FDA OKs Strong Opioid Pill 10 Times Stronger Than Fentanyl Despite Abuse Concerns
Health experts said the pill isn't needed and will only worsen the opioid epidemic. The Food and Drug Administration endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical. Other news on opioids focuses on the FDA's armed hunt for counterfeit drugs and the continued threat of fentanyl and heroin.
The Associated Press:
FDA OKs Powerful Opioid Pill As Alternative To IV Painkiller
The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield. The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor. (Johnson, 11/2)
NPR:
FDA Approves Potent New Opioid, Despite Abuse Concerns
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. (Harper, 11/2)
Stat:
The FDA, But With Guns: A Little-Known Team Tracks Down Counterfeit Drugs
But this wasn’t an FBI sting or DEA operation. The lead agent in that hotel room was Spencer Morrison, of the Food and Drug Administration’s Office of Criminal Investigations. The OCI, it turns out, is staffed by 300 gun-toting officers, all of them employees of the same bureaucracy that issues food recall notices and verifies that medicines are safe and effective. But it is little-known in Washington or beyond. (Florko, 11/5)
The Associated Press:
Feds Say Heroin, Fentanyl Remain Biggest Drug Threat To US
Drug overdose deaths hit the highest level ever recorded in the United States last year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Most of that was the result of a record number of opioid-related deaths. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. About a week ago, U.S. Health and Human Services Secretary Alex Azar said overdose deaths, while still slowly rising, were beginning to level off, citing figures from late last year and early this year. (Balsamo, 11/2)
The FDA also eyes vaping —
Bloomberg:
Juul Is So Hot It’s Set The Vaping Debate On Fire
The Juul e-cigarette was created to help adult smokers quit, according to the company that makes it. Its developers wanted to make the experience of getting a stimulating hit of nicotine dramatically better than sucking on a stinky, smoking stick of burning tobacco. Their success made Juul the top-selling e-cigarette in the U.S. in two years, but it achieved that position in part by attracting a huge following among kids younger than 18, who aren’t legally allowed to purchase such products. Concerns about the hazards of vaping for the young have provoked the U.S. Food and Drug Administration to warn that it will tighten regulations on e-cigarettes unless their makers convince the agency they will combat use by minors. (Edney, Alexander and Zaleski, 11/5)