The Food and Drug Administration (FDA) is taking heat for approving a powerful, fast-acting opioid.
The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT. The drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use.
The FDA has approved this new drug in the midst of a severe opioid epidemic in the country. According to critics, the decision will only fuel the United States' drug crisis even further rather than improving it.
But public advocacy groups were quick to condemn the decision because they fear it will lead to more overdoses. Alan says the concern around the drug is "valid given the potential for abuse". It's an alternative to IV painkillers used in hospitals. 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.
Also on Friday, the Drug Enforcement Administration released a report showing that prescription drugs were responsible for the most overdose deaths of any illicit drugs since 2001.
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A panel of FDA advisers had earlier voted 10 to three in favor of the pill called Dsuvia, but in a rare response, the panel's chairman joined critics in urging the FDA to reject it.
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Sidney Wolfe, founder of Public Citizen's Health Research Group, said in a statement. Already, it's clear that in the context of the opioid crisis, "our evaluation of opioids is different than how we assess drugs in other therapeutic classes", Gottlieb noted.
The FDA also said it had signed a memorandum of understanding with the Defense Department to expedite availability of medical products, particularly those used to treat injuries in battlefield settings. Company executives said they expect to launch Dsuvia in the first quarter of 2019. According to Gottlieb, "This opioid formulation, along with Dsuvia's unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield".
And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids.
"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement.