FDA Rejects Advisers,
Won't Expand Use of J&J Drug
By SHIRLEY S. WANG
August 22, 2008; Page B7
The Food and Drug Administration declined to approve expanded use of a Johnson & Johnson antibiotic despite an advisory panel's favorable recommendation, marking the third time this month the agency hasn't followed the guidance of its outside experts.
The FDA says it needs more information from J&J before it can approve Doribax to treat hospital-acquired pneumonia. The drug is approved for use in serious cases of abdominal and urinary-tract infections.
Although the agency isn't obligated to follow advisory committees' recommendations, it commonly does. But in early August, the FDA decided to reject Schering-Plough Corp.'s sugammadex, a drug that helps patients recover from anesthesia, even though the panel decided unanimously to approve it. A week later, the FDA said it needed three more months before it would decide whether to green-light ustekinumab, a J&J biologic drug for treating psoriasis, despite another panel's unanimous vote for approval.
These decisions offer yet another sign of the FDA's increasing cautiousness as well as its heightened attention to safety. The agency appears to be taking more time and asking for more data before it makes decisions. In 2007, the FDA approved the fewest number of new drugs -- 19 -- in more than two decades and ordered new or enhanced "black-box" warnings -- the most serious type -- for about 75 drugs, double the number from four years ago.
In the case of Doribax, the advisory panel's decision was mixed. Members voted 7-6 that the drug was efficacious and by 8-5 that it was safe, and several of them questioned design aspects of the study used to test the drug.
J&J, of New Brunswick, N.J., said it "is reviewing the agency's letter and will work to resolve any outstanding questions."
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