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Johnson & Johnson Warned by FDA

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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 the 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

These types of problems are systemic in the whole system. Many blame the FDA for allowing bad drugs to reach the market, but the primary failure is with the drug companies who fail to conduct adequate studies (or worse, hide the results of their otherwise-adequate studies). The FDA does not do independent studies of the drugs—that is not something taxpayers should have to pay for. Drugmakers have a responsibility to perform studies of their own drugs to ensure they meet safety and efficacy requirements. Unfortunately, this is sometimes like the wolf guarding the henhouse.