The Food and Drug Administration (FDA) approved a highly controversial opioid.
Dsuvia, made by AcelRx Pharmaceuticals Inc., is a tablet in a single-dose, prefilled applicator to be administered under the tongue by health care providers to patients in settings such as hospitals, surgical centers and emergency rooms, according to the company. Dr. Gottlieb indicated the FDA will re-evaluate its consideration of individual and public health impacts of new approved opioids entering the market.
Along with the approval, Commissioner Scott Gottlieb released a statement of more than 2,200 words explaining the decision as well as how the agency will consider future opioid applicants.
Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data.
Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis. Gottlieb noted Dsuvia was "a priority medical product for the Pentagon" and the military's use "was carefully considered in this case". On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record previous year with 72,000 deaths - about 200 per day.
The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield.
More: The opioid crisis hits home.
But Dsuvia's approval comes amid controversy, with an epidemic of opioid abuse continuing to ravage the United States.
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group. Diversion, of course, is the term used to describe how drugs end up in the hands of someone other than the intended patient.
Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death.
In approving the drug, the agency skirted its normal vetting process, these critics say.
"I am very disappointed with the decision of the agency to approve Dsuvia".
Emalie Gainey, a spokeswoman for state Attorney General Maura Healey, said Healey has "serious concerns" about Dsuvia and "will be monitoring this closely". It is expected to be available in the first quarter of next year.
"We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", AcelRx CEO Vince Angotti said in a statement.