drug
- Failure to perform appropriate patient examinations
- Failure to document some doses given to patients
- Hiring unqualified investigators
- Enrolling patients who do not meet J&J’s own eligibility criteria