FDA Committee Chair Criticizes Panel for Yes Vote on Opioid

The chair of an FDA advisory committee took the unusual step of publicly denouncing the panel’s vote for an opioid candidate.

Earlier this month, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend AcelRx’s Dsuvia for combating moderate-to-severe acute pain.

The agency initially nixed the drug last year citing a dearth of safety data but did an about-face when the company filed a new application. In a letter, co-written with the advocacy group Public Citizen, Committee Chair Raeford Brown — who was unable to attend the advisory committee meeting because of a prior commitment — said the evidence still fell short, insisting there was no way to confirm the anti-diversion risk strategy the drugmaker promised will work.