We are disappointed with the Food and Drug Administration’s (FDA) warning to Johnson & Johnson (JNJ) on clinical trial related issues. The agency cautioned the company for not maintaining proper records and checks during the trial of ceftobiprole. Ceftobiprole is a broad-spectrum antibiotic for methicillin-resistant staphylococcus aureus (MRSA) and is being studied for the treatment of complicated skin infections and nosocomial pneumonia. In 2005, Basilea Pharmaceuticals licensed the drug to J&J.

The new drug application (NDA) for the drug is pending since May 2007. Protocol related issues came up even during the initial stages. In November 2008, the FDA issued a Complete Response letter asking J&J to conduct additional audit work of clinical investigation sites and to address questions related to site monitoring.

The latest decision by the FDA proves that the company has not been able to convince the agency yet. Some of the violations include inability to ensure proper storage of the drug while patients were using it at home, failure to maintain proper documents on the dosage, not examining all the patients thoroughly, enrolling some patients who did not meet its own eligibility criteria for the study and hiring unqualified investigators.

Apart from the postponement of the FDA’s decision, the European Union (EU) also delayed a ruling on the drug last February. The review process has been halted until a Good Clinical Practice inspection is completed. The drug was launched in Canada and Switzerland last year under the trade name Zeftera.

The concerns raised by the FDA will push back the NDA approval. At present, Johnson & Johnson has 15 working days to explicate its corrective action. The FDA has threatened to take “regulatory action” if the company fails to give a detailed response. We hope J&J comes up with a comprehensive map of the course of corrective action to satisfy the FDA.

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