"We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Gottlieb said in his written statement.
The drug approved Friday is a 30-microgram pill form of sufentanil, a powerful, 34-year-old opioid commonly used after surgery and in emergency rooms.
Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. The committee voted when its chair, Dr. Raeford Brown, who has publicly opposed the application, was not present, and FDA also failed to have the full Drug Safety and Risk Management Advisory Committee participate in the advisory committee meeting, Markey said.
Ted Cruz holds off Beto O'Rourke to keep Texas Senate seat
In August, the Houston Chronicle reported details of a 1998 police report detailing O'Rourke's arrest for drunk driving. But Cruz's friendliness didn't dissuade the comic from continuing to mock him.
President Trump calls CNN's Jim Acosta 'rude, bad person' at press conference
That's such a racist question", Trump said to Alcindor, who is black. You shouldn't be working for CNN, ' the president said to Acosta.
Early Voting Hits Record With 36 Million Ballots Cast
People line up to vote on the last day of early voting at the Minneapolis Early Vote Center Monday, Nov. 5, 2018, in Minneapolis. A volunteer at the polling station at Atherton High School said there appeared to be more voters than in past midterm elections.
"This action is inconsistent with the charter of the agency", wrote Brown, who is also a professor of anesthesiology and pediatrics at the University of Kentucky's medical school. That panel recommended the drug's approval despite his warning. In many cases, illicit users obtain them from friends, relatives or rogue doctors and pharmacists, according to the SAMHSA survey. Indeed, its potential use by soldiers was one reason Dsuvia was approved, according to FDA Commissioner Dr. Scott Gottlieb. The military wants to explore whether the pill can be used as a battlefield painkiller that is less cumbersome than liquid analgesics. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.
"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds".
Pamela Palmer, an anesthesiologist, said she founded the company to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers. "DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA", AcelRx said. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.