Biotech Values

[DewDiligence]

FDA Again Overrules Advisory Panel

http://blogs.wsj.com/health/2008/08/21/fda-delays-doribax-spurning-expert-advice-again

›August 21, 2008, 12:28 pm
by Shirley S. Wang

For the third time this month, the FDA has ignored a recommendation from outside experts to approve a marketing application for a drug.

This time the setback was dealt to Johnson & Johnson’s intravenous antibiotic drug Doribax. The agency says it needs more information before it can decide on the use of Doribax to treat the nasty kind of pneumonia patients pick up in hospitals. FDA approved Doribax last year for treatment of serious abdominal and urinary tract infections.

Although not obligated to follow the recommendations of advisory committees, FDA historically has done so. But in early August, it decided to reject Schering-Plough’s sugammadex, even though the committee decided unanimously to approve it [#msg-31141155]. A week later, the FDA said it needed three more months before coming to a decision about J&J’s psoriasis medicine, ustekinumab, despite another advisory committee’s unanimous vote for approval.

“Usually you would expect the FDA to agree with its panels, but isn’t hasn’t been quite doing that,” Mike Krensavage of Krensavage Asset Management told the Health Blog. “I think it’s another sign that the FDA is being increasingly cautious about approving new drugs.”

At least in the case of Doribax, the outside experts’ decision was mixed. Panel members voted 7 to 6 that the drug was efficacious for hospital-acquired pneumonia and also in a split decision that it was safe. Some questioned the company on aspects of the study design.

J&J says in a statement that it “is reviewing the agency’s letter and will work to resolve any outstanding questions.”‹