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WASHINGTON – The Food and Drug Administration on Friday approved a powerful new opioid, despite strong criticism and accusations that it has bypassed its own advisory process.
The new drug, Dsuvia, is a tablet that goes under the tongue. It is designed for use on the battlefield and in other emergency situations to treat acute and severe pain.
Known as sufentanil, this is a new formulation of a drug currently administered intravenously. Critics say it will be extremely easy for health workers to develop the drugs and direct them to the illicit drug market. Given its size and concentration, it probably kills people who overdose.
"It's a dangerous and reckless move," said Dr. Sidney Wolfe, Senior Advisor for the Public Citizen Health Research Group. He wondered whether it was necessary to have another synthetic opioid while the United States was struggling with an opioid overdose crisis.
FDA Commissioner Scott Gottlieb defended the decision in a lengthy statement.
"We understand the concerns about the availability of a formulation with a high content of sufentanil and the associated risks," he wrote.
"There are very strict restrictions on the distribution and use of this product. We have learned a lot about the adverse effects that other opioid oral products may have in the context of the opioid crisis, "Gottlieb added.
"We have applied these difficult lessons as part of the steps we are taking to address Dsuvia's security issues."
But Dr. Raeford Brown, chair of the FDA's Anesthetics and Analgesics Advisory Committee and professor of anesthesiology and pediatrics at the University of Kentucky, said he did not think the FDA had taken enough precautions .
"I am very disappointed with the decision of the agency to approve Dsuvia," Brown said in a statement.
"This action is inconsistent with the charter of the agency. As I said today with the agency's representatives, we have not responded to the lack of data on efficiency, nor to the sponsor's response to security issues, "he added.
"Clearly, the issue of public safety is not important to the Commissioner, despite his attempts to obscure and misdirection."
Brown, who issued critical statements about the FDA in collaboration with Public Citizen, said he had been excluded from the consultation process for Dsuvia. He was not present when his committee voted to recommend approval on October 12th.
"It is certain that Dsuvia will worsen the opioid epidemic and will kill people unnecessarily," said Wolfe. "It will be taken by medical staff and by other people for whom it has not been prescribed. And many of them will overdose and die.
Opioids, including prescription opioids and heroin, killed 42,000 people in 2016, says the CDC. Preliminary figures for 2017 indicate that they killed 49,000. The overdose deaths from opioids are so severe that they have helped reduce life expectancy in the United States.
Synthetic opioids alone have killed 27,000 people in 2017, says the CDC.
Gottlieb said the FDA had carefully considered the risks. He pointed out that opioids require special attention, both because of the overdose epidemic and the fact that Congress has asked the FDA to take into account special considerations when approving opioid products.
They include a control plan for their use, called risk assessment and mitigation strategy. "It can not be distributed to patients for home use and should not be used for more than 72 hours, and should only be administered by a health care provider using a single dose applicator. it will not be available at retail pharmacies for patients to take home, "said Gottlieb.
"I believe that the unique aspects of Dsuvia, including those that make this drug a top priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil-based products in a way that is consistent with the considerations of the population for its integration into a global therapeutic arsenal, "added Gottlieb.
The army requested that the drug be available, he said.
"The FDA is given as a priority to ensure that our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration does not occur. is not possible for the treatment of acute pain related to injuries on the battlefield, "he added.
Wolfe was not in agreement. "It's a terrible decision," he said.
The FDA has already been accused of not taking enough steps to control opioid prescriptions. A team of researchers at Johns Hopkins University, including a former FDA official, published what they believed was evidence that the FDA had done little to stop doctors who prescribed too many opioids.
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