The Food and Drug Administration (FDA) is getting the side-eye after approving a painkiller that's said to be 1,000 times stronger than morphine.
For Dsuvia specifically, Gottlieb referenced the opioid multiple times as a Pentagon priority, citing its potential use on the battlefield to treat soldiers through its sublingual formulation.
The rate of overdose deaths among health care workers is relatively high, however, according to an August study by the Centers for Disease Control and Prevention, with 876 succumbing to prescription opioids between 2007 and 2012.
The FDA has approved this new drug in the midst of a severe opioid epidemic in the country.
The medication should not be used for more than 72 hours at a time, according to the FDA. The most notable of these critics might actually be in-house: the chair of the FDA advisory committee, who also happens to be the chair for the consumer advocacy group Public Citizen. "To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider.the epidemic of opioid misuse and abuse that's gripping our nation?" Alan says the concern around the drug is "valid given the potential for abuse". In its newly approved form, it is an option for patients with acute pain who are not able to receive an IV or are unable to swallow a pill.
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Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis.
Last month, FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that Dsuvia be approved. Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug. In a statement, FDA Commissioner Scott Gottlieb, MD, sought to deflect criticism of the approval, saying that, "Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that's available to patients and providers". Angotti noted that the drug will be subject to a Risk Evaluation and Mitigation Strategy program.
In a statement, he said, "The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain". The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies.
"It's a huge mistake", Wolfe said. Company executives said they expect to launch Dsuvia in the first quarter of 2019.
"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.