An FDA expert panel chairman defies his own panel for endorsing an opioid painkiller

In an unusual move, the chair of a Food and Drug Administration panel is defying a recommendation that his own panel made last week to endorse a powerful opioid painkiller, because he believes the drug represents a “danger” to public health. And to make sure his views are known, Dr. Raeford Brown, the panel chair, conveyed his concerns in a letter on Thursday to FDA officials.

At issue is Dsuvia, which the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee last Friday voted 10-to-3 to recommend for combating moderate-to-severe acute pain, but only for adults in medically supervised settings. The drug is a tablet version of an opioid that is marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator.