FDA Commissioner Scott Gottlieb issued a special statement on the approval of the new drug, Dsuvia, noting that its use will be strictly controlled and that the agency understands the controversy behind its decision, the Washington Post reported.
“It fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield,” Gottlieb said, noting that the drug will be sold in the form of a 30-microgram tablet designed to be put under the tongue, making it more suitable for battlefield situations where people cannot easily inject a drug.
Public Citizen, a consumer rights advocacy group, objected to Dsuvia’s approval, as did Raeford Brown, the chairman of the FDA advisory committee, who wasn’t present during the vote regarding the drug.
“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly. It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die,” Sidney Wolfe, the founder of Public Citizen’s Health Research Group, said in a statement.
“We need to address the question that I believe underlies the criticism raised in advance of this approval. To what extent should we evaluate each opioid solely on its own merits, and to what extent should we also consider … the epidemic of opioid misuse and abuse that’s gripping our nation?” Gottlieb wrote in his statement.
The US is facing what has been called the worst drug crisis in the country’s history, with overdoses killing a record 72,000 users in 2017, according to preliminary data from the US Centers for Disease Control and Prevention. As in 2016, which had a death toll of approximately 64,000, the 2017 US death toll from drug use was higher than all US military casualties in the Vietnam and Iraq wars combined.