FDA Warns J&J About Breaking Rules on Experimental Antibiotic

Drug Goliath Johnson & Johnson is being reprimanded by the Food and Drug Administration for violating established rules for clinical studies of the company’s experimental antibiotic.

J&J is working on developing a drug called ceftobiprole, which the company says may effectively fight antibiotic-resistant infections such as MRSA (methicillin-resistant Staphylococcus aureus), C. diff (Clostridium difficile), and other so-called “Super Bugs.” The company is seeking FDA approval to market the drug as a treatment for diabetic foot infections and other complicated skin infections, but the FDA is holding up the process due to concerns about irregularities found at some locations where the clinical studies were conducted.

The FDA’s warning letter, dated August 10, was posted today on the agency’s website.

Legal Fight Underway

Ceftobiprole is a joint venture between J&J and Swiss drug company Basilea Pharmaceutica AG. The two companies are now at war in court over Basilea’s claim that J&J breached their contract by not securing FDA approvals of the drug and for failing to properly develop the drug for use as a pneumonia treatment.

The drug is approved and available in Canada and other countries, but European Union regulators have held off approving the drug until they complete inspections of the drug’s clinical trials data.

Clinical Study Irregularities

In the warning letter, the FDA said it wants more information about J&J’s part as a sponsor of the clinical trials and assurances that the clinical trial results were accurate and not gathered at the expense of the welfare and safety of study participants.

Also, the FDA said its investigation found that J&J did not properly monitor the clinical trials and used unqualified investigators to conduct the studies, which allowed deficiencies in record keeping to happen, according to a CNN Money report.

J&J, which now has two weeks to respond to the FDA warning letter, said it expects to resolve the issue promptly.

J&J spokesman Ernie Knewitz said the FDA’s warning letter was “regarding the responses submitted to questions initially raised by the agency involving the development of ceftobiprole. We will continue to work with the agency to address their concerns,” according to the CNN Money report.

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