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NEW YORK — The Food and Drug Administration has warned Johnson & Johnson that it did not properly monitor two human tests of its antibiotic drug candidate ceftobiprole, which is intended to treat complicated skin infections like MRSA.
The agency has twice delayed approval of ceftobiprole, citing similar problems. It said Johnson & Johnson violated the protocols of its own study, by, for example, not making sure patients were storing the drug properly when using it at home. The FDA also said Johnson & Johnson failed to document some doses given to patients, did not conduct thorough examinations of all patients, enrolled some patients who did not meet its own eligibility criteria for the study, and hired unqualified investigators.
The warning letter, dated Aug. 10, was posted to the FDA's Web site Tuesday. The agency gave Johnson & Johnson 15 working days to explain the precautions it will take to prevent similar problems in the future. The letter warns of potential "regulatory action" if the company does not detail its response.
The agency sends warning letters when it is concerned about violations that could threaten the value of data being collected in the trial, or compromise the rights, safety or welfare of patients, said FDA spokeswoman Pat El-Hinnawy.
El-Hinnawy said she could not detail what actions the FDA would take against J&J while the case is under review by FDA scientific investigators.
"The finest option, and the one that everyone hopes for, is that there will be corrective action taken, meaning the deficiencies that were noted would be corrected," she said.
Ernie Knewitz, a spokesman for Johnson & Johnson Pharmaceutical Research & Development LLC, had no comment on the particulars of the warning letter, but said the company is preparing a response.
"We have a period of time to react to the letter and address their questions. We have people working on that right now," he said in a telephone interview.
In addition to the FDA's postponements, the European Union also delayed a ruling on the product in February. Basilea Pharmaceutica Ltd., which licensed the drug to Johnson & Johnson in 2005, filed a lawsuit against the New Brunswick, N.J.-based drugmaker, saying it has been hurt by the delays.
One of the two studies was started by Basilea and taken over by Johnson & Johnson, the world's biggest maker of healthcare products. J&J conducted the second study on its own.
