Despite Warnings, FDA Approves Potent New Opioid Painkiller
November 2, 20183:05 PM ET
JAKE HARPER
The Food and Drug Administration has approved a potent new opioid painkiller, despite warnings from physician critics who say the drug will contribute to the addiction epidemic.
Dsuvia, a 3-millimeter-wide tablet of sufentanil made by AcelRx, came before an FDA advisory committee on Oct. 12. Such committees weigh in on the safety and efficacy of proposed products, and the FDA generally follows committee guidance in its decisions about drugs. The FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend approval for the medication, and the agency approved the drug Friday.
"There are very tight restrictions being placed on the distribution and use of this product," said FDA Commissioner Scott Gottlieb in a written statement Friday regarding his agency's approval of Dsuvia. "We've learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We've applied those hard lessons as part of the steps we're taking to address safety concerns for Dsuvia."
But vocal critics, including the chair of the FDA advisory committee and the consumer advocacy group Public Citizen, had urged the FDA to reject Dsuvia.
In approving the drug, the agency skirted its normal vetting process, these critics say. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.
https://www.npr.org/sections/health-shots/2018/11/02/663395669/despite-warnings-fda-approves-potent-new-opioid-painkiller
Let me see if I understand the head trump asshole at the FDA.............Food and Drug Administration Commissioner Scott Gottlieb and how he equates putting a fucking opoid out into the country when this country is going through a national crises on over doses, and addiction and is staining the health care system more.......................but nope, not Scott Gottlieb, he thinks that a company that wants to make a profit, should make a profit..........................I guess Gottlieb hasn't been reading newspapers or watching the tv lately.................
https://www.motherjones.com/politics/2017/11/trumps-opioid-commission-just-released-its-final-recommendations/
https://www.motherjones.com/crime-justice/2017/12/opioids-users-dealers-police-1/
https://www.motherjones.com/politics/2017/11/the-opioid-epidemic-is-devastating-its-also-really-expensive/
And then there is the Slacker Family.........................
https://www.washingtonpost.com/news/business/wp/2018/09/08/the-man-who-made-billions-of-dollars-from-oxycontin-is-pushing-a-drug-to-wean-addicts-off-opioids/?utm_term=.73c675fd8d43
= new reply since forum marked as read
